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http://sctr.musc.edu 843-792-8300 Mobile Health Technology: Catalyst for Healthcare Transformation Essential Hypertension as an Example Subtitle Presenters Date Frank Treiber, PhD South Carolina Smart State Endowed Research Chair Director of Technology Applications Center for Healthful Lifestyles(TACHL) Professor of Nursing & Psychiatry Presented to : Verizon Foundation Conference , 4/2/2012.

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

Mobile Health Technology: Catalyst for Healthcare Transformation

Essential Hypertension as an Example

SubtitlePresenters

Date

Frank Treiber, PhDSouth Carolina Smart State Endowed Research Chair

Director of Technology Applications Center for Healthful Lifestyles(TACHL)

Professor of Nursing & Psychiatry Presented to : Verizon Foundation Conference , 4/2/2012.

,

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

Rationale for three interrelated community based projects

• Essential hypertension (EH) impacts 33% of US adults• EH is a significant risk factor for CVD, heart attack, stroke,

renal failure • Antihypertensive meds. control EH and decrease CVD events• Medication nonadherence is leading contributor to

uncontrolled EH• Among EH patients, nonadherence highest among Hispanics

and African Americans in underserved areas• Practical, sustainable adherence and BP management

programs needed

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Rationale contd.

• Reviews of clinical trials indicate the following improve medication adherence and BP control: Self monitoring of BP Medication reminder tactics Pharmacist /nurse educational & motivational programs Effects usually deteriorate following cessation of

program Comprehensive, acceptable and sustainable patient

centered program has not been developed

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Proof of Concept Study Design and Methods

Subjects: 3 adult prehypertensives (SBP > 120 mmHg)

Procedures:Received Tension Tamer, asked to practice 10 minute sessions 2x a day for 3-months

Measures collected at preintervention 1, 2, and 3 months:

-Resting Hemodynamics and 24-Hour Ambulatory BP-Overnight Urine Sample-Awakening response saliva sampling

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Tension Tamer Heart Rate Acquisition

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Tension Tamer Results

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Proof of Concept ResultsReductions in Salivary Alpha-Amylase awaking curve (Marker of SNS activity) from pre to post 3 month intervention.

Dose-Response Reductions in 24 hour Ambulatory Blood Pressure. Reductions corresponded with Tension Tamer Adherence rates.

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Proposed Feasibility Study Design and Methods

Subjects: 60 stage 2 preEH adults (SBP 130-139 mmHg)

Procedures:Random assignment to Tension Tamer or standard of care 6 months

Measures collected at preintervention 1, 3, 6, and 12 months:

-Resting Hemodynamics and 24-Hour Ambulatory BP-Overnight Urine Sample-Repeated saliva sampling

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Rationale contd.

• mHealth technology enables opportunity to integrate these tactics and help: Patients establish self management skills Patients avoid frequent office visits/check ups, etc. Providers deliver care in more timely manner Facilitate communication between providers &

patients Establish and sustain BP control

Preparatory Findings

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• Key Informant Interviews FQHC patients (21 minorities, mean age: 34.5 yrs.) 29% had uncontrolled EH None had taken meds. in 1 yr. (reasons: poor

planning; forgetfulness) 95% owned cell phones (20% had smart phones) All highly receptive to using mHealth technology for

med. adherence, BP monitoring, linkage to doctor & fewer trips to clinic

Preparatory Findings Contd.

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• Mini Proof of Concept Study Purpose: Determine acceptability of the mobile

tech. system to patients and providers 4 uncontrolled EH FQHC patients (2 Standard of

Care [SOC] , 2 SMASH) for 3 months.

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mHealth Technology

Alert IndicatorsFlashing LightChimeCell phone call

MedMinder Processing Center

Microsoft HealthVault

Adherence Coach

AND BP Monitor

MedMinderMedication Reminder Device

Android Phone

Healthcare Provider

Preparatory Findings Contd.

