Medication Adherence Program (MAP)

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

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.

The Data Manager will calculate the primary outcome measure from pharmacy refill data prior to merging with any data file indicating group assignment. BP measurements will be collected by research clinic staff, who will be blinded to 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.

Interactive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior

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))

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))

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

Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol

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))

Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 6 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))

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))

Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 6 months

Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications

Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol

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))

Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 24 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))

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))

Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 24 months

Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications

Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol

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))

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