planning the “activity and nutrition trial in lupus to ... · planning the “activity and...
TRANSCRIPT
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Planning the “Activity and Nutrition Trial in Lupus to
Energize and Renew” (ANTLER Study)
Linda Ehrlich-Jones, PhD, RN March 26, 2015
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Disclosures
Funding from: NIH-NIAMS U34-AR064513 NIH-NIAMS R21-AR059989 NIH-NIAMS T32-AR007611 Northwestern University Dean’s Office Seed
Grant
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Objectives
1) Describe the planning process for a clinical trial.
2) Discuss lessons learned through pilot testing an intervention.
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Introduction Systemic Lupus Erythematosus (SLE) is a
chronic, systemic, autoimmune disease characterized by pronounced inflammation that affects up to 1.5 million persons in the US.
More common in: – Women (9:1) – African-American, Hispanic, and Asian
populations
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ACR Image Bank
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Introduction Most organ systems can be involved. While excess mortality has decreased, a major
ongoing cause of morbidity is chronic, debilitating fatigue.
Fatigue leads to decrease in quality of life, increase risk of work disability, and associated health care costs.
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Introduction An unmet need in the management of patients
with SLE is identification of effective strategies to decrease fatigue.
Physical activity and dietary intake are modifiable behaviors considered potentially relevant to reducing fatigue in patients with SLE.
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Activity in Lupus to Energize and Renew (ALTER)
R21: cross-sectional study of 129 adults with SLE
Primary outcome was Fatigue measured by the Fatigue Severity Scale (FSS)
Secondary outcome included physical activity measured by tri-axial accelerometers worn for 7 days
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ALTER Fatigue
0
1
2
3
4
5
6
7Fatigue Severity Scale
≥ 4 clinically significant
level of fatigue
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ALTER Participants and Public Health Physical Activities Guidelines (n=129)
Inactive, 44%
Low active, 43%
Active , 13%
Very active, 4%
SLE patients are sedentary
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ANTLER Pilot 1 6-week behavioral intervention consisting of individual
tailored coaching and three group educational sessions to promote physical activity and increased consumption of fruits and vegetables in persons with SLE
Motivational interviewing used in coaching sessions that led to goal setting for physical activity and diet changes
8 participants started and 7 completed 6 Women and 2 Men 4 AA, 2 Asian, 2 Caucasian
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Measuring Physical Activity
Participants wore triaxial accelerometer at natural waistline during waking hours for 7 days.
They kept a log as to when they put on and took off.
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Accelerometer Data Uniaxial
Triaxial
z axis
Vector Magnitude
x axis
y axis
y axis
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Measuring Diet
ASA24™ Announcements
• Dietary Assessment Primer
• ASA24-Canada-2014 was released! Quick Links
• Respondent Web Site Demonstration (ASA24-2014 and ASA24-Kids-2014)
• Respondent Web Site Demonstration (ASA24-2011 and ASA24-Kids-2012)
• Researcher Web Site
• Join the ASA24 Listserv
ASA24 is a freely available Web-based tool that enables automated self-administered 24-hour recalls. ASA24 consists of a Respondent Web site used to collect recall data and a Researcher Web site used to manage study logistics and obtain data analyses. Two US Respondent Web sites (English and Spanish) are currently available for registering new studies: ASA24-2014 (for adults) and ASA24-Kids-2014. One Canadian version, ASA24-Canada-2014 (English only) is currently available for administration and the ability to obtain analyses for this will be available soon. Still available until March of 2015 are two previous versions of the Respondent Web site:ASA24-2011 (for adults) and ASA24-Kids-2012. Further information on the Respondent and Researcher Web sites is provided in the sections below.
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Lesson Learned From ANTLER Pilot 1 Intervention well received
– Individual sessions: liked 1-on-1 and goal setting – Group sessions: felt they learned a lot from other participants,
wanted more time to interact with other participants, wanted website portal to continue interaction outside of group
Assessments completed online on Assessment Center and ASA-24 – Assessment Center worked well to measure all PRO’s – ASA-24 too labor intensive
Missed data capture
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Planning for the Clinical Trial NIAMS U34 Planning Cooperative Agreement for investigator-
initiated clinical interventional trials Designed to permit the necessary planning, design, and
preparation of documentation prior to investigator-initiated clinical trials.
