Medication Adherence Program
- Conditions
- HypertensionMedication AdherenceBehavior and Behavior Mechanisms
- Interventions
- Behavioral: STAR-MAP health coachingBehavioral: Medication reminder tools
- Registration Number
- NCT05183763
- Lead Sponsor
- Tulane University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 402
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STAR-MAP STAR-MAP health coaching Interactive health coaching sessions and medication reminder tools STAR-MAP Medication reminder tools Interactive health coaching sessions and medication reminder tools Medication App and Reminder System Medication Adherence Program (MARS-MAP) Medication reminder tools Medication reminder tools only
- Primary Outcome Measures
Name Time Method Difference in proportion with PDC >=0.8 at 12 months 12 months Proportion of days covered (PDC) calculated from pharmacy refill data
- Secondary Outcome Measures
Name Time Method Difference in proportion with controlled BP at 12 months 12 months Controlled blood pressure (BP) defined as systolic BP \<130 mm Hg and diastolic BP \<80 mm Hg; BP measured using standardized protocol
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months 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))
Difference in mean change in SBP, baseline to 12 months Baseline to 12 months Systolic blood pressure (SBP) measured using standardized protocol
Difference in mean change in PDC, baseline to 12 months Baseline to 12 months Proportion of days covered (PDC) calculated from pharmacy refill data
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months 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))
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months Baseline to 12 months Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications
Difference in mean change in DBP, baseline to 12 months Baseline to 12 months Diastolic blood pressure (DBP) measured using standardized protocol
Difference in mean change in health-related quality of life scores, baseline to 12 months 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))
Trial Locations
- Locations (5)
Tulane Doctors Dermatology & Multispecialty Clinic
🇺🇸Covington, Louisiana, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Tulane Doctors Heart & Vascular and Primary Care Clinic
🇺🇸Metairie, Louisiana, United States
LSU Health Sciences Shreveport Clinical Trials Office
🇺🇸Shreveport, Louisiana, United States
Tulane University Clinical and Translational Unit
🇺🇸New Orleans, Louisiana, United States