Medication Adherence Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorTulane University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
STAR-MAP health coaching
BehavioralInteractive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior
Medication reminder tools
BehavioralMedication-taking reminder app and pillbox
Treatment groups
402 Participants
are divided into 2 treatment groupsGroup A: STAR-MAPExperimental treatment 2 interventions
Group B: Medication App and Reminder System Medication Adherence Program (MARS-MAP)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in proportion with PDC >=0.8 at 12 months
Proportion of days covered (PDC) calculated from pharmacy refill data
Time frame
12 monthsSecondary outcomes
1
Difference in mean change in PDC, baseline to 12 months
Proportion of days covered (PDC) calculated from pharmacy refill data
Time frame
Baseline to 12 months2
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))
Time frame
Baseline to 12 months3
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))
Time frame
12 months4
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
Time frame
Baseline to 12 monthsOther outcomes
1
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))
Time frame
Baseline to 6 months2
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))
Time frame
6 months3
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
Time frame
Baseline to 6 months4
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
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tulane University
Lead sponsor
Ohio State University
Collaborator
Minds at Work
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov