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Last Updated: March 28, 2019
Research Compendium
NexJ Health: Research Compendium
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Table of Contents
Table of Contents .............................................................................................................. 2
NexJ Health’s Dedication to Research and Evidence .................................................... 4
Chronic Disease is Healthcare's Greatest Challenge ........................................................................ 4
Research Trials & Publications ............................................................................................................ 4
Patient Engagement .............................................................................................................................. 5
The Sustainable eHealth Innovation Chain ....................................................................................... 5
Repeatable Funding Model .............................................................................................................. 6
Connected Health & Wellness Project................................................................................................ 6
Transforming Healthcare into a Sustainable, Person-centred Model ......................... 8
Person-centered Care ............................................................................................................................ 8
Advanced Virtual Care .......................................................................................................................... 8
Shared Principles of Primary Care..................................................................................................... 10
NexJ Connected Wellness .................................................................................................................. 11
NexJ Health Pro ................................................................................................................................... 11
Research Abstracts .......................................................................................................... 13
Cardiovascular Disease Prevention, Management & Rehab ......................................................... 13
Behavior Change for Type 2 Diabetes Management ..................................................................... 14
Cancer Survivorship & Coaching ....................................................................................................... 18
Mental Health Support & Coaching ................................................................................................. 22
Complex High Needs Care Coordination ......................................................................................... 27
References ........................................................................................................................ 29
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NexJ Health’s Dedication to Research and Evidence
Chronic Disease is Healthcare's Greatest Challenge
Chronic disease has become a global epidemic. It is a major contributor to reduced quality of life,
loss of productivity, increased hospitalization and health care costs, and premature death1.
Approximately half of all North Americans have at least one chronic disease, and more than three-
quarters of healthcare spending in North America is on chronic disease management1. According
to the World Economic Forum, Non-Communicable Diseases (NCDs) are the leading cause of
mortality globally, responsible for 71% of all deaths2. The four major NCDs that account for 80%
of all premature deaths are cancer, diabetes, cardiovascular disease and chronic respiratory
diseases2. By addressing modifiable risk factors including healthy behavior changes in diet, and
physical activity, chronic diseases can be largely preventable.
Research Trials & Publications
Peer reviewed clinical trials are the cornerstone of evidence-based care. At NexJ Health, we pride
ourselves in our commitment to quality research that validates the use of our patient facing
population health management platform, NexJ Connected Wellness, to increase adherence to
healthy behaviors, improve clinical outcomes, and better the overall patient experience.
Demonstrated by our partnerships with world class institutions, clinicians and researchers who
deliver programs on NexJ Connected Wellness to large hospitals, and small community-based
facilities.
Evidence suggests that technology alone cannot solve the health crisis, but that it must also take
a human touch. In this regard, we enthusiastically support research into health coaching3–6, which
draws on the principles of positive psychology and the practices of motivational interviewing and
goal setting to facilitate health behavior change7. Adoption of healthy behaviors is critical to
ensure that individuals, those with chronic disease and at risk, maintain a high quality of life. The
research we support demonstrates that health coaching through NexJ Connected Wellness is
effective at improving clinical outcomes for a range of chronic conditions3,4,6,8,9.
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Patient Engagement
At NexJ Health, we believe that the most efficient and cost-effective way to offset the problems
caused by rising rates of chronic disease is to empower patients, with the support of their families,
friends, and healthcare professionals, to actively participate in managing their own chronic
conditions.
NexJ Health defines patient engagement as empowering patients with the knowledge, skills, and
confidence to manage one's own health and wellness. There is compelling evidence connecting
these attributes with improvements in population health and patient experience10 and lower per
capita costs11.
Patient engagement delivers high value for all stakeholders: Patients achieve their health goals.
Payers lower costs. Providers improve care. Pharmaceutical manufacturers and pharmacies
improve medication adherence. And this is all delivered in an efficient, sustainable business model.
The Sustainable eHealth Innovation Chain
The Sustainable eHealth Innovation Chain is a proven process that takes funded input research,
applying it to a market need to create a product that can be then commercialized. This is a
repeatable process that NexJ Health has used to successfully identify core areas where
information technology will have the greatest impact on engaging patients.
As part of the process, NexJ Health donates software and services to get matching research funds.
The project is done in a living lab, where academic and clinical researchers use NexJ Connected
Wellness to deliver an intervention to patients with support from healthcare providers.
The resulting published research provides evidence to the efficacy of the solution with specific
quantitative and qualitative results that are used to further help commercialize the solution. This
process simultaneously provides NexJ Health with valuable product feedback that is used to
further improve the solution.
The resulting published research provides evidence to the efficacy of the solution with specific
quantitative and qualitative results that are used to further help commercialize the solution. This
process simultaneously provides NexJ Health with valuable product feedback that is used to
further improve the solution.
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Repeatable Funding Model
NexJ Health has invested over $30 million in research and development. We have also
helped direct $29 million of government funding to academic partners conducting
research supporting the development and trialing of NexJ Connected Wellness.
Connected Health & Wellness Project
In 2012, the Connected Health and Wellness Project (CHWP) was initiated as a collaboration
between 18 public, private, and academic partners and affiliates who shared a common vision for
the future of healthcare. CHWP's driving premise was that transforming Canada's healthcare
system means rapidly adopting a more person-centered approach to healthcare delivery: one that
is focused on enhancing life-long wellness though improved access to trusted health information,
health coaching and technology advancements that sustain wellness.
The Connected Health & Wellness Project had two goals:
1. To build an educational platform for healthcare professionals that will be foundational for
the emergence of future standards and practice competencies in the health coach
profession, which will integrate NexJ Connected Wellness into practice in health
promotion, disease prevention, and chronic disease management.
2. To create components of NexJ Connected Wellness: a cloudbased solution that enables
patients, their family, friends and healthcare professionals to collaboratively manage
health and wellness through the use of innovative applications and the delivery of
healthcare services.
