NCT03454308

Patient Centered Health Technology Medication Adherence Program for African American Hypertensives

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 21 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypertension
• Medication Non-Adherence

Interventions

Type	Name	Description
BEHAVIORAL	SMASH	Auditory and visual reminders are active on Pill device will alert subject each time their medication dose is due. Pill device will transmit dose taken time stamps to researchers. Text message the following morning with tailored motivational messages that reflect the medication dose adherence from the preceding day. Subjects will monitor their BP at home at least every third day using Bluetooth monitor linked to smartphone to transmit encrypted readings to researchers.
BEHAVIORAL	Enhanced SC	Auditory and visual reminders are inactive on Pill device. Pill device will transmit dose taken times to researchers. Healthy lifestyle test messages as attention control.

Timeline

• Start date: 2017-04-28
• Primary completion: 2021-08-17
• Completion: 2021-08-17
• First posted: 2018-03-05
• Last updated: 2025-06-13
• Results posted: 2025-06-13

Locations

1 site across 1 country: United States