| NCT ID | NCT05183763 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tulane University |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 402 participants |
| Start Date | 2022-03-07 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 402 participants in total. It began in 2022-03-07 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Marie A Krousel-Wood, MD, MSPH
PRINCIPAL INVESTIGATOR
Tulane University
Frequently Asked Questions
Who can join the NCT05183763 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05183763 currently recruiting?
Yes, NCT05183763 is actively recruiting participants. Contact the research team at epeacoc@tulane.edu for enrollment information.
Where is the NCT05183763 trial being conducted?
This trial is being conducted at Baton Rouge, United States, Covington, United States, Metairie, United States, New Orleans, United States and 1 additional location.
Who is sponsoring the NCT05183763 clinical trial?
NCT05183763 is sponsored by Tulane University. The principal investigator is Marie A Krousel-Wood, MD, MSPH at Tulane University. The trial plans to enroll 402 participants.