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At $37M, the Connected Health and Wellness Project was the single largest healthcare project and
the largest project funded by the Federal Economic Development Agency for Southern Ontario
built around a single vision. It is testimony to the strength of this common belief that all partners
(academic, industry, medical) have been able to work in a very compressed 2-year timeframe to
deliver on this ambitious project. New technologies, innovative healthcare practices and creating
self-knowledge about wellness, offer powerful tools for transforming healthcare into a people-
centered and more effective system.
Outcomes of the project included:
Evidence-based research into the effects of health coaching on Type 2 Diabetes and other
chronic diseases using NexJ's innovative health coaching software.
Improvements to NexJ's patient-facing care plans which were co-developed with Beth
Israel Deaconess Medical Center and based on their proven Passport to TRUST program.
An extensive suite of healthy recipes and meal plan videos were developed and accessible
through NexJ Connected Wellness Health Library,
New Basic Certificate Health Coach Training Modules and Advanced Health Coach Training
Modules from York University's Faculty of Health.
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Transforming Healthcare into a Sustainable, Person-centred
Model
Person-centered Care
Person-centered care is about supporting the health and wellbeing of patients by connecting
them with their health information and care team. Doing so encourages collaborative care,
enables patient activation, and drives system efficiency. Ongoing communication between the
care providers and patients helps build a multichannel therapeutic alliance, which is imperative to
encourage healthy behaviors. Technology has the promise to empower individuals and their
families with greater transparency of their healthcare system interactions and to become true
partners with their professional care teams.
NexJ Health's vision is to drive the transformation of healthcare into a sustainable, person-
centered model, where individuals are informed and educated on their condition and treatment
options, and are motivated to take responsibility for their own wellness and engage in positive
health behaviors. In 2009, NexJ Health began partnering with leading academic and clinical
institutions to build an evidence base for the delivery of Advanced Virtual Care on our patient
facing population health management platform, NexJ Connected Wellness, to improve outcomes
for the most prevalent chronic conditions:
Diabetes
Cardiovascular Disease
Cancer
Mental Health
Complex Care
Advanced Virtual Care
Barbara Starfield anchored all subsequent thinking about the essentials of primary care12. She
distilled her ideas into a statement she called the Four Pillars of Primary Care:
First-contact care;
Continuity of care;
Comprehensive care;
Coordination of care.
These Four Pillars are frequently referenced in subsequent work, and specifically laid the
foundation for the Patient-centered Medical Home (PCMH). The PCMH is accountable for meeting
the patient's physical and mental health care needs including prevention and wellness, acute care,
and chronic care. It facilitates partnerships between patients, their family, their physicians and
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other healthcare professionals: an approach to comprehensive primary care characterized by
these Principles13:
Personal Physician (the first-contact, continuous, comprehensive care Pillars);
Whole person orientation (the coordination Pillar);
Physician-directed medical practice;
Coordinated, Integrated care;
Quality and Safety;
Enhanced Access;
Appropriate Payment
The success of the PCMH is foundational to an Integrated Delivery Network (IDN)’s ability to
demonstrate that high quality healthcare can be cost-effective, accessible, and equitable, at a time
when healthcare accountability is significantly increasing. Health information technology to
support patient engagement and activation is essential in enabling the transformation from
volume-to-value as it will support driving better population health outcomes, an improved patient
experience, reduced per capita cost of care, provider and team vitality, and a sustainable business
model.
Bodenheimer et al. (2014) outlined the steps health care organizations and private practicing
clinicians can take to align their practices to the Advanced Primary Care Model14. This framework
provides clear roadmap for the realization of Barbara Starfield’s Primary Care Model15. These 10
building blocks are further enhanced through the use of a patient-facing Virtual Care Platform to
complete the alignment to the Shared Principles of Primary Care16, resulting in the natural
extension of Advanced Primary Care: Advanced Virtual Care.
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Shared Principles of Primary Care
The following are the Shared Principles of Primary Care as identified by the Patient Centered
Primary Care Collaborative, which aim to shift primary care toward a vibrant and sustainable future
better health, better care, and lower costs16. A patient-facing virtual care platform is ideally
leveraged to enhance these principles and the method for doing so is described.
1. Person and Family Centered
Deliver Person and Family-centered Care with a partnership among practitioners, patients, and
their families, ensuring that decisions respect patients’ wants, needs, and preferences, and that
patients have the information and support they need to make decisions and participate in their
own care.
2. Continuous
Establish a patient-team partnership with a multichannel therapeutic alliance that is trusted and
continuous, providing perspective and context throughout all stages of life.
3. Comprehensive and Equitable
Care is comprehensive and equitable with a focus on the "whole person", including prevention
and wellness, behavioral and mental health, acute, chronic, and end-of-life care. Patients are
assessed on their social determinants of health so care delivery can be tailored and personalized
accordingly.
4. Team-based and Collaborative
Provide team-based care where all care providers can practice at the top of their license,
leveraging provider-provider communication, role-based access privileges, and a circle of care
enabling providers to provide collaborative care, centered on the patient.
5. Coordinated and Integrated
Care is coordinated and integrated across all elements of the broader healthcare system, including
specialty care, hospitals, home health care, community services and supports. Care plans that are
written in lay-language and shared with the patient and their family support integrated care
delivery across the continuum, measurably increasing patient activation measures.
6. Accessible
Patients can communicate with their care team through secure messaging, video chat, and
leverage online appointment booking for increased accessibility and reduced wait times.
7. High Value
Patients are assessed and triaged into high-, medium-, and low-touch tiers, so care teams can
provide the right care to each individual based on their condition, treatment, readiness to change,
and personal situation. Population dashboards allow care teams to efficiently manage the low-
touch tiers, so they can spend more time with those in higher touch tiers. The result is high value,
efficient and effective population health management.