Completion of U34 planning grant milestones is recommended prior to submission of a clinical trial through a U01 mechanism.
Trials must be hypothesis-driven, milestone-defined, related to the research mission of the NIAMS and considered high priority by the Institute.
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Other Institutes currently offering U34 NIDDK NIDCD
New mechanism: R34
– NIAID – NIDCR – NIA
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1) Develop protocol for U01 application 2) Revise behavioral interventions from IMPAACT, JointADventure, and ANTLER pilot 3) Develop protocol for control arm (focus on education not behavior change) 4) Submit U01 application for ANTLER 5) Develop manual of operations (MOP), forms and data systems, smartphone application, training and educational materials 6) Prepare Human Subjects Protection Documents and Develop Data Safety Monitoring Plan
U34 Specific Aims:
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Innovation Emphasis on increasing physical activity in conjunction with
modifying dietary intake using an intensive motivational interviewing (MI) behavioral intervention strategy
Use of state-of-the-art approaches to assess physical activity and patient reported outcomes (PROs) in patients with SLE
Assessment of dietary intake to evaluate both nutrient content and energy density which may offer new insights regarding potential contributors to fatigue in this population
Use of state-of-the-art technology for communication strategies and self-monitoring of behavior change in patients with SLE
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ANTLER Research Team Organization Chart
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Half Day Retreat Brainstorming with entire U34 team Felt the need to perform ANTLER Pilot 2 to
test – smartphone application and coaching
interface, – wearing of accelerometer 24 hours per day
for 7 days to assess sleep, – Nutrition Data System for Research (NDSR)
diet interview
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ANTLER Pilot 2 6-week intervention using Fitbit and ANTLER
Smartphone apps and coaching interface – Self-monitoring physical activity, fruit/vegetable
consumption, sleep quantity and quality Motivational Interviewing with goal setting 6 participants: 5 Women, 1 Man 4 AA, 1 Hispanic, 1 Caucasian 3+ participated in ANTLER Pilot 1
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ANTLER Pilot 2 Motivational Interviewing
– Arthritis Comprehensive Treatment Assessment adapted for SLE
– Coaching per phone and/or email Smartphone app and coaching interface Fitbit
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Antler Pilot 2: Demographics
N %Race
Caucasian 1 16.67African American 4 66.67
Hispanic 1 16.67
N %Sex
Female 5 83.33
N %Marital Status
Single 1 16.67Married 3 50
Divorced 2 33.33
N %Weight Status
Normal Weight: <25 1 16.67Over Weight: >=25 or <30 2 33.33
Obese: >=30 3 50
N Mean Std Dev Minimum Median MaximumAge at time of visit 6 51.66 13.02 31.49 52.39 71.12
Disease Duration 6 13.48 7.62 2.92 18.16 18.83WEIGHT 6 191.05 47.72 135.5 180.8 251HEIGHT 6 66.53 2.91 64.27 65.95 72.1
BMI 6 30.15 6.35 23.04 29.52 39.9BP Diastolic 6 78.83 12.35 61 80 94BP Systolic 6 123.5 8.22 113 123 137Waist (cm) 6 100.75 13.48 87 99.75 118.5
