Medication Adherence Program

Last updated: March 17, 2025
Sponsor: Tulane University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Circulation Disorders

Vascular Diseases

Treatment

STAR-MAP health coaching

Medication reminder tools

Clinical Study ID

NCT05183763
2020-2221
R01HL153750
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ≥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

Exclusion

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

Study Design

Total Participants: 402
Treatment Group(s): 2
Primary Treatment: STAR-MAP health coaching
Phase:
Study Start date:
March 07, 2022
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • Tulane Doctors Dermatology & Multispecialty Clinic

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Tulane Doctors Heart & Vascular and Primary Care Clinic

    Metairie, Louisiana 70002
    United States

    Active - Recruiting

  • Tulane University Clinical and Translational Unit

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • LSU Health Sciences Shreveport Clinical Trials Office

    Shreveport, Louisiana 71101
    United States

    Active - Recruiting

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