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NexJ Connected Wellness
NexJ Connected Wellness is a cloud-based Virtual Care Platform used to deliver patient
engagement throughout the patient journey with these essential elements:
Patient Education
improves understanding of
condition and treatment
for confidence in shared
decision making
Care Coordination enables collaborative,
patient-centered, team-
based care across multiple
care settings
Health Coaching encourages behavior
change to prevent and
manage chronic disease
NexJ Connected Wellness is founded on the latest best practice standards and has been
demonstrated in clinical trials to effectively engage patients with chronic disease to better manage
their health and wellness, contributing to improved patient outcomes and lower costs. Personal
health coaching with a comprehensive, patient-facing solution enables health care professionals
to provide ongoing support to individuals for managing multiple chronic conditions that supports
the full patient journey from preventive health measures to complex care coordination.
Using the NexJ Health Coach mobile app, patients can track and capture their health activities
and measurements. Alternatively, they can automatically capture data by synching to their
personal wearable device (e.g., Fitbit, Garmin), or medical device such as a Bluetooth blood
glucometer and blood pressure cuff, etc. All of this data is added to the patient’s record on NexJ
Connected Wellness, allowing patients capture their behaviors and biometrics and receive
feedback and encouragement from their health coach man. Patients develop a better
understanding of the relationship between their behaviors, biometrics, and how they feel, driving
sustainable behavior change. NexJ Connected Wellness can be used to deliver personal health
coaching programs for mental health, diabetes, hypertension, cancer survivorship, mental
health support, general health and wellness, and more.
NexJ Health Pro
NexJ Health Pro is an iPad app used by healthcare professionals (HCPs) to educate their
patients about their condition and treatment, improving patient understanding and retention.
Health care professionals choose from an expansive portfolio of infographic teaching
presentations designed to make condition and/or treatment conversations highly engaging,
memorable, and actionable. Content is current and developed in collaboration with HCPs,
including key opinion leaders, patient groups, and associations.
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At the point of care, the HCP guides the patient through a presentation, captures audio of the
conversation and adds relevant notes, annotations, images, and test results. The outcome is a
personalized Patient Visit Record (PVR), an exact copy (in video form and as a PDF) of the teaching
presentation that patients can access securely through NexJ Connected Wellness. The patient
can watch the video as often as they wish and share it with their family and friends.
Based on the Passport to TRUST™ program developed at Beth Israel Deaconess Medical Center,
a Harvard Medical School affiliate, patient-friendly care plans are used to support patients through
transitions in care, including post-discharge. Using NexJ Connected Wellness HCPs can create
lay language, patient-facing care plans that are used to communicate to patients and their family
important information on patient's condition, the next steps of their treatment, treatment history
and potential 'what ifs'. Patients can seamlessly share their information and securely
communicate with anyone in their personal circle of care to shift service delivery across multiple
providers and care settings. They can also request appointments, complete assessments and
educational workbooks, and access trusted content through the health library. Population and
participant dashboards enable all stakeholders to better manage ongoing patient wellness.
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Research Abstracts
Cardiovascular Disease Prevention, Management & Rehab
Investigating Improved Self-Management in Uncontrolled Systolic Hypertension
Ritvo, P. & Pirbaglou, M.
Summary
This study investigated the effectiveness of smartphone-assisted health coaching for the control of
hypertension. Smartphone-assisted health coaching with NexJ Connected Wellness will provide self-
monitoring of exercise, diet and stress reduction; provision of timely reminders; photo-journaling of meals;
secure text messaging.
Secondary outcomes will measure self-reported quality of life. 350 men and women between the ages of 25
and 70 with a mean daytime systolic BP >130 mm Hg will be evaluated at Southlake Regional Health Centre,
Newmarket, Ontario.
For more information please visit: https://clinicaltrials.gov/ct2/show/NCT02032719
Heart & Stroke Activate: The Community Hypertension Prevention Initiative
Ross, D.
Summary
This program is the first social impact bond in health in Canada. By providing free health coaching to
participants with prehypertension, along with community supports from the YMCA, Loblaw’s and Shoppers
Drugmart, the aim of this program is to halt the progress to hypertension, and if possible, reverse the increase
in blood pressure. Participants are triaged into one of three coaching intensity tiers, based on their current
engagement in health behaviours, and their readiness to change. Three cohorts will recruit up to 7000
participants in Toronto and Vancouver between 2018 and 2020.
For more information please visit: http://www.heartandstroke.ca/get-healthy/activate
Virtual Care Program
Reid, B., McDonnell, L.,
Summary
The Virtual Care Program is an online system that uses best practices to help you take control of your heart
health. It will help you understand your current health situation and motivate you to manage and improve
the risk factors that impact your health and well-being.
The program is available to people who are at risk for developing heart disease (due to poor lifestyle behaviours
and medical risk factors) and patients who have established heart disease (virtual cardiac rehabilitation
option).
For more information please visit: https://pwc.ottawaheart.ca/programs-services/virtual-care
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Behavior Change for Type 2 Diabetes Management
Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a
Lower-Socioeconomic Status Community: A Randomized Controlled
Trial3
Wayne, N., Perez, D. F., Kaplan, D. M., & Ritvo, P.
Abstract
Background: Adoptions of health behaviors are crucial for maintaining good health after type 2 diabetes
mellitus (T2DM) diagnoses. However, adherence to glucoregulating behaviors like regular exercise and
balanced diet can be challenging, especially for people living in lower-socioeconomic status (SES) communities.
Providing cost-effective interventions that improve self-management is important for improving quality of life
and the sustainability of health care systems.
Objective: To evaluate a health coach intervention with and without the use of mobile phones to support
health behavior change in patients with type 2 diabetes.