Hip (cm) 6 110.25 10.9 95.5 109.5 125Waist/Hip Ratio 6 0.91 0.08 0.84 0.9 1.06
Years of Education Completed 6 14.67 2.16 12 15.5 17
BASELINE PATIENT CHARACTERISTICS
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ANTLER Smartphone App and Fitbit
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Coaching Interface
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Daily Steps (Fitbit)
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Very Active Minutes (Fitbit)
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Accelerometry Data
Subject
Average Vector
Magnitude Baseline
Average Vector
Magnitude 6 wk Difference
2 377387 280984 -964034 917080 996982 79901.85 411287 319641 -916467 586171 296459 -28971110 410956 . .11 722006 576733 -145273
Subject
Average Light
Activity Baseline
Average Light
Activity 6 wk Difference
2 385 316.25 -68.754 430 370.14 -59.865 258.86 208 -50.867 425.57 255 -170.5710 364.29 . .11 386.14 382.38 -3.77
Subject
Average Mod/Vig Activity Baseline
Average Mod/Vig Activity
6 wk Difference2 13.14 7.38 -5.774 93.57 110.71 17.145 42.57 30.63 -11.957 50 14.5 -35.510 18.57 . .11 78.86 46.88 -31.98
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ANTLER Pilot 2 NDSR
(n=6) Mean Std Dev Median Mean Std Dev Median
2231.66 1389.17 1848.52 Total Energy (kcal) 1647.43 1222.99 1207.0287.96 51.57 89.69 Total Fat (g) 48.4 24 43.4834.26 9.61 33.08 % Calories From Fat 30.89 12.64 30.81
268.07 187.51 219.22 Total Carb (g) 203.48 136.79 160.746.25 11.09 46.49 % Calories From Carbohydrate 47.95 7.01 47.4388.48 32.45 76.66 Total Protein (g) 79.41 76.88 58.82
18.2 6.95 18.11 % Calories From Protein 18.31 7.49 15.158.69 18.82 58.1 Animal Protein (g) 58.99 66.23 37.9829.79 17.49 28.78 Vegetable Protein (g) 20.42 12.07 16.28
9.4 22.97 0 Alcohol (g) 15.45 37.75 0.021.34 3.26 0 % Calories From Alcohol 2.8 6.79 0.03
26.84 18.05 22.43 Total SFA (g) 18.89 11.28 16.2410.22 2.31 9.86 % Calories From SFA 12.43 7.85 11.7234.32 20.07 35.68 Total MUFA (g) 16.26 8.66 14.6113.74 6.4 12.71 % Calories From MUFA 9.82 2.75 10.5120.19 12.53 18.96 Total PUFA (g) 8.78 3.85 8.95
7.81 2.52 6.93 % Calories From PUFA 5.85 2.98 5.2619.67 12.44 21.63 Total Dietary Fiber (g) 18.65 8.81 16.18
920.58 561.61 890.1 Calcium (mg) 607.66 258.37 519.85430.65 261.27 382.34 Magnesium (mg) 315.02 238.3 245.63
2670.36 2265.16 1693 Sodium (mg) 1866.46 1626.12 1386.032597.96 1131.07 2616.72 Potassium (mg) 2127.72 1861.45 1402.45
1.59 1.38 0.92 Omega-3 Fatty Acids (g) 0.91 0.73 0.53100.19 102.84 73.71 Added Sugars (by available carb) (g) 56.12 50.36 55.81248.03 187.24 203.41 Available Carbohydrate 184.63 131.6 149.25
94.44 95.57 70.06 Added Sugars (by total sugars) (g) 45.63 45.84 28.37
BASELINE NUTRIENT FOLLOW-UP
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Lessons Learned from ANTLER Pilot 2 Fitbit app and ANTLER app confusion Not all Smartphones were compatible Charging Fitbit-need computer or external charger Loss of Fitbit Fitbit/Actigraph sleep issues Other self-monitoring goals: water, calories
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Preliminary Specific Aims for U01
Test the effectiveness of the ANTLER intervention for SLE to decrease fatigue, the primary outcome.
Test the effectiveness of the ANTLER intervention for SLE to improve PA and diet behavior, the secondary outcomes.
