RecruitingNot ApplicableNCT05183763

Medication Adherence Program

Supporting Tailored Adaptive Change and Reinforcement for Medication Adherence Program: Randomized Trial of a Novel Approach to Improve Adherence in Older Hypertensive Women and Men


Sponsor

Tulane University

Enrollment

402 participants

Start Date

Mar 7, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a phone-based medication adherence program to help people with high blood pressure take their blood pressure medications more consistently, with the goal of better controlling their blood pressure. **You may be eligible if:** - You are 40 years or older - You are fully insured by Blue Cross Blue Shield of Louisiana and have been continuously enrolled for at least one year - You have a diagnosis of essential high blood pressure - You are currently filling a blood pressure medication prescription but not taking it consistently (proportion of days covered below 80%) - Your blood pressure is not well controlled (systolic 130+ or diastolic 80+ mmHg) - You speak English and have access to a phone - You want to improve your blood pressure **You may NOT be eligible if:** - Someone else in your household is already enrolled in this study - You are currently enrolled in another clinical trial for medication adherence or blood pressure control - You have moderate to severe cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSTAR-MAP health coaching

Interactive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior

BEHAVIORALMedication reminder tools

Medication-taking reminder app and pillbox


Locations(5)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Tulane Doctors Dermatology & Multispecialty Clinic

Covington, Louisiana, United States

Tulane Doctors Heart & Vascular and Primary Care Clinic

Metairie, Louisiana, United States

Tulane University Clinical and Translational Unit

New Orleans, Louisiana, United States

LSU Health Sciences Shreveport Clinical Trials Office

Shreveport, Louisiana, United States

View Full Details on ClinicalTrials.gov

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NCT05183763


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