Methods: In this randomized controlled trial (RCT), patients from two primary care health centers in Toronto,
Canada, with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c (HbA1c) level of ≥7.3% (56.3
mmol/mol) were randomized to receive 6 months of health coaching with or without mobile phone monitoring
support. We hypothesized that both approaches would result in significant HbA1c reductions, although health
coaching with mobile phone monitoring would result in significantly larger effects. Participants were evaluated
at baseline, 3 months, and 6 months. The primary outcome was the change in HbA1c from baseline to 6
months (difference between and within groups). Other outcomes included weight, waist circumference, body
mass index (BMI), satisfaction with life, depression and anxiety (Hospital Anxiety and Depression Scale [HADS]),
positive and negative affect (Positive and Negative Affect Schedule [PANAS]), and quality of life (Short Form
Health Survey-12 [SF-12]).
Results: A total of 138 patients were randomized and 7 were excluded for a substudy; of the remaining 131,
67 were allocated to the intervention group and 64 to the control group. Primary outcome data were available
for 97 participants (74.0%). While both groups reduced their HbA1c levels, there were no significant between-
group differences in change of HbA1c at 6 months using intention-to-treat (last observation carried forward
[LOCF]) (P=.48) or per-protocol (P=.83) principles. However, the intervention group did achieve an accelerated
HbA1c reduction, leading to a significant between-group difference at 3 months (P=.03). This difference was
reduced at the 6-month follow-up as the control group continued to improve, achieving a reduction of 0.81%
(8.9 mmol/mol) (P=.001) compared with a reduction of 0.84% (9.2 mmol/mol)(P=.001) in the intervention
group. Intervention group participants also had significant decreases in weight (P=.006) and waist
circumference (P=.01) while controls did not. Both groups reported improvements in mood, satisfaction with
life, and quality of life.
Conclusions: Health coaching with and without access to mobile technology appeared to
improve glucoregulation and mental health in a lower-SES, T2DM population. The
accelerated improvement in the mobile phone group suggests the connectivity.
Wayne, N., Perez, D. F., Kaplan, D. M., & Ritvo, P. (2015). Health Coaching Reduces HbA1c in Type 2 Diabetic
Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial. Journal of
Medical Internet Research, 17(10), e224. https://doi.org/10.2196/jmir.4871
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Data mining of a remote behavioural tracking system for type 2 diabetes
patients: results from a randomized controlled trial5
Wayne, N., Cercone, N., Li, J., Zohar, A., Katz, J., Brown, P., & Ritvo, P.
Abstract
Background: Complications from type 2 diabetes mellitus can be prevented when patients perform health
behaviors such as vigorous exercise and glucose-regulated diet. The use of smartphones for tracking such
behaviors has demonstrated success in type 2 diabetes management while generating repositories of
analyzable digital data, which, when better understood, may help improve care. Data mining methods were
used in this study to better understand self-monitoring patterns using smartphone tracking software.
Objective: Associations were evaluated between the smartphone monitoring of health behaviors and HbA1c
reductions in a patient subsample with type 2 diabetes who demonstrated clinically significant benefits after
participation in a randomized controlled trial. Methods: A priori association-rule algorithms, implemented in
the C language, were applied to app-discretized use data involving three primary health behavior trackers
(exercise, diet, and glucose monitoring) from 29 participants who achieved clinically significant HbA1c
reductions. Use was evaluated in relation to improved HbA1c outcomes.
Results: Analyses indicated that nearly a third (9/29, 31%) of participants used a single tracker, half (14/29,
48%) used two primary trackers, and the remainder (6/29, 21%) of the participants used three primary trackers.
Decreases in HbA1c were observed across all groups (0.97-1.95%), but clinically significant reductions were
more likely with use of one or two trackers rather than use of three trackers (OR 0.18, P=.04).
Conclusions: Data mining techniques can reveal relevant coherent behavior patterns useful in guiding future
intervention structure. It appears that focusing on using one or two trackers, in a symbolic function, was more
effective (in this sample) than regular use of all three trackers.
Wayne, N., Cercone, N., Li, J., Zohar, A., Katz, J., Brown, P., & Ritvo, P. (2016). Data mining of a remote
behavioural tracking system for type 2 diabetes patients: results from a randomized controlled trial. Journal
of Medical Internet Research Diabetes, 1(1), 1–14. https://doi.org/10.2196/diabetes.4506
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Participant experiences in a smartphone-based health coaching
intervention for type 2 diabetes: A qualitative inquiry4
Pludwinski, S., Ahmad, F., Wayne, N., & Ritvo, P.
Abstract
Introduction: We investigated the experience of individuals diagnosed with type 2 diabetes mellitus (T2DM)
who participated in an intervention in which the key elements were the provision of a smartphone and self-
monitoring software. The interviews focused on use of a smartphone and the effects on motivation for health
behavior change.
Methods: This was a qualitative evaluation of participants in a larger T2DM self-management randomized
controlled trial (RCT) conducted at the Black Creek Community Health Centre (BCCHC) in Toronto, Canada
(ClinicalTrials.gov Identifier: NCT02036892). The study is based on semi-structured interviews (n¼11) that
were audio taped and analyzed with a thematic analytic approach. The RCT compared the effectiveness of six
months of smartphone-based self-monitoring and health coaching with a control group who received health
coaching without internet or smartphone-based assistance.
Results: Qualitative data analyses resulted in derivation of four major themes that describe participant
experience: (a) ‘smart- phone and software’, describes smartphone use in relation to health behavior change;
(b) ‘health coach’ describes how client/ health coach relationships were assisted by smartphone use; (c) ‘overall
experience’ describes perceptions of the overall intervention; and (d) ‘frustrations in managing chronic
conditions’ describes difficulties with the complexities of T2DM management from a patient perspective.
Discussion: Findings suggest that interventions with T2DM assisted by smartphone software and health
coaches actively engage individuals in improved hemoglobin A1c (HbA1c) control.
