Recruiting

Medication Adherence

Sponsor:

Tulane University

Code:

NCT05183763

Conditions

Hypertension

Medication Adherence

Behavior and Behavior Mechanisms

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

STAR-MAP health coaching

Medication reminder tools

Study Details

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.

Conditions

Hypertension

Medication Adherence

Behavior and Behavior Mechanisms

Study ID

NCT05183763

Start date

Mar 7, 2022

Status verified date

Jun, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

402 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

STAR-MAP health coaching

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

Medication reminder tools

Medication-taking reminder app and pillbox

Primary outcome measure

  • Difference in proportion with PDC >=0.8 at 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Erin M Peacock, PhD, MPH

504-988-1075epeacoc@tulane.edu

Marie A Krousel-Wood, MD, MSPH

504-988-7056mawood@tulane.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Erin Peacock

504-988-1075epeacoc@tulane.edu

Tulane Doctors Dermatology & Multispecialty Clinic

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Erin Peacock

504-988-1075epeacoc@tulane.edu

Tulane Doctors Heart & Vascular and Primary Care Clinic

Recruiting

Metairie, Louisiana, United States, 70002

Contacts

Erin Peacock

504-988-1075epeacoc@tulane.edu

Tulane University Clinical and Translational Unit

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Erin Peacock

504-988-1075epeacoc@tulane.edu

LSU Health Sciences Shreveport Clinical Trials Office

Recruiting

Shreveport, Louisiana, United States, 71101

Contacts

Erin Peacock

504-988-1075epeacoc@tulane.edu

More Information

Sponsor

Tulane University

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2026-06-12.