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Medication Adherence Program
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.
Conditions:
🦠 Hypertension 🦠 Medication Adherence 🦠 Behavior and Behavior Mechanisms
🗓️ Study Start (Actual) 7 March 2022
🗓️ Primary Completion (Estimated) 30 April 2026
✅ Study Completion (Estimated) 30 April 2027
👥 Enrollment (Estimated) 402
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baton Rouge, Louisiana, United States
📍 Covington, Louisiana, United States
📍 Metairie, Louisiana, United States
📍 New Orleans, Louisiana, United States
📍 Shreveport, Louisiana, United States

📋 Eligibility Criteria

Description

    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: 50 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 December 2021
  • First Submitted that Met QC Criteria 17 December 2021
  • First Posted 11 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 April 2024
  • Last Update Posted 12 April 2024
  • Last Verified April 2024
I'm interested ...!!