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Original Preliminary Trial Design 12 month active arm (intervention)
– Baseline individual counseling session – 3 months of biweekly intensive lifestyle group counseling and 6
months of monthly lifestyle group counseling – 4 additional individual counseling sessions at 6 weeks, 3
months, 6 months, and 11 months. 12 month comparator arm (control)
– Details TBD but focus is on education, will include individual and group sessions
– But will NOT include healthy lifestyle counseling or motivational interviewing
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Proposed Study Designs- 6 month intervention, continue self-monitoring, and 6
month follow up Experimental vs Standard of Care
– Experimental: Group sessions, individual sessions, self-monitoring
– Standard of Care: Education on living with SLE Factorial Design:
– Group only; Group and individual sessions; Group and self-monitoring; Group, individual sessions and self-monitoring
Step-Up Approach: – Group; add individual sessions; add self-monitoring
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Concept Variable Measure Data Collection
Background Variables
Demographics
Age, gender, race, marital status, education Level
Chicago Lupus Database protocol
Online questionnaire via Assessment Center
Current Health Disease activity, damage
*SLEDAI, ACR/SLICC-DI
Face to face interview, MD history and examination
Disease duration, medications, co-morbid conditions including fibromyalgia, anemia, hypothyroidism
Chicago Lupus Database protocol
Face to face interview, MD history, examination (fibromyalgia)
*SLEDAI= Systemic Lupus Erythematosus Disease Activity Index; SLICC/ACR-DI= Systemic Lupus International Collaborating Clinics/American College of Rheumatology-Damage Index
Data Collection for ANTLER [Guided by Cox’s Interaction Model of Client Health Behavior]
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Concept Variable Measure Data Collection Mediating Variables
Motivation Motivation Motives for Physical Activity Measure-Revised (MPAM-R); Food Choice Questionnaire (FCQ)
Self-report: Online questionnaires via Assessment Center
Health Behaviors
Physical Activity Physical activity Accelerometer counts/day; Minutes of non-sedentary activity/day; Minutes of moderate-vigorous physical activity/day ; International Physical Activity Questionnaire (IPAQ)
Actigraph accelerometry (sleep) Online questionnaire via Assessment Center
Diet Behavior 24 hour dietary recall NDSR not ASA24 Self-report: Online questionnaire
Data Collection for ANTLER
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Concept Variable Measure Data Collection Health Outcomes
Physical Function Physical Function Timed 20 meter walk test In-person clinical assessment
Blood pressure and anthropometric measurements
BP, height, weight, waist-hip ratio
*MESA Protocol In person clinical assessment
Patient-reported outcomes
Fatigue Fatigue Severity Score (FSS); PROMIS-Short Form
Self-report: Online questionnaire via Assessment Center
Pain PROMIS-Short Form Self-report: Online questionnaire via Assessment Center
Depression PROMIS-Short Form Self-report: Online questionnaire via Assessment Center
Anxiety PROMIS-Short Form Self-report: Online questionnaire via Assessment Center
Sleep Disturbance PROMIS-Short Form Self-report: Online questionnaire via Assessment Center
Sleep-Related Impairment
PROMIS-Short Form Self-report: Online questionnaire via Assessment Center
Physical Function PROMIS-Short Form Self-report: Online questionnaire via Assessment Center
*MESA= Multi-Ethnic Study of Atherosclerosis
Data collection for ANTLER
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Outcomes Less Fatigue—FSS (primary) Improved QoL– PROs, e.g. PROMIS pain, fatigue, anxiety,
depression, sleep disturbance and interference – Measure sleep, actigraph, other tools? – PROMIS-short forms or CATS
Less Sedentary – physical activity--accelerometer (objective) and IPAQ (subjective) – physical function--gait speed (objective) and PF from PROMIS
(subjective) Improved Nutrition—NDSR- what change is significant? Other?? -bio-specimens for mechanistic studies; health utility
and work status
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Acknowledgements: Study Participants
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Cores Members Goals Leadership core Rosalind Ramsey-
Goldman and Linda Ehrlich-Jones
Oversee planning activities; prepare U01 application
Methodology/Data Management Core
Joan Chmiel and Rowland Chang; Anh Chung, Irene Helenowski, Dan Erickson, Madeleine Ma
Oversee study design, power, data analysis, data management, data security
Patient Reported Outcomes (PROs)
Susan Yount, Mary Mahieu; Anh Chung, Dan Erickson
Expertise in PROs; support for assessment center
Research Support Karen Mancera-Cuevas: Patricia Murphy, Danielle Lerner, Liliana Medina
Manage day to day operations of trial; regulatory; recruitment; training of staff; group activities
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Cores Members Goals Physical Activity Measurement and Development
