Mobile Health Technology: Catalyst for
Healthcare Transformation
Essential Hypertension as an Example
Subtitle
Frank
Treiber, PhD
Presenters
South Carolina Smart
State Endowed Research Chair
Director of Technology Applications Center for Healthful Lifestyles(TACHL)
Date
Professor of Nursing & Psychiatry
Presented to : Verizon Foundation Conference , 4/2/2012.
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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 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.
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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
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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
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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.
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mHealth Technology
MedMinder
MedMinder Processing Center
Medication Reminder Device
Microsoft
HealthVault
Alert Indicators
Flashing Light
Chime
Cell phone call
AND BP
Monitor
Adherence
Coach
Android
Phone
Healthcare
Provider
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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
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Ambulatory SBP Changes at 3 months
0.00
Change in SBP (mmHg)
-1.25
-5.00
-10.00
SMASH
-13.58
-15.00
-20.00
-18.85
-20.53
-25.00
WAKE
SLEEP
SOC
Resting SBPs at Clinic
160
154.17
Systolic BP (mmHg)
150
140
-14.83
SMASH
130
-25.33
-26.67
120
0
1
2
Month
3
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: 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)
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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
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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
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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)
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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
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843-792-8300