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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)
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Mobile Health Technology: Catalyst for Healthcare TransformationEssential 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. , http://sctr.musc.edu 843-792-8300
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 http://sctr.musc.edu 843-792-8300
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 http://sctr.musc.edu 843-792-8300
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 http://sctr.musc.edu 843-792-8300
Tension Tamer Heart Rate Acquisition http://sctr.musc.edu 843-792-8300
Tension Tamer Results http://sctr.musc.edu 843-792-8300
Proof of Concept Results • Reductions 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. http://sctr.musc.edu 843-792-8300
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 http://sctr.musc.edu 843-792-8300
Rationale contd. • mHealthtechnology 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 http://sctr.musc.edu 843-792-8300
Preparatory Findings • 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 http://sctr.musc.edu 843-792-8300
Preparatory Findings Contd. • 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. http://sctr.musc.edu 843-792-8300
mHealth Technology http://sctr.musc.edu 843-792-8300
Preparatory Findings Contd. • 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 http://sctr.musc.edu 843-792-8300
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) http://sctr.musc.edu 843-792-8300
Months 7-12: SMASH • Pilot 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.edu 843-792-8300
Months 16-24: SMASH • Feasibility 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 http://sctr.musc.edu 843-792-8300
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 http://sctr.musc.edu 843-792-8300
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 http://sctr.musc.edu 843-792-8300
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 http://sctr.musc.edu 843-792-8300
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.edu 843-792-8300
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 http://sctr.musc.edu 843-792-8300
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.edu 843-792-8300
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 http://sctr.musc.edu 843-792-8300