Medication Adherence Program

Study Overview
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Brief Summary
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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) >=50 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.

Official Title
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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

Conditions
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Hypertension, Medication Adherence, Behavior and Behavior Mechanisms

Intervention / Treatment
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* Behavioral: STAR-MAP health coaching
* Behavioral: Medication reminder tools


Participation Criteria
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Eligibility Criteria
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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 ≥50 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STAR-MAP<br>Interactive health coaching sessions and medication reminder tools | Behavioral: STAR-MAP health coaching<br>* Interactive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior<br>Behavioral: Medication reminder tools<br>* Medication-taking reminder app and pillbox<br>|
| Active Comparator: Medication App and Reminder System Medication Adherence Program (MARS-MAP)<br>Medication reminder tools only | Behavioral: Medication reminder tools<br>* Medication-taking reminder app and pillbox<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in proportion with PDC >=0.8 at 12 months | Proportion of days covered (PDC) calculated from pharmacy refill data | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean change in PDC, baseline to 12 months | Proportion of days covered (PDC) calculated from pharmacy refill data | Baseline to 12 months | 
| Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months | Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence)) | Baseline to 12 months | 
| Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months | Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence)) | 12 months | 
| Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months | Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications | Baseline to 12 months | 
| Difference in proportion with controlled BP at 12 months | Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol | 12 months | 
| Difference in mean change in SBP, baseline to 12 months | Systolic blood pressure (SBP) measured using standardized protocol | Baseline to 12 months | 
| Difference in mean change in DBP, baseline to 12 months | Diastolic blood pressure (DBP) measured using standardized protocol | Baseline to 12 months | 
| Difference in mean change in health-related quality of life scores, baseline to 12 months | Quality of life measured using 12-item Short Form Survey (SF-12); scores for eight subscales, Mental Component Summary, and Physical Component Summary calculated and compared (minimum: 0 (worse quality of life); maximum: 100 (better quality of life)) | Baseline to 12 months |