Facilitating Medication Adherence & Eliminating Therapeutic Inertia Using

Wireless Technology: Proof of Concept Findings with Uncontrolled Hypertensives &

Kidney Transplant Patients

SubtitlePresenters

Date

John W McGillicuddy, MD,Mathew Gregoski, PhD. ,Brenda Brunner

Jackson, MPH, Ana Weiland, BS, Sachin Patel, MS, Rebecca Rock, Eveline Treiber, Lydia

Davidson & Frank Treiber, PhD. Presented: Wireless Health 2012 ; San Diego, Ca. ,10/24/12

Background What unmet healthcare needs are we addressing? Effective programs for chronic disease management:

• Patient non-adherence to medication regimens • Therapeutic inertia(failure to respond in timely

manner to clinical data) What is take away message ? Theory based, patient & provider guided, SOC validated, mHealth self management programs are viable solutions

BackgroundMedication adherence: extent prescribed dose,Frequency, & timing of regimen followed 50% of patients adhere to medication regimens

Med non-adherence leads to: Suboptimal clinical outcomes Reduced work force productivity Increased healthcare costs $100-300 Billion/yr

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Background mHealth Viable Solution

~ 20,000 chronic disease management & health /wellness apps (Apple Marketplace : 95 HTN; 242BP)

Majority appear to have not been developed using theory based, patient/provider centered, data driven, iterative approach

Healthcare providers seek validated effective programs following SOC guidelines (FDA approval, Happtique –clearing house)

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http://sctr.musc.edu843-792-8300

Purpose Incorporate theory driven, patient & provider

centered, iterative model for devpt of mHealth self management programs

MRC’s Update on Guidance for Devpt of Complex Interventions

Utilize it in 2 proof of concept RCTs

http://sctr.musc.edu843-792-8300

Iterative Design Model

Problem Selecting

Observing

Refra

min

g an

d Ac

com

mod

ating

Solution Finding

Converging

Experimenting

Diverging

Lit Review; theory selection

Interview focus group. (Barriers, poss approaches)

Surveys(n=99; 80)

SMASH devpt

Feasibility trialPOC trial

Efficacy/effectiveness trial

Personalized Feedback Development

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Participants Uncontrolled Hypertensives 6 Hispanics (low SES, rural, farmers)

• Prescribed 1-2 meds but not taking any 6 Kidney transplant patients (3 AAs, 2 Ws, 1 H)

• 3 mths post transplant• 8-10 meds(bid; tid)• 1 month adherence <.85

http://sctr.musc.edu843-792-8300

Methods Clinic Evaluations :

• Resting BP: Pre-intervention 1,2, & 3 mths • 24 hr BP: Pre-intervention & 3 mths

2 Arm RCT: SMASH vs SOC:• Maya MedMinder• Bluetoothed Fora D15b BP/glucometer

and A&D UA-767 PBT BP monitor• Android phone-data transmission, immed. feedback & personalized messages

SMASH (BP/Glucose) Control ProgramBased upon Self Determination Theory & Patient Centered Iterative Stage Devpt.

Share data with EMR. Automated summary reports and alerts to clinician.

Automated Personalized Messages

SMASH Workflow Model

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Results Hispanic POC 100% recruitment & retention rates Med adherence of .96 over 3 mths

Resting SBP across 3-months by Intervention Group

SBPpre SBP3mo DBPpre DBP3mo60

70

80

90

100

110

120

130

140

150151.28

122.74

98.13

78.22

140.19 139.56

79.683.4

24-Hr. ABP

SMASH SOC

SB

P|D

BP

(mm

Hg

)

24 Hour SBP and DBP at Pre-Intervention and Trial Completion by Intervention Group

SMASH -meds changed twice vs none in SOC

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Results cont. Kidney Transplant Patients POC 100% recruitment & retention rates 6/8 < 85% adherence during 1 mth screening SMASH-meds changed twice vs none in SOC

Medication Adherence Rates* Group Screening 1 mth 2 mth

SMASH 69.8 93.4 96.2 SOC 54.5 42.7 57.5

*Russell et al (2010) algorithm (eg, bid: .5 within 90min; .25 within 3hrs )

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Results cont.

Pre 1 2 3 4 5 6130

140

150

160

148.67

139.67

133.67

140.50

150.50 150.00

SMASH SOC

Months Intervention

SB

P (

mm

Hg

)

Clinical Hypertension

Kidney Transplant Patients Resting SBP Changes

http://sctr.musc.edu843-792-8300

Discussion SMASH had high patient & provider acceptability Significant & sustained med adherence achieved Sustained BP control achieved (resting BP <140/90;

24 hr BP < 135/80 mmHg), not typically achieved in previous trials

Indications that SDT constructs achieved (self efficacy & intrinsic motivation) based upon 3 mth follow up

Theory guided, iterative patient –provider centered model adaptable to other mHealth patient self management paradigms

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http://sctr.musc.edu843-792-8300

Thank you

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