Patient Centered Health Technology Medication Adherence Program for African American Hypertensives



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 59
Updated:3/16/2019
Start Date:April 28, 2017
End Date:June 30, 2021
Contact:Frank A Treiber, PhD
Email:treiberf@musc.edu
Phone:843-792-8852

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This will be a two--arm Randomized controlled trial (RCT) design that will assess efficacy of
the Smartphone Medication Adherence Stops Hypertension (SMASH) mobile health ( mHealth)
program compared to an enhanced standard care (SC) program. Participants will be
African-American (AA) hypertension patients with no other known chronic diseases.

Participants found to have uncontrolled hypertension (HTN) and medication non-adherence via
electronic device monitoring will be randomized to SMASH or enhanced Standard Care (SC). The
SMASH group will receive reminders in the form of auditory and visual reminders from a pill
monitoring device when their medication dose is due, they will monitor their blood pressure
at home and will receive tailored motivational text messages based upon levels of adherence .
Enhanced SC group will use the pill monitoring device without reminder functions enabled and
will receive text messages on topics of healthy lifestyles not related to medication
adherence and hypertension.

The active intervention will continue for 6 months and follow-up will continue for 1 year.

192 AAs (21-59 yrs ) with uncontrolled HTN (no other comorbidities) and Medication
Non-Adherence (MNA) will be recruited according to the inclusion and exclusion criteria found
elsewhere. In the first phase of screening,resting BP protocols will be performed to
determine hypertension is uncontrolled. Only subjects with verified uncontrolled HTN will
proceed to the second screening phase .This is a 4 week medication monitoring phase using an
electronic medication device with reminder alerts deactivated.Medication non-adherence (MNA)
will be determined through medication possession ratio and by the timestamped intake
adherence to their predesignated intake schedule across the 4 week period. MA score <0.85
over the 4-week screening and whose subsequent resting BP evaluations reconfirm uncontrolled
HTN will be eligible for enrollment into the RCT.

SMASH subjects will have their pill monitor reminder functions activated, start receiving
personalized motivational text messages and provided and instructed on use of a validated
Bluetooth--enabled BP monitor used at home during the intervention period.

Enhanced SC subjects will continue to use the pill device with reminder functions disabled
for another 6 months. In order to control for attention exposure SC subjects will be sent
text messages on topics related to healthy lifestyle behaviors (diet, physical activity,no
smoke exposure) but not related to Medication Adherence (MA) or HTN.

All subjects will complete 5 study visits where BP,medication possession ratios, and surveys
will be completed. 24-hour Ambulatory Blood Pressure (ABP) monitoring will be performed every
6-months (4 times) during the study.

Inclusion Criteria:

1. African American or Black, 21--59 years old

2. Prescribed medication(s) only for HTN

3. Medication possession ratio (MPR) <.85 for last 3 months

4. uncontrolled HTN (SBP ≥130 mmHg) based upon last clinic visit within previous 12
months, initial clinic screening & subsequent baseline recruitment evaluation
following one month med intake screening with score of <.85

5. 24--hour SBP ≥ 130 mmHg on clinic screening and subsequent recruitment evaluation

6. Ability to speak, hear and understand English

7. Able to take their own BP and self--administer medications

8. Owns smart phone with data plan

9. Primary care provider's assent that patient is able to participate

Exclusion Criteria:

1. No other known chronic disease (e.g., chronic kidney disease (GFR<50 mL/1.7 m2/min;;
diabetes (type one or two) renal dialysis cancer diagnosis or treatment in past 2
years prior cv event such as heart attack, congestive heart failure, arterial stent,
coronary artery bypass graft psychiatric illness

2. Beck Depression Inventory score >13

3. Ongoing substance abuse (e.g., >21 drinks/week)

4. Planned pregnancy

5. Vulnerable populations such as pregnant or nursing women, prisoners, and
institutionalized individuals.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-8852
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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