Medication Adherence Program
Part of paid clinical trials in Baton Rouge, Louisiana.
- Sponsor
- Tulane University
- Study ID
- NCT05183763
- Status
- Recruiting
Conditions
- Behavior and Behavior Mechanisms
- Hypertension
- Medication Adherence
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- STAR-MAP health coaching — BEHAVIORALInteractive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior
- Medication reminder tools — BEHAVIORALMedication-taking reminder app and pillbox
Study Details
Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. Participants (n=402) \>=40 years old with a diagnosis of hypertension, uncontrolled blood pressure, and low antihypertensive medication adherence will be recruited through a statewide health insurer, Blue Cross Blue Shield of Louisiana, and randomized to receive either interactive health coaching sessions with medication reminder tools (intervention) or medication reminder tools only (control) over one year. Data will be collected from participants at baseline, 6 months, 12 months, and 24 months using questionnaires, physical measurement (height, weight, blood pressure), a computer-based single-category implicit association test, and laboratory analysis of antihypertensive medication urinary metabolites.
Key Dates
- Start date
- Mar 7, 2022
- Status verified
- May 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 402 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: STAR-MAPInteractive health coaching sessions and medication reminder tools
- Active Comparator: Medication App and Reminder System Medication Adherence Program (MARS-MAP)Medication reminder tools only
Primary Outcome Measure
Difference in proportion with PDC >=0.8 at 12 months [ Time Frame: 12 months ]
Central Contacts
- Erin M Peacock, PhD, MPH504-988-1075
- Marie A Krousel-Wood, MD, MSPH504-988-7056
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | |
| Tulane Doctors Dermatology & Multispecialty Clinic | Covington | Louisiana | 70433 | |
| Tulane Doctors Heart & Vascular and Primary Care Clinic | Metairie | Louisiana | 70002 | |
| Tulane University Clinical and Translational Unit | New Orleans | Louisiana | 70112 | |
| LSU Health Sciences Shreveport Clinical Trials Office | Shreveport | Louisiana | 71101 |
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