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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
402
Interactive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior
Medication-taking reminder app and pillbox
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
RECRUITINGTulane Doctors Dermatology & Multispecialty Clinic
Covington, Louisiana, United States
RECRUITINGTulane Doctors Heart & Vascular and Primary Care Clinic
Metairie, Louisiana, United States
RECRUITINGTulane University Clinical and Translational Unit
New Orleans, Louisiana, United States
RECRUITINGLSU Health Sciences Shreveport Clinical Trials Office
Shreveport, Louisiana, United States
RECRUITINGDifference in proportion with PDC >=0.8 at 12 months
Proportion of days covered (PDC) calculated from pharmacy refill data
Time frame: 12 months
Difference in mean change in PDC, baseline to 12 months
Proportion of days covered (PDC) calculated from pharmacy refill data
Time frame: 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))
Time frame: 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))
Time frame: 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
Time frame: 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
Time frame: 12 months
Difference in mean change in SBP, baseline to 12 months
Systolic blood pressure (SBP) measured using standardized protocol
Time frame: Baseline to 12 months
Difference in mean change in DBP, baseline to 12 months
Diastolic blood pressure (DBP) measured using standardized protocol
Time frame: 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))
Time frame: Baseline to 12 months
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