Pludwinski, S., Ahmad, F., Wayne, N., & Ritvo, P. (2016). Participant experiences in a smartphone-based
health coaching intervention for type 2 diabetes: A qualitative inquiry. Journal of Telemedicine and Telecare,
22(3), 172–8. https://doi.org/10.1177/1357633X15595178
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Smartphone-enabled health coach intervention for people with diabetes
from a modest socioeconomic strata community: single-arm
longitudinal feasibility study7
Wayne, N., & Ritvo, P.
Abstract
Background: Lower socioeconomic strata (SES) populations have higher chronic disease risks. Smartphone-
based interventions can support adoption of health behaviors that may, in turn, reduce the risks of type 2
diabetes-related complications, overcoming the obstacles that some patients may have with regular clinical
contact (eg, shiftwork, travel difficulties, miscommunication).
Objective: The intent of the study was to develop and test a smartphone-assisted intervention that improves
behavioral management of type 2 diabetes in an ethnically diverse, lower SES population within an urban
community health setting.
Methods: This single-arm pilot study assessed a smartphone application developed with investigator
assistance and delivered by health coaches. Participants were recruited from the Black Creek Community
Health Centre in Toronto and had minimal prior experience with smartphones.
Results: A total of 21 subjects consented and 19 participants completed the 6-month trial; 12 had baseline
glycosylated hemoglobin (HbA1c) levels >7.0% and these subjects demonstrated a mean reduction of 0.43%
(SD 0.63) (P<.05) with minimal changes in medication.
Conclusions: This project supported the feasibility of smartphone-based health coaching for individuals from
lower SES with minimal prior smartphone experience.
Wayne, N., & Ritvo, P. (2014). Smartphone-enabled health coach intervention for people with diabetes from
a modest socioeconomic strata community: single-arm longitudinal feasibility study. Journal of Medical
Internet Research, 16(6), e149. https://doi.org/10.2196/jmir.3180
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Cancer Survivorship & Coaching
Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote
Long-Term Maintenance of Physical Activity in Breast Cancer Survivors:
Protocol for a Feasibility Pilot Randomized Controlled Trial6
Ritvo, P., Obadia, M., Santa Mina, D., Alibhai, S., Sabiston, C., Oh, P., & Jones, J. M
Abstract
Background: Although physical activity has been shown to contribute to long-term disease control and health
in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past
research has focused on promoting physical activity components for short-term breast cancer survivor benefits,
but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are
assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical
activity maintenance in initially inactive breast cancer survivors.
Objective: This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention
and will inform development of a full-scale pragmatic RCT.
Methods: We will enroll 107 physically inactive breast cancer survivors and randomly assign them to
intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto,
Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than
55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment
with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week.
Both intervention and control groups receive the 12-week physical activity program with weekly group sessions
and an individualized, progressive, home-based exercise program. The intervention group will additionally
receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3)
supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting
device linked to a smartphone program.
Results: We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews;
and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The
primary clinical outcome will be directly measured peak oxygen consumption. Secondary clinical outcomes
include health-related quality of life and anthropometric measures. All outcome measures are administered
at baseline, after exercise program (month 3), and 6 months after program (month 9).
Conclusions: This pilot RCT will inform full-scale RCT planning. We will assess pilot procedures and
interventions and collect preliminary effect estimates.
Ritvo, P., Obadia, M., Santa Mina, D., Alibhai, S., Sabiston, C., Oh, P., & Jones, J. M. (2017). Smartphone-
Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in
Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial. Journal of Medical
Internet Research, Research Protocols, 6(8), e165. https://doi.org/10.2196/resprot.6615
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A Phase II RCT and Economic Analysis of Three Exercise Delivery Methods
in Men with Prostate Cancer on Androgen Deprivation Therapy8
Alibhai, S., Santa Mina, D., Ritvo, P., Sabiston, C., Krahn, M., Tomlinson, G., Matthew, A., Segal,
R., Warde, P., Durbano, S., O’Neil, M., & Culos-Reed, N.
Abstract
Background: Androgen deprivation therapy is commonly used to treat prostate cancer, the most common
visceral cancer in men. However, various side effects often worsen physical functioning and reduce well-being
among men on this treatment. Based on existing evidence, both resistance and aerobic training provide
benefits for this population yet adherence rates are often low. The method of exercise delivery (supervised in-
center or home-based) may be important, yet few studies have compared different models. Additionally, long-
term exercise adherence is critical to achieve sustained benefits but long-term adherence data and predictors
of adherence are lacking. The primary aim of this phase II, non-inferiority randomized controlled trial is to
determine whether three exercise training delivery models are equivalent in terms of benefits in quality of life
and physical fitness in this population. Secondary aims include examination of long-term adherence and cost-
effectiveness.
Design: Men diagnosed with prostate cancer, starting or continuing on androgen deprivation therapy for at
least 6 months, fluent in English, and living close to one of two experienced Canadian study centers are eligible.
Participants complete five assessments over one year, including a fitness assessment and self-report
questionnaires. Socio-demographic and clinical data collection occur at baseline, bone mineral density testing
at two time points, and blood work is performed at three time points. Participants are randomized in a 1:1:1
fashion to supervised personal training, supervised group training, or home-based smartphone- and health
coach-supported training. Each participant receives a detailed exercise manual, including illustrations of
exercises and safety precautions. Participants are asked to complete 4 to 5 exercise sessions per week,
incorporating aerobic, resistance and flexibility training. Participant intensity levels will be monitored. The
intervention duration is 6 months, with 6 months additional follow-up. Outcomes include: body composition,
fitness testing, quality of life and fatigue, biological outcomes, and program adherence. Cost information will
be obtained using patient diary-based self-report.
Discussion: The goals of this study are to gain a better understanding of health benefits and costs associated
with commonly used yet currently not compared exercise delivery models as well as an increased
understanding of adherence to exercise.
