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NCT Number: NCT05183763

Medication Adherence Program

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.

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Key information

Conditions

Hypertension Behavior Behavior and Behavior Mechanisms Cardiovascular Diseases Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Difference in proportion with PDC >=0.8 at 12 months

    Time frame: 12 months

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

Secondary outcomes

  1. Difference in mean change in PDC, baseline to 12 months

    Time frame: Baseline to 12 months

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

  2. Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months

    Time frame: 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))

  3. Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months

    Time frame: 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))

  4. Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months

    Time frame: Baseline to 12 months

    Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications

  5. Difference in proportion with controlled BP at 12 months

    Time frame: 12 months

    Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol

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

    Time frame: Baseline to 12 months

    Systolic blood pressure (SBP) measured using standardized protocol

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

    Time frame: Baseline to 12 months

    Diastolic blood pressure (DBP) measured using standardized protocol

  8. Difference in mean change in health-related quality of life scores, baseline to 12 months

    Time frame: 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))

Other outcomes

  1. Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 6 months

    Time frame: 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))

  2. Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 6 months

    Time frame: 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))

  3. Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 6 months

    Time frame: Baseline to 6 months

    Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications

  4. Difference in proportion with controlled BP at 6 months

    Time frame: 6 months

    Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol

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

    Time frame: Baseline to 6 months

    Systolic blood pressure (SBP) measured using standardized protocol

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

    Time frame: Baseline to 6 months

    Diastolic blood pressure (DBP) measured using standardized protocol

  7. Difference in mean change in health-related quality of life scores, baseline to 6 months

    Time frame: 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))

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

    Time frame: 24 months

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

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

    Time frame: Baseline to 24 months

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

  10. Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 24 months

    Time frame: 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))

  11. Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 24 months

    Time frame: 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))

  12. Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 24 months

    Time frame: Baseline to 24 months

    Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications

  13. Difference in proportion with controlled BP at 24 months

    Time frame: 24 months

    Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol

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

    Time frame: Baseline to 24 months

    Systolic blood pressure (SBP) measured using standardized protocol

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

    Time frame: Baseline to 24 months

    Diastolic blood pressure (DBP) measured using standardized protocol

  16. Difference in mean change in health-related quality of life scores, baseline to 24 months

    Time frame: 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))

Study contacts

Contact information is provided by the study sponsor or research team.

Erin M Peacock, PhD, MPH

CONTACT

[email protected]

504-988-1075

Marie A Krousel-Wood, MD, MSPH

CONTACT

[email protected]

504-988-7056

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • Minds at Work
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Ohio State University

Registry information

Official study title

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

Acronym: MAP

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 11, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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