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• SMASH Results: High levels of patient & provider acceptability; 95-100% med. & BP adherence rates; High desire to continue SMASH; Large, sustained BP reductions; EH became controlled

WAKE SLEEP-25.00

-20.00

-15.00

-10.00

-5.00

0.00

-18.85

-20.53

-1.25

-13.58

Ambulatory SBP Changes at 3 months

SMASHSOC

Chan

ge in

SBP

(mm

Hg)

0 1 2 3120

130

140

150

160

Resting SBPs at Clinic

SMASH

Month

Syst

olic

BP

(mm

Hg)

154.17

-26.67

-14.83

-25.33

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SMASH Time Table

• Months 1-3: Focus Groups & Key Informant Interviews: Refine SMASH (e.g., motivational /reinforcement messages, educational messages /video clips; feedback reports)

• Months 4-6: Complete software programming based upon above findings

• Months 7-12: 3 month SMASH vs. SOC pilot clinical trial (16 EHs from 2 FQHCs)

• Months 13-15: Statistical analyses, follow-up focus groups for SMASH refinement

• Months 16-24: 6 month feasibility clinical trial (48 EHs from 6 FQHCs)

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Months 7-12: SMASHPilot Trial: Design & Methods

• Subjects: 16 uncontrolled EH, AAs and Hispanics • Procedures:

Random assignment by FQHC to MedMinder/BP system vs. SOC for 3 months

Smart phones used for signal transfer and patient –provider linkage

Provider summary reports bi-monthly; immediate alerts when beyond thresholds

Measurements at pre-treatment, 1, 2 and 3 months (resting hemodynamics, 24hr Ambulatory BP)

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

Months 16-24: SMASHFeasibility Trial: Design & Methods

• Subjects: 48 uncontrolled EH, AAs and Hispanics • Procedures:

6 FQHCs (8 uncontrolled EHs per clinic) Random assignment by FQHC to SMASH vs. SOC for

6 months Measurements at pre-treatment, 3 and 6 months

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Rationale• ESRD afflicts more than 500,000 people in the USA• HTN and DM are the #1 and #2 causes of ESRD • Kidney transplantation is the treatment of choice for

ESRD• Kidneys are an incredibly scarce resource which

mandates that their use be optimized• Despite significant advances, average graft survival is

suboptimal at approximately 9 years• Graft survival is worse among African-Americans and

those of lower socioeconomic status

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Rationale• Medication nonadherence is key contributor to

premature graft loss• Approximately 35% of renal transplant patients are

nonadherent and issues often develop within weeks of transplantation

• Medication nonadherence contributes to graft loss by allowing for immune mediated rejection and the deleterious effects of poorly controlled HTN and DM

• Mobile health technology has the potential to improve medication adherence, blood pressure and blood sugar control, and graft survival

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Aim• Utilize wireless technology to identify nonadherent

patients early after transplant and to interact with them in real time to improve adherent behaviors as a means to improve:• Medication adherence• Control of HTN• Control of DM• Graft survival

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Study Design and Methods• Type: Randomized control trial• Subjects: 20 nonadherent kidney transplant patients• Methods: randomly assigned to:• Group A: standard post operative care• Group B: “bundled” wireless real time

medication reminder system, blood pressure/blood glucose monitoring, cognitive behavior adherence skills enhancement program

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

Study Design and Methods• Technology• Maya MedMinder to monitor and aid in

medication adherence• Bluetooth enabled Fora D15b to measure and

record BP and blood glucose• “Smart” phones for signal transmission• “Smart” phones for patient interaction• Cognitive behavioral enhancement techniques

via video conferencing with adherence coach

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Study Design and Methods• Outcomes (measured pre-, 1, 2, and 3 months):

• Medication adherence (Maya MedMinder)

• Blood pressure control (Fora D15b, 24h ambulatory BP)

• Blood glucose control (Fora D15b, HgbA1c)

• Immunosuppression (FK506 variability)

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

Rationale• Essential hypertension (EH) impacts 33% of US adults,

higher prevalence among African Americans (AAs).• EH is a significant risk factor for CVD, heart attack, stroke,

renal failure.• Leading predictor of EH is preEH (SBP/DBP 121-139/81-89

mmHg)• Sustainable/easily disseminated prevention programs

needed• Breathing meditation shown to reduce BP among EH and

preEH AA patients • Smartphones enable large-scale/easy dissemination