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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
Louisiana
Pennington Biomedical Research Center
RECRUITING
Baton Rouge
Tulane Doctors Dermatology & Multispecialty Clinic
RECRUITING
Covington
Tulane Doctors Heart & Vascular and Primary Care Clinic
RECRUITING
Metairie
Tulane University Clinical and Translational Unit
RECRUITING
New Orleans
LSU Health Sciences Shreveport Clinical Trials Office
RECRUITING
Shreveport
Contact Information
Primary
Erin M Peacock, PhD, MPH
epeacoc@tulane.edu
504-988-1075
Backup
Marie A Krousel-Wood, MD, MSPH
mawood@tulane.edu
504-988-7056
Time Frame
Start Date: 2022-03-07
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 402
Treatments
Experimental: STAR-MAP
Interactive health coaching sessions and medication reminder tools
Active_comparator: Medication App and Reminder System Medication Adherence Program (MARS-MAP)
Medication reminder tools only
Related Therapeutic Areas
Sponsors
Collaborators: Minds at Work, Ohio State University, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Tulane University

This content was sourced from clinicaltrials.gov