Medication Adherence Program

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Tulane University
Study ID
NCT05183763
Status
Recruiting

Conditions

  • Behavior and Behavior Mechanisms
  • Hypertension
  • Medication Adherence

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STAR-MAP health coaching — 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 — BEHAVIORAL
    Medication-taking reminder app and pillbox

Study Details

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.

Key Dates

Start date
Mar 7, 2022
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
402 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

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

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Pennington Biomedical Research CenterBaton RougeLouisiana70808
Erin Peacock
504-988-1075
Tulane Doctors Dermatology & Multispecialty ClinicCovingtonLouisiana70433
Erin Peacock
504-988-1075
Tulane Doctors Heart & Vascular and Primary Care ClinicMetairieLouisiana70002
Erin Peacock
504-988-1075
Tulane University Clinical and Translational UnitNew OrleansLouisiana70112
Erin Peacock
504-988-1075
LSU Health Sciences Shreveport Clinical Trials OfficeShreveportLouisiana71101
Erin Peacock
504-988-1075

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