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Active, not recruitingNCT05183763MAPUpdated Oct 1, 2026

Medication Adherence Program

An interventional study of STAR-MAP health coaching and Medication reminder tools in Hypertension, Medication Adherence and Behavior and Behavior Mechanisms, sponsored by Tulane University. Active, not recruiting at 5 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Tulane University · Not applicable, Interventional, and Prevention

Updated Oct 1, 2026Now Active, not recruitingGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
402
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension
  • Medication Adherence
  • Behavior and Behavior Mechanisms
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 402 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Tulane University is the lead sponsor of 96 studies on the registry; 23 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
402 participants (estimated)

Study arms

  • Experimental
    STAR-MAP

    Interactive health coaching sessions and medication reminder tools

    Behavioral: STAR-MAP health coaching · Behavioral: Medication reminder tools

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

    Medication reminder tools only

    Behavioral: Medication reminder tools

Interventions

  • BehavioralSTAR-MAP health coaching

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

  • BehavioralMedication reminder tools

    Medication-taking reminder app and pillbox

06

What researchers measure

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 months

Secondary 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 months

  2. 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 months

  3. 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 months

  4. 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 months

  5. 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

    Time frame: 12 months

  6. Difference in mean change in SBP, baseline to 12 months

    Systolic blood pressure (SBP) measured using standardized protocol

    Time frame: Baseline to 12 months

  7. Difference in mean change in DBP, baseline to 12 months

    Diastolic blood pressure (DBP) measured using standardized protocol

    Time frame: Baseline to 12 months

  8. 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))

    Time frame: Baseline to 12 months

Other 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 months

  2. 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 months

  3. 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 months

  4. 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 months

  5. Difference in mean change in SBP, baseline to 6 months

    Systolic blood pressure (SBP) measured using standardized protocol

    Time frame: Baseline to 6 months

  6. Difference in mean change in DBP, baseline to 6 months

    Diastolic blood pressure (DBP) measured using standardized protocol

    Time frame: Baseline to 6 months

  7. 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))

    Time frame: Baseline to 6 months

  8. Difference in proportion with PDC >=0.8 at 24 months

    Proportion of days covered (PDC) calculated from pharmacy refill data

    Time frame: 24 months

  9. Difference in mean change in PDC, baseline to 24 months

    Proportion of days covered (PDC) calculated from pharmacy refill data

    Time frame: Baseline to 24 months

  10. 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))

    Time frame: Baseline to 24 months

  11. 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))

    Time frame: 24 months

  12. 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

    Time frame: Baseline to 24 months

  13. 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

    Time frame: 24 months

  14. Difference in mean change in SBP, baseline to 24 months

    Systolic blood pressure (SBP) measured using standardized protocol

    Time frame: Baseline to 24 months

  15. Difference in mean change in DBP, baseline to 24 months

    Diastolic blood pressure (DBP) measured using standardized protocol

    Time frame: Baseline to 24 months

  16. 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))

    Time frame: Baseline to 24 months

07

Study locations

5 sites
  • 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
08

References and documents

Publications

  • Peacock E, Mohundro B, Li J, Bazzano L, Shankar A, Petty R, Kegan R, Krousel-Wood M. Supporting tailored adaptive change and reinforcement for medication adherence program (STAR-MAP): Rationale and design of a randomized controlled clinical trial. Contemp Clin Trials. 2026 Jul;166:108353. doi: 10.1016/j.cct.2026.108353. Epub 2026 May 22. PubMed 42173438 ↗
09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Recruiting→Active, not recruiting
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05183763
Lead sponsor
Tulane University
Responsible party
Sponsor
First posted
Jan 11, 2022
Start date
Mar 7, 2022
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Oct 1, 2026

Study contacts

Marie A Krousel-Wood, MD, MSPH
principal investigator · Tulane University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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