Medication Adherence Program

NCT ID: NCT05183763

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Medication Adherence Behavior and Behavior Mechanisms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
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.

Study Groups

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STAR-MAP

Interactive health coaching sessions and medication reminder tools

Group Type EXPERIMENTAL

STAR-MAP health coaching

Intervention Type BEHAVIORAL

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

Medication reminder tools

Intervention Type BEHAVIORAL

Medication-taking reminder app and pillbox

Medication App and Reminder System Medication Adherence Program (MARS-MAP)

Medication reminder tools only

Group Type ACTIVE_COMPARATOR

Medication reminder tools

Intervention Type BEHAVIORAL

Medication-taking reminder app and pillbox

Interventions

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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

Intervention Type BEHAVIORAL

Medication reminder tools

Medication-taking reminder app and pillbox

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role collaborator

Minds at Work

UNKNOWN

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Tulane University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie A Krousel-Wood, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Tulane Doctors Dermatology & Multispecialty Clinic

Covington, Louisiana, United States

Site Status RECRUITING

Tulane Doctors Heart & Vascular and Primary Care Clinic

Metairie, Louisiana, United States

Site Status RECRUITING

Tulane University Clinical and Translational Unit

New Orleans, Louisiana, United States

Site Status RECRUITING

LSU Health Sciences Shreveport Clinical Trials Office

Shreveport, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin M Peacock, PhD, MPH

Role: CONTACT

504-988-1075

Marie A Krousel-Wood, MD, MSPH

Role: CONTACT

504-988-7056

Facility Contacts

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Erin Peacock

Role: primary

504-988-1075

Erin Peacock

Role: primary

504-988-1075

Erin Peacock

Role: primary

504-988-1075

Erin Peacock

Role: primary

504-988-1075

Erin Peacock

Role: primary

504-988-1075

Other Identifiers

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R01HL153750

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-2221

Identifier Type: -

Identifier Source: org_study_id

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