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NCT05183763NARecruiting

Medication Adherence Program

Tulane University

Start Date

3/7/2022

Completion Date

4/30/2027

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

Age Range: 40 years to No maximum

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 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

Interventions

BEHAVIORAL

STAR-MAP health coaching

BEHAVIORAL

Medication reminder tools

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Conditions

HypertensionMedication AdherenceBehavior and Behavior Mechanisms

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana 70808

United States

Tulane Doctors Dermatology & Multispecialty Clinic

Covington, Louisiana 70433

United States

Tulane Doctors Heart & Vascular and Primary Care Clinic

Metairie, Louisiana 70002

United States

Tulane University Clinical and Translational Unit

New Orleans, Louisiana 70112

United States

LSU Health Sciences Shreveport Clinical Trials Office

Shreveport, Louisiana 71101

United States