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
2 other identifiers
interventional
402
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Mar 2022
Longer than P75 for not_applicable hypertension
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedStudy Start
First participant enrolled
March 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
ExpectedMarch 20, 2025
March 1, 2025
4.2 years
December 17, 2021
March 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in proportion with PDC >=0.8 at 12 months
Proportion of days covered (PDC) calculated from pharmacy refill data
12 months
Secondary Outcomes (8)
Difference in mean change in PDC, baseline to 12 months
Baseline to 12 months
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months
Baseline to 12 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months
12 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months
Baseline to 12 months
Difference in proportion with controlled BP at 12 months
12 months
- +3 more secondary outcomes
Other Outcomes (16)
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 6 months
Baseline to 6 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 6 months
6 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 6 months
Baseline to 6 months
- +13 more other outcomes
Study Arms (2)
STAR-MAP
EXPERIMENTALInteractive health coaching sessions and medication reminder tools
Medication App and Reminder System Medication Adherence Program (MARS-MAP)
ACTIVE COMPARATORMedication reminder tools only
Interventions
Interactive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior
Medication-taking reminder app and pillbox
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Tulane Universitylead
- Ohio State Universitycollaborator
- Minds at Workcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (5)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Tulane Doctors Dermatology & Multispecialty Clinic
Covington, Louisiana, 70433, United States
Tulane Doctors Heart & Vascular and Primary Care Clinic
Metairie, Louisiana, 70002, United States
Tulane University Clinical and Translational Unit
New Orleans, Louisiana, 70112, United States
LSU Health Sciences Shreveport Clinical Trials Office
Shreveport, Louisiana, 71101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie A Krousel-Wood, MD, MSPH
Tulane University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- The Data Manager will calculate the primary outcome measure from pharmacy refill data prior to merging with any data file indicating group assignment. Laboratory technicians who perform the liquid chromatography tandem mass spectrometry analysis of urine metabolites of antihypertensive medications will also be blinded to group assignment. Finally, participants' primary care providers will be notified of their patients' enrollment into the study but will not be given information about group assignment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2021
First Posted
January 11, 2022
Study Start
March 7, 2022
Primary Completion
April 30, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
March 20, 2025
Record last verified: 2025-03