Alibhai, S., Santa Mina, D., Ritvo, P., Sabiston, C., Krahn, M., Tomlinson, G., Matthew, A., Segal, R., Warde, P.,
Durbano, S., O’Neil, M., & Culos-Reed, N. (2015). A phase II RCT and economic analysis of three exercise
delivery methods in men with prostate cancer on androgen deprivation therapy. BMC Cancer, 15(1), 1–11.
https://doi.org/10.1186/s12885-015-1316-8
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Transforming Community Cancer Care: The Ottawa Regional Cancer
Foundation’s Cancer Coaching Practice17
Eagen, L. & Levesque, J..
Abstract
Community services are an increasingly important part of the healthcare landscape. Services that work to
empower patients and their caregivers are having a positive impact on health outcomes and helping to reduce
per capita costs of healthcare. According to the 2015 Canadian Cancer Statistics Report, by 2030 the annual
number of new cancer cases in Canada is expected to increase by 79% [1]. Community-based cancer services,
in particular, are urgently required to meet the growing demand for care as the complexity of the disease and
its treatment continues to grow.
For more information please visit: http://www.ottawacancer.ca/how-can-we-help-
you/cancer-coaching/cancercoaching
Eagen, L., & Levesque, J. (2017). Transforming Community Cancer Care : The Ottawa Regional Cancer
Foundation’ s Cancer Coaching Practice. University of Ottawa Journal of Medicine, 7(1), 1–3.
Sexual Health and Rehabilitation eClinic (SHAReClinic)
Matthew, A. & Robinson, J. (Princess Margaret Cancer Centre)
Summary
In addressing the need for effective post treatment support for men (and their partners) following treatment
for prostate cancer, the investigators will employ an innovative SHAReClinic (Sexual health and Rehabilitation
eClinic Program) that emphasizes: 1) a bio-medical component (erectile rehabilitation), focused on the long
term return of erectile functioning firm enough for penetration with or without erectile agents/devices; and 2)
a psychological component (intimacy maintenance), involving the maintenance or restoration of couples'
intimacy. Through comparison research, the eClinic will be analyzed and made comparable in quality to the
programs offered currently at leading institutions in major metropolitan areas, thus providing personalized,
comprehensive cancer care to all Canadians.
For more information please visit: https://clinicaltrials.gov/ct2/show/NCT03396848
https://sharec.truenth.ca/
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Peer Navigation
Bender, J. & Kazanjian, A. (Princess Margaret Cancer Centre)
Summary
In this program, men with prostate cancer and/or their partners are matched online with a peer navigator
cancer survivor or caregiver based on criteria that they select (e.g., similar treatment, age, lifestyle, cancer
experience). Peer Navigators are trained to provide their matched peers with personalized one-on-one support
through their care journey with the goal of addressing their support needs, improving coping and reducing
distress. Prostate cancer survivors and caregivers receive training to become peer navigators through a blended
online/in-person, competency-based peer navigator training program. The TrueNTH Peer Navigation Program
is currently being piloted at cancer centres in Toronto and Vancouver. This presentation will provide an
overview of the program and results of the navigator training program.
For more information please visit: https://peernavigation.truenth.ca/
Lifestyle Management
Culos-Reed, N. & Zahavich, A. (University of Calgary)
Summary
Provides men with prostate cancer the ability to enhance health and wellness through access to local and
online physical activity, healthy eating and mindfulness programs and resources through NexJ Connected
Wellness.
For more information please visit: https://lifestyle.truenth.ca/
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Mental Health Support & Coaching
Smartphone-enabled Health Coaching Intervention for Youth Diagnosed
With Major Depressive Disorders9
Ritvo, P. Ritvo, Paul & Daskalakis, Zafiris & Tomlinson, George & Ravindran, Arun & Linklater,
Renee & Kirk Chang, Megan & Knyahnytska, Yuliya & Lee, Jonathan & Alavi, Nazinan & Bai, Shari & Harber,
Lillian & Jain, Tania & Katz, Joel. (2018).
Summary
A high proportion (70%) of mental health problems appear before 25 yrs. and can become become long-
standing, significant disorders that impair all life domains. Early signs of disorder left untreated is an acute
problem for Canadian youth as 15-25 yrs is the most likely age-strata for diagnosable psychiatric disorders,
substance dependencies and suicide. Progress in youth treatments that engage the tendencies of youth to
respond to online internet contact are likely to be especially strategic.
In this randomized controlled trial (RCT) diagnosed depressed youth are treated with online mindfulness-based
cognitive behavioural therapy (MB-CBT) and standard psychiatric care or just standard psychiatric care (as
wait-list controls). Eligible subjects will be recruited from the wait-lists of the Centre for Addiction and Mental
Health (CAMH), and from community-based practices and clinics proximal to CAMH. The consented 168
subjects will be from First Nations background (18-30 yrs) and from all other ethnic backgrounds, stratified
into two intervention groups and two wait-list control groups.
Primary outcome is self reported depression using the Beck Depression Inventory II while secondary outcomes
include self reported anxiety (Beck Anxiety Inventory), depression (Quick Inventory of Depressive
Symptomatology, 24-item Hamilton Rating Scale for Depression (HRSD-24)), pain (Brief Pain Inventory)
mindfulness (Five-Facet Mindfulness Questionnaire) and intervention costs.
If hypotheses are confirmed that youth can be effectively treated with online MB-CBT at reduced costs, effective
treatment can be delivered to greater numbers with less geographic restriction.
