Medication Adherence Program (MAP)

Tulane University

Status: Enrolling

Conditions: Hypertension; Medication Adherence; Behavior and Behavior Mechanisms

Treatments: Behavioral: Medication reminder tools; Behavioral: STAR-MAP health coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05183763

R01HL153750 (U.S. NIH Grant/Contract)

2020-2221

Details and patient eligibility

About

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.

Enrollment: 402 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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402 participants in 2 patient groups

STAR-MAP

Experimental group

Description:

Interactive health coaching sessions and medication reminder tools

Treatment:

Behavioral: STAR-MAP health coaching

Behavioral: Medication reminder tools

Medication App and Reminder System Medication Adherence Program (MARS-MAP)

Active Comparator group

Description:

Medication reminder tools only

Treatment:

Behavioral: Medication reminder tools