mHealth Enabled Patient & Provider Centered Medical

Regimen Adherence Solutions for Uncontrolled Hypertension

Frank Treiber, PhD.

Professor of Nursing & Psychiatry

Director, Technology Applications Center

for Healthful Lifestyles (TACHL)

Medical University of South Carolina

Presented at: Society of Behavioral Medicine Conference

Washington, D.C. 3/31/16

HL118447 UL1 RR029882 KL2 &

DK103839

SC Telemedicine Initiative & UL1

RR029882

Objectives

1. Brief overview of medication nonadherence

2. Rationale for using mHealth

3. Rationale for user patient centered, theory

guided , iterative design process

4. Provide example of this process with 4 patient

populations with uncontrolled EH:

Kidney transplant patients

FQHC Hispanic migrant farmers

FQHC African Americans

Post stroke patients

Obj.#1: Patient Nonadherence to Medication Regimens

Leading obstacle in chronic disease management 25% of initial scripts never filled ~ 50% of patients with chronic disease(s) adhere to med regimens

Med nonadherence responsible for : 10% of hospitalizations reduced work force productivity suboptimal clinical outcomes (~125,000 deaths/yr ) increased healthcare costs $100- 300 B/yr

Obj.#2: Why use mHealth in Tackling Patient Nonadherence to Med Regimens ?

Ubiquity of Mobile Phones: ~93% of Americans have cell phones ~63% own Smart Phones ~64% use phone to access health info

mHealth solutions: increase quality, reach & personalization of care available 24/7; provide timely access to therapeutic support “snap shot clinic visit” issue addressed –HCPs know how

patient is functioning & can address needs quicker

Obj.#3: Why Use Theory Guided, User Centered, Iterative Design Process?

Insurers, Hospital & health plan execs & HCPs need:

Evidence based, empirically validated, sustainable & cost effective solutions;

ACCOMPLISHED using: iterative design process guided by patient & provider input

behavioral & tech. application theories ( foster self efficacy & intrinsic motivation to sustain adherence to medical regimen )

Empirical evaluations & repeated refinements establishing usability, efficacy, effectiveness & sustainability

Development of personalized, sustainable, effective solutions

4. Usability Testing

5. Further Development

6. User Surveys

7. Refine prototype

1. User Needs Content/Function

• Focus groups

• Interviews

2. Qualitative Analysis

3. Prototype Development

Users

ResearchersDesign Team

Clinical Trials

Proof of Concept

Efficacy/ Effectiveness

Dissemination

Post Trial Focus

Groups

Iterative Design ProcessEngages all stakeholders from

generation of clinical need

through all iterative

design phases

Obj.#4a: Development of mHealth Medication Adherence & BP Control Program Among Kidney Transplant

Recipients (KTRs)

UL 1 RR029882KL2 10/11-9/14

RO1 DK103839

10/15-9/19

Rationale

ESRD afflicts >500,000/yr in USA EH is the #1 cause of ESRD

Transplantation is treatment of choice Despite advances, graft survival stagnant: M=9 yrs (S.C. 4.5 yrs)

Medication nonadherence: Key cause of premature graft loss (35-45%) Fosters immune mediated rejection &

deleterious effects of uncontrolled EH & DM

Iterative Design Process of Prototype System

Individual interviews conducted to determine: healthcare providers’ needs for following KDIGO & MUSC

stepped care guidelines & perspectives on premature graft loss

patients’ functional health literacy, attitudes toward, willingness and ability to use mHealth

Iterative Development of mHealth Prototype System cond.

Prototype mHealth system developed (SMASH)& usability tested

99 KTRs surveyed after demo of SMASH mHealth system

Further SMASH Refinement Feasibility trial conducted Post trial interviews & further refinement Efficacy RCT underway

Survey Results of mHealth prototype: SMASH

90% cell phones; 52 % had smart phone access

61% texted; 34% downloaded apps

7% had heard of mHealth/Telehealth

79% very willing to use mHealth

87% very confident mHealth would increase communication with physician

84% felt doctor would make quicker med changes

McGillicuddy et al. (2014) Journal Medical Internet Research

TACHL Prototype

SMASH SystemMedication Reminder

Devices

AND Monitor

Time Stamped Events

Identification of Tailored Motivational Message Content

Yes

Yes

Yes

Tailored Motivational MessageExample

Background: 55 yr.-old single with EH & T2D. Family history: parents with EH,

T2D & ESRD.

