Medication Adherence Program (MAP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Medication Adherence; Behavior and Behavior Mechanisms
• Intervention / Treatment: Behavioral: STAR-MAP health coaching; Behavioral: Medication reminder tools

• Study Type: Interventional
• Enrollment (Estimated): 402
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin M Peacock, PhD, MPH; Phone Number: 504-988-1075; Email: epeacoc@tulane.edu
• Study Contact Backup: Name: Marie A Krousel-Wood, MD, MSPH; Phone Number: 504-988-7056; Email: mawood@tulane.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Pennington Biomedical Research Center
      • Contact: Erin Peacock; Phone Number: 504-988-1075; Email: epeacoc@tulane.edu
    • Covington, Louisiana, United States, 70433
      • Recruiting
      • Tulane Doctors Dermatology & Multispecialty Clinic
      • Contact: Erin Peacock; Phone Number: 504-988-1075; Email: epeacoc@tulane.edu
    • Metairie, Louisiana, United States, 70002
      • Recruiting
      • Tulane Doctors Heart & Vascular and Primary Care Clinic
      • Contact: Erin Peacock; Phone Number: 504-988-1075; Email: epeacoc@tulane.edu
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Tulane University Clinical and Translational Unit
      • Contact: Erin Peacock; Phone Number: 504-988-1075; Email: epeacoc@tulane.edu
    • Shreveport, Louisiana, United States, 71101
      • Recruiting
      • LSU Health Sciences Shreveport Clinical Trials Office
      • Contact: Erin Peacock; Phone Number: 504-988-1075; Email: epeacoc@tulane.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STAR-MAP; Interactive health coaching sessions and medication reminder tools	Behavioral: 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; Behavioral: Medication reminder tools; Medication-taking reminder app and pillbox
Active Comparator: Medication App and Reminder System Medication Adherence Program (MARS-MAP); Medication reminder tools only	Behavioral: Medication reminder tools; Medication-taking reminder app and pillbox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in proportion with PDC >=0.8 at 12 months	Proportion of days covered (PDC) calculated from pharmacy refill data	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in mean change in PDC, baseline to 12 months	Proportion of days covered (PDC) calculated from pharmacy refill data	Baseline to 12 months
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months	Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))	Baseline to 12 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months	Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))	12 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months	Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications	Baseline to 12 months
Difference in proportion with controlled BP at 12 months	Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol	12 months
Difference in mean change in SBP, baseline to 12 months	Systolic blood pressure (SBP) measured using standardized protocol	Baseline to 12 months
Difference in mean change in DBP, baseline to 12 months	Diastolic blood pressure (DBP) measured using standardized protocol	Baseline to 12 months
Difference in mean change in health-related quality of life scores, baseline to 12 months	Quality of life measured using 12-item Short Form Survey (SF-12); scores for eight subscales, Mental Component Summary, and Physical Component Summary calculated and compared (minimum: 0 (worse quality of life); maximum: 100 (better quality of life))	Baseline to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 6 months	Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))	Baseline to 6 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 6 months	Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))	6 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 6 months	Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications	Baseline to 6 months
Difference in proportion with controlled BP at 6 months	Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol	6 months
Difference in mean change in SBP, baseline to 6 months	Systolic blood pressure (SBP) measured using standardized protocol	Baseline to 6 months
Difference in mean change in DBP, baseline to 6 months	Diastolic blood pressure (DBP) measured using standardized protocol	Baseline to 6 months
Difference in mean change in health-related quality of life scores, baseline to 6 months	Quality of life measured using 12-item Short Form Survey (SF-12); scores for eight subscales, Mental Component Summary, and Physical Component Summary calculated and compared (minimum: 0 (worse quality of life); maximum: 100 (better quality of life))	Baseline to 6 months
Difference in proportion with PDC >=0.8 at 24 months	Proportion of days covered (PDC) calculated from pharmacy refill data	24 months
Difference in mean change in PDC, baseline to 24 months	Proportion of days covered (PDC) calculated from pharmacy refill data	Baseline to 24 months
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 24 months	Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))	Baseline to 24 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 24 months	Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))	24 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 24 months	Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications	Baseline to 24 months
Difference in proportion with controlled BP at 24 months	Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol	24 months
Difference in mean change in SBP, baseline to 24 months	Systolic blood pressure (SBP) measured using standardized protocol	Baseline to 24 months
Difference in mean change in DBP, baseline to 24 months	Diastolic blood pressure (DBP) measured using standardized protocol	Baseline to 24 months
Difference in mean change in health-related quality of life scores, baseline to 24 months	Quality of life measured using 12-item Short Form Survey (SF-12); scores for eight subscales, Mental Component Summary, and Physical Component Summary calculated and compared (minimum: 0 (worse quality of life); maximum: 100 (better quality of life))	Baseline to 24 months

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Ohio State University; Minds at Work
• Investigators: Principal Investigator: Marie A Krousel-Wood, MD, MSPH, Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Hypertension; Behavior; Medication Adherence
• Other Study ID Numbers: 2020-2221; R01HL153750 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No