Ritvo P, Daskalakis Z, Tomlinson G, et al. A smartphone-online intervention for youth diagnosed with major
depressive disorders: Protocol for a randomized controlled trial. (Preprint). JMIR Res Protoc. July 2018.
doi:10.2196/11591
For more information please visit: https://clinicaltrials.gov/ct2/show/NCT03406052
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Online Young Adult Peer Support at a Youth Mental Health Drop in Centre
Wiljer, D. (Stella’s Place/University Health Network)
Summary
This initiative addresses the need for innovative technology solutions for young adults struggling with mental
health issues. NexJ Connected Wellness is a platform to support education, collaboration, engagement,
intervention and goal-focused coaching, accessible via an app or desktop computer. The platform is
customized to be tested for use by young adults with mental health challenges, having already been tested
(health outcomes/performance) by adults with chronic health conditions. Additional content/capabilities will
be developed, implemented and evaluated including mental health educational materials, on-line
interventions, trackers and peer coaching supports to address the specific needs of young adults.
Reconnect Community Health Services will oversee implementation of the platform at two health care settings:
Stella’s Place (Toronto), the Youth Wellness Centre (St Joseph’s Healthcare, Hamilton). Clinical and peer
support personnel will be trained to deliver care and coaching using the platform. The project includes pre-
market evaluation of the platform with respect to user experience and outcomes, engagement, platform
functionality and efficiency. The research protocols and evaluation will be developed and implemented under
the direction of a Health Innovation Team and a co-design team which includes young adults with lived
experience, academic researchers, clinical practice and informatics experts and health economists.
A market-ready product will be developed with accompanying knowledge sharing and procurement
specifications, identifying the efficacy, clinical utility, cost effectiveness and safety of the platform, as well as
documented experiences of young adults, peer coaches and clinicians in supporting the self-management of
young people with mental health challenges using platform.
For more information please visit: http://www.oce-ontario.org/news-events/news/2017/11/09/new-
digital-platform-for-mental-health-support-demonstrated-at-stella-s-place
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Perfectionism Anxiety and Depressive Distress: Evidence for the
Mediating Role of Negative Automatic Thoughts and Anxiety Sensitivity18
Pirbaglou, M., Cribbie, R., Irvine, J., Radhu, N., Vora, K., & Ritvo, P.
Abstract
Objective: This study assessed a mediational model in which negative automatic thoughts and anxiety
sensitivity were hypothesized to mediate the relationship between perfectionism cognitions and depressive
and anxiety symptoms.
Participants: Participants were undergraduate students from an urban Canadian university. The data were
collected from July 2009 to August 2010.
Methods: In a cross-sectional evaluation, 992 undergraduate participants completed questionnaires that
assessed perfectionism cognitions, negative automatic thinking, anxiety sensitivity, and anxiety and depressive
symptoms.
Results: Mediational analysis confirmed the role of anxiety sensitivity and negative automatic thoughts in
mediating the association between perfectionistic cognitions, anxiety symptoms, and depressive distress.
Furthermore, in line with previous studies, nearly a third of students displayed an elevated prevalence of
anxiety and depressive symptoms.
Conclusions: This study further clarified the associations and mediating relationships among mood states
associated with perfectionism.
Pirbaglou, M., Cribbie, R., Irvine, J., Radhu, N., Vora, K., & Ritvo, P. (2013). Perfectionism, anxiety and
depressive distress: evidence for the mediating role of negative automatic thoughts and anxiety sensitivity.
Journal of American College Health, 61(8), 477-483. https://doi.org/10.1080/07448481.2013.833932
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Cognitive Behavioral Therapy-related Increases in Cortical Inhibition in
Problematic Perfectionists19
Radhu, N., Daskalakis, Z., Guglietti, C., Farzan, F., Barr, M., Arpin-Cribbie, C., Fitzgerald, P., &
Ritvo, P.
Abstract
Background: Several lines of evidence suggest that cognitive behavioral therapy (CBT) is an effective
treatment for depression and anxiety disorders. Evidence suggests that the therapeutic effects of CBT are
related to neurophysiologic changes in the cortex, particularly γ-aminobutyric acid (GABA) potentiation.
Transcranial magnetic stimulation (TMS) represents a noninvasive method of measuring cortical inhibition,
which is a neurophysiologic mechanism associated with the pathophysiology of several psychiatric disorders.
Objective/Hypothesis: To demonstrate the effectiveness of a 12-week CBT intervention compared with a wait
list control group measuring cortical inhibition in participants with pathologic perfectionism. Participants
within the CBT group would demonstrate increases in cortical inhibition and improvements on clinical
outcomes relative to the wait list control group.
Methods: Twenty-four right-handed perfectionists were randomly assigned to a 12-week CBT intervention or
a wait list control group. Cortical inhibition was measured at pre- and postintervention with TMS paradigms
specifically short-interval cortical inhibition and the cortical silent period, which index GABAA and GABAB
receptor-mediated inhibitory neurotransmission, respectively.
Results: The CBT group demonstrated a significant potentiation of the cortical silent period when compared
with the wait list control group. The CBT group demonstrated a decrease in anxiety sensitivity and automatic
thoughts relative to the control group.
Conclusions: These findings demonstrate that CBT tailored for perfectionism is accompanied by an increase
in cortical inhibition of the motor cortex and positive changes on clinical outcomes. These findings provide
compelling evidence for an association between positive CBT effects and a potentiation of GABAergic inhibitory
neurotransmission.
Radhu, N., Daskalakis, Z., Guglietti, C., Farzan, F., Barr, M., Arpin-Cribbie, C., Fitzgerald, P., & Ritvo, P. (2012).
Cognitive behavioural therapy-related increases in cortical inhibition in problematic perfectionists. Brain
Stimulation, 5(1), 44-54. https://doi.org/10.1016/j.brs.2011.01.006
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Evaluating a Web-based Cognitive-behavioral Therapy for Maladaptive
Perfectionism in University Students20
Radhu, N., Daskalakis, Z., Arpin-Cribbie, C., Irvine, J., & Ritvo, P.
