Supporting Tailored Adaptive Change and Reinforcement for Medication Adherence Program: Randomized Trial of a Novel Approach to Improve Adherence in Older Hypertensive Women and Men
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Tulane University
- Enrollment
- 402
- Locations
- 5
- Primary Endpoint
- Difference in proportion with PDC >=0.8 at 12 months
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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)
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
Outcomes
Primary Outcomes
Difference in proportion with PDC >=0.8 at 12 months
Time Frame: 12 months
Proportion of days covered (PDC) calculated from pharmacy refill data
Secondary Outcomes
- Difference in proportion with controlled BP at 12 months(12 months)
- Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months(12 months)
- Difference in mean change in SBP, baseline to 12 months(Baseline to 12 months)
- Difference in mean change in PDC, baseline to 12 months(Baseline to 12 months)
- Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months(Baseline to 12 months)
- Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months(Baseline to 12 months)
- Difference in mean change in DBP, baseline to 12 months(Baseline to 12 months)
- Difference in mean change in health-related quality of life scores, baseline to 12 months(Baseline to 12 months)