Dorothy Dunlop and Pamela Semanik; Jing Song
Oversee physical activity assessments objective and subjective; manage data and input on intervention and interpretation of data
Nutrition Measurement and Intervention Development
Linda Van Horn; Eileen Vincent, Liliana Medina, Mary Mahieu
Oversee selection and data collection of diet quality and quantity; input on intervention; biomarkers
Behavior Assessment and Intervention Development
Bonnie Spring and Christine Pellegrini; Gleb Iakovlev, Miriam Davidson
Develop behavioral treatment and control education arms; Motivational interviewing training; oversee technology tools
New areas: sleep assessment/light exposure/depression
Phyllis Zee, Kathy Reid, and Kathy Wisner
Incorporate objective sleep assessments, light intervention; coordinate with PRO data
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Thank You
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Group Sessions
Experimental monthly group sessions (10 people per group): – 1: Intro to program and technology – 2: physical activity/safety – 3: fruit/vegetable volumetrics – 4: sleep/fatigue – 5: motivation – 6: eating outside the home
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Group Sessions Standard of Care monthly group sessions (10 people per
group): – 1: Intro to program and technology in a group – 2: How do I know if I have SLE? – 3: How do I know if what I feel is SLE? – 4: What should I tell my other doctors about my SLE? – 5: What community resources are there for people with SLE? – 6. What do I need to know to live with SLE?
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Individual Sessions Experimental Group
Check in with coach regarding technology 2-3 days after group session on technology
Initial coaching session 1 week later for ACTA and goal setting 1st month every other week call with coach Individual sessions by text, email or phone thereafter
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Individual Sessions Standard of Care Group
Check in with coach regarding technology 2-3 days after group session on technology
Bi-weekly text messages regarding self-management
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Self-monitoring Standard of Care Group Self-monitoring of SLE symptoms Smartphone app from Lupus Initiative
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Self-monitoring Experimental Group Self-monitoring of physical activity, consumption of fruits
and vegetables, sleep/fatigue Smartphone app(s) Fitbit and ANTLER
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Preliminary Studies and Retreat Action Items
ALTER study-reviewed at retreat 7/2/14 – physical activity assessment and patient reported outcomes
ANTLER pilot I-reviewed at retreat 7/2/14 – short term intervention feasibility study with group and
individual coaching sessions ANTLER pilot II-action item from retreat 7/2/14
– Short term intervention to test feasibility of self monitoring – Test another dietary assessment tool
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Summary from ALTER
Self-reported International Physical Activity Questionnaire (IPAQ) showed modest associations with accelerometer measures in adults with SLE (Ahn GE et al Arthritis Care Res (Hoboken). 2014 Sep 23. doi: 10.1002/acr.22480. [Epub ahead of print])
Self-reported IPAQ and objective accelerometer data may be useful for
different purposes in future research studies – IPAQ provides descriptive data on the types of PA performed – Accelerometer data may be useful when a change in PA is the
outcome of interest in intervention studies (same as above)
Modest negative correlations were seen between fatigue, pain, and physical activity – First report of PROMIS data results and internal consistency of domains in
adult SLE (Mahieu M et al, submitted for Arthritis Care & Res (Hoboken) for themed issue on fatigue in rheumatic diseases)
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Rationale for Study Fatigue is most disabling and enduring complaint among
patients with SLE along disease continuum Fatigue is a major problem for SLE patients and it is not
consistently associated with disease activity, disease damage, or medications
To date there are limited treatment options for fatigue Physical activity and dietary intake are modifiable
behaviors considered potentially relevant to reducing fatigue in patients with SLE
We propose to design an intensive lifestyle behavior counseling program modeled after Diabetes Prevention Program (DPP) to reduce fatigue in patients with SLE
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Site Quality Management Plan
Training – Active intervention (includes motivational interviewing) – Control intervention (education; no behavioral or lifestyle
content) Treatment fidelity Data management and security
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Timing of Assessments 4 assessment times:
– T0: Baseline – T1: 3 months post randomization – T2: 6 months post randomization – T3: 12 months post randomization