Medication Adherence Program
Recruiting · NCT05183763 · Interventional (participants receive a specific treatment) · Lead sponsor: Tulane University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
5 locations listed across 1 US state.
- Pennington Biomedical Research Center - Baton Rouge, Louisiana, United States
- Tulane Doctors Dermatology & Multispecialty Clinic - Covington, Louisiana, United States
- Tulane Doctors Heart & Vascular and Primary Care Clinic - Metairie, Louisiana, United States
- Tulane University Clinical and Translational Unit - New Orleans, Louisiana, United States
- LSU Health Sciences Shreveport Clinical Trials Office - Shreveport, Louisiana, United States