Medication Adherence Program
Purpose
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.
Conditions
- Hypertension
- Medication Adherence
- Behavior and Behavior Mechanisms
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- fully insured by Blue Cross Blue Shield of Louisiana (BCBSLA) - continuously enrolled in BCBSLA for one year - planning to remain a member of BCBSLA for next year - English-speaking - telephone access - aged ≥40 years - diagnosis of essential hypertension (ICD-10-CM code I10) - currently filling antihypertensive medication - low antihypertensive medication refill (proportion of days covered (PDC) <0.8) - low self-report adherence (4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4) score ≥1) - uncontrolled blood pressure (BP) (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg) - desire to improve BP
Exclusion Criteria
- living in a household with someone already enrolled in the study - enrollment in another clinical trial for drug adherence or BP control - moderate to severe cognitive impairment
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Double (Care Provider, Outcomes Assessor)
- Masking Description
- The Data Manager will calculate the primary outcome measure from pharmacy refill data prior to merging with any data file indicating group assignment. Laboratory technicians who perform the liquid chromatography tandem mass spectrometry analysis of urine metabolites of antihypertensive medications will also be blinded to group assignment. Finally, participants' primary care providers will be notified of their patients' enrollment into the study but will not be given information about group assignment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental STAR-MAP |
Interactive health coaching sessions and medication reminder tools |
|
|
Active Comparator Medication App and Reminder System Medication Adherence Program (MARS-MAP) |
Medication reminder tools only |
|
Recruiting Locations
New Orleans, Louisiana 70112
Metairie, Louisiana 70002
Covington, Louisiana 70433
More Details
- Status
- Recruiting
- Sponsor
- Tulane University