Abstract
Objective: This study assessed a Web-based cognitive-behavioral therapy (CBT) for maladaptive
perfectionism, investigating perfectionism, anxiety, depression, negative automatic thoughts, and perceived
stress.
Participants: Participants were undergraduate students defined as maladaptive perfectionists through a
screening questionnaire at an urban university. The data were collected from July 2009 to August 2010.
Methods: Forty-seven maladaptive perfectionists were randomly assigned to a 12-week CBT or a wait-list
control group and assessed via questionnaires at pre- and post- intervention. Statistical procedures included t
tests, Pearson correlations, and analysis of covariance.
Results: At the post intervention measure, the CBT group demonstrated significant decreases in anxiety
sensitivity and negative automatic thoughts compared to the control group. Within the CBT group, changes
in perfectionism scores were significantly correlated with positive changes in depression, anxiety, stress, and
automatic thoughts.
Conclusions: the treatment group improved on psychological outcomes, demonstrating the effectiveness of a
Web-based CBT for perfectionism in a university setting.
Radhu, N., Daskalakis, Z., Arpin-Cribbie, C., Irvine, J., & Ritvo, P. (2012). Evaluating a Web-based cognitive-
behavioral therapy for maladaptive perfectionism in university students. Journal of American College Health,
60(5), 357-366. https://doi.org/10.1080/07448481.2011.630703
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Complex High Needs Care Coordination
Patient-facing Virtual Care for Paediatric Complex Care
Orkin, J. & Stinson, Adams, S., & J. (Sick Children’s Hospital)
Summary
This initiative addresses the need for innovative technology solutions for maternal and child health,
particularly for children with medical complexity (CMC) – children with medical fragility and technology
dependence – and their families and caregivers.
NexJ Connected Wellness, a patient-facing virtual care platform, will enable care coordination for CMC and
their families by providing access to a patient-facing coordinated care plan, patient health record, secure
information sharing, online scheduling and questionnaires, and secure communication with their healthcare
team. The program will enable remote access to critical information for all care providers, linking the
community, acute care, and rehabilitation centres to establish a shared care plan.
The Hospital for Sick Children (SickKids) and the Complex Care Kids Ontario Strategy lead by the Provincial
Council for Maternal Child Health (PCMCH) will oversee the implementation of the platform at three
healthcare settings: SickKids and two of its satellite clinics: Credit Valley Hospital, and Royal Victoria Hospital,
in order to demonstrate a paediatric regional healthcare model.
The project includes pre-market evaluation of the platform, including user experience and outcomes,
engagement, platform functionality and efficiency, using a user-centre design approach. Research protocols
and evaluation will be developed and implemented under the direction of the health innovation team.
A market-ready product will be developed and accompanying knowledge sharing and procurement
specifications, identifying the efficacy, clinical utility, cost effectiveness and safety of the platform, with
qualitative feedback from the participating patients, families and clinicians on their experience in using a
digital technology to support maternal and child health.
For more information please visit: https://www.nexjhealth.com/press-room/press-releases/sickkids-nexj-
health-funded-patient-facing-paediatric-complex-care/
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Improving doctor-patient communication in the outpatient setting using
a facilitation tool: A preliminary study21
Neeman, N., Isaac, T., Leveille, S., Dimonda, C., Shin, J. Y., Aronson, M. D., & Freedman, S. D.
Abstract
Quality problem: Patients often do not fully understand medical information discussed during office visits.
This can result in lack of adherence to recommended treatment plans and poorer health outcomes.
Choice of solution: We developed and implemented a program utilizing an encounter form, which provides
structure to the medical interaction and facilitates bidirectional communication and informed decision-
making.
Implementation: We conducted a prospective quality improvement intervention at a large tertiary-care
academic medical center utilizing the encounter form and studied the effect on patient satisfaction,
understanding and confidence in communi- cating with physicians. The intervention included 108 patients
seen by seven physicians in five sub-specialties.
Evaluation: Ninety-eight percent of patients were extremely satisfied (77%) or somewhat satisfied (21%) with
the program. Ninety-six percent of patients reported being involved in decisions about their care and
treatments as well as high levels of understanding of medical information that was discussed during visit.
Sixty-nine percent of patients reported that they shared the encounter form with their families and friends.
Patients’ self-confidence in communicating with their doctors increased from a score of 8.1 to 8.7 post-
intervention (P-value ¼ 0.0018). When comparing pre- and post-intervention experiences, only 38% of
patients felt that their problems and questions were adequately addressed by other physicians’ pre-
intervention, compared with 94% post-intervention.
Lessons learned: We introduced a program to enhance physician–patient communication and found that
patients were highly satisfied, more informed and more actively involved in their care. This approach may be
an easily generalizable approach to improving physician–patient communication at outpatient visits.
Neeman, N., Isaac, T., Leveille, S., Dimonda, C., Shin, J. Y., Aronson, M. D., & Freedman, S. D. (2012). Improving
doctor-patient communication in the outpatient setting using a facilitation tool: A preliminary study.
International Journal for Quality in Health Care, 24(4), 357–364. https://doi.org/10.1093/intqhc/mzr081
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19. Radhu N, Daskalakis ZJ, Guglietti CL, et al. Cognitive behavioral therapy-related increases in cortical inhibition in problematic perfectionists. Brain Stimul. 2012;5(1):44-54. doi:10.1016/j.brs.2011.01.006
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21. Neeman N, Isaac T, Leveille S, et al. Improving doctor-patient communication in the outpatient setting using a facilitation tool: A preliminary study. Int J Qual Heal Care. 2012;24(4):357-364. doi:10.1093/intqhc/mzr081
www.nexjhealth.com
NexJ Health Inc is a provider of cloud-based population health
management solutions delivering patient engagement for chronic disease
management.
For more information, please contact:
Dr. Noah Wayne, PhD
Director, Clinical Programs
©2019 NexJ Health Inc.
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