RecruitingNot Applicable

Medication Adherence Program

United States402 participantsStarted 2022-03-07

Plain-language 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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focuses on improving how consistently patients take their blood pressure medications over 12 months — can you explain what my current medication adherence looks like and whether this kind of program might actually help me specifically?
2The trial is measuring something called PDC, or proportion of days covered, as the main outcome — can you help me understand what my PDC currently is and what reaching 0.8 or above would mean for my blood pressure management?
3Since this is listed as Phase NA, which typically means it's a behavioral or systems-based study rather than a drug trial, can you walk me through what the program would actually require me to do day-to-day and whether that fits realistically with my schedule?
4Are there standard tools or support programs already available outside of this trial — like pharmacist check-ins, pill reminders, or medication synchronization — that might help me with adherence without enrolling in a study?
5Given that this trial is still recruiting, what do you know about how the adherence intervention in this study works, and do you think it's a better fit for where I am in my hypertension treatment compared to just adjusting my current care plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in proportion with PDC >=0.8 at 12 months

Timeframe: 12 months

Trial details

NCT IDNCT05183763

SponsorTulane University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Erin M Peacock, PhD, MPH

504-988-1075 epeacoc@tulane.edu

View on ClinicalTrials.gov More Hypertension trials