Program to improve medication adherence for hypertension
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
NA · Tulane University · NCT05183763
This study is testing a new program that combines health coaching with medication reminders to help people over 40 with high blood pressure stick to their medications and improve their health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 402 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Tulane University (other) |
| Locations | 5 sites (Baton Rouge, Louisiana and 4 other locations) |
| Trial ID | NCT05183763 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), which combines health coaching with medication reminder tools to enhance adherence to antihypertensive medications. The study will recruit 402 participants aged 40 and older who have uncontrolled hypertension and low medication adherence, randomly assigning them to either the intervention group receiving health coaching or a control group receiving only reminder tools. Data will be collected at multiple time points over two years to assess changes in medication adherence, blood pressure control, and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are English-speaking individuals aged 40 and older, insured by Blue Cross Blue Shield of Louisiana, with uncontrolled hypertension and low adherence to antihypertensive medications.
Not a fit: Patients living with someone already enrolled in the study or those with moderate to severe cognitive impairment may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve medication adherence and blood pressure control in patients with hypertension.
How similar studies have performed: Previous studies have shown promise in using health coaching and reminder tools to improve medication adherence, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baton Rouge, Louisiana and 4 other locations
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (RECRUITING)
- Tulane Doctors Dermatology & Multispecialty Clinic — Covington, Louisiana, United States (RECRUITING)
- Tulane Doctors Heart & Vascular and Primary Care Clinic — Metairie, Louisiana, United States (RECRUITING)
- Tulane University Clinical and Translational Unit — New Orleans, Louisiana, United States (RECRUITING)
- LSU Health Sciences Shreveport Clinical Trials Office — Shreveport, Louisiana, United States (RECRUITING)
Study contacts
- Principal investigator: Marie A Krousel-Wood, MD, MSPH — Tulane University
- Study coordinator: Erin M Peacock, PhD, MPH
- Email: epeacoc@tulane.edu
- Phone: 504-988-1075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Medication Adherence, Behavior and Behavior Mechanisms