Life goals & personal values: religious, desires to spend more time with

family, worries about dying young from kidney disease or a stroke like his parents

Medication dose(s) taken correctly:Great, Frank! You’re taking your meds on time! Your family history does not have to be your future!

Missed medication dose(s):Frank, try and remember to take your meds on time every day! God has blessed you, take care of His gift of life!

Medication Adherence in KTRs

60

89

92 95

50

53

59

56

40

50

60

70

80

90

100

Baseline Month 1 Month 2 Month 3

Pe

rce

nt

Ad

he

ren

ce

mHealth

SOC

McGillicuddy et al.(2013a,b) Journal of Assn. Computing Machinery & Journal of Medical Internet Research

Average of 13.5 different meds/bid-qid

McGillicuddy et al (2013) Journal of Medical Internet Research

BP Changes Among KTRs

138.4

129.3

129.6

121.8

135.1

147.2

138.2

138.8

120

125

130

135

140

145

150

0 1 2 3

Smash

SC

Month

Ave

rage

SBP

Month

Ave

rage

SBP

SC

Month

Ave

rage

SBP

Month

Ave

rage

SBP

SC

Month

Ave

rage

SBP

Month

Ave

rage

SBP

SC

Month

Ave

rage

SBP

Month

Ave

rage

SBP

(m

mH

g)

SC

SMASH

McGillicuddy et al. (2015) Progress in Transplantation

One Year Follow-up Clinic BP Among KTRs

145.38143.88

154.50

135.63

132.25131.13

125

130

135

140

145

150

155

160

End of Trial 6 Month 12 Month

Clin

ic S

BP

(m

mH

g)

Follow Up

SC

SMASK

Obj.#4b: Development of mHealth Medication Adherence & BP Control Program Among

Hispanic Hypertensives

Highest rate of uncontrolled EH in USA

Fastest growing ethnic group

>50% Nonadherent to medication regimen

Obj.#4b: mHealth (SMASH) & Hispanic Uncontrolled Hypertensives

Focus groups & surveys led to SMASH prototype refinement 81% cell phone; 39% smart phone

78% texted; 48% downloaded apps

19% had heard of mHealth

94% very willing to use mHealth

76% had complete trust in privacy of data

85% very confident mHealth would increase communication with physician

Price et al. (2013) Journal Medical Internet Research

HL 118447 4/14-3/17

• SMASH med adherence 96% across 3 mths

SMASH Wake SMASH Sleep SOC Wake SOC Sleep

100

110

120

130

140

150

160

Pre

3mo

156.43

126.61

146.36

117.72

142.72

144.66

132.79

132.42

Ave

rage

SB

P (

mm

Hg)

Ambulatory SBP

Sieverdes et al. (2013) Mobile Health Telecare

BP Changes & Med Adherence Among Hispanic FQHC Uncontrolled Hypertensives

160

123.5120.9

112.8

147.8

138.5 136.5 136.7

100

110

120

130

140

150

160

170

Pre 1 2 3

SBP

(m

mH

g)

Months

Resting SBP

SMASH

SC

Baseline

Obj.#4c: SMASH with African American FQHC Patients & Post Stroke patients Uncontrolled

Hypertensives

163.68163.36

153.00152.77163.25

132.63129.00

125.06

120

130

140

150

160

170

Baseline 1 3

Ave

rage

SB

P (

mm

Hg)

Months

Clinic SBP: AA FQHC patients

SOC

SMASH

Davidson et al. (2015) Journal of Personalized Medicine Ovbiagele et al. (2015) J. of the Neurological Sciences

- 7.7% ED use

- 57% ED use

156.7

151 151.3153.8

136

138.8

130

135

140

145

150

155

160

6 Month Prior 3 Month Program 3 Month Post-Program

Clin

ic S

BP

Interval

MUSC Stroke Quality Improvement Program

SC

mHealth

-20% ED use

-85% ED use

Baseline

Discussion

SMASH has high patient & provider acceptability

Significant & sustained med adherence achieved

Sustained BP control achieved (resting BP <140/90; 24 hrBP < 135/80 mmHg), not typically achieved in previous trials

Indications that SDT constructs enhanced (self-efficacy & intrinsic motivation) based upon 3 & 12 mth follow-ups

Theory guided, iterative patient–provider centered designs useful in mHealth enabled medical regimen self-management programs