MAP: Medication Adherence Program

• Sponsor: Tulane University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05183763
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), Ohio State University (Other), Minds at Work (Other)
• Enrollment: 402
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 49.8
• Patients Per Site: 100.5
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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) >=50 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Medication Adherence; Behavior and Behavior Mechanisms	Behavioral: STAR-MAP health coaching; Behavioral: Medication reminder tools	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 402 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Masking Description: The Data Manager will calculate the primary outcome measure from pharmacy refill data prior to merging with any data file indicating group assignment. BP measurements will be collected by research clinic staff, who will be blinded to 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.
• Primary Purpose: Prevention
• Official 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
• Actual Study Start Date: Mar 7, 2022
• Anticipated Primary Completion Date: Apr 30, 2025
• Anticipated Study Completion Date: Apr 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STAR-MAP Interactive health coaching sessions and medication reminder tools	Behavioral: 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; Behavioral: Medication reminder tools; Medication-taking reminder app and pillbox
Active Comparator: Medication App and Reminder System Medication Adherence Program (MARS-MAP) Medication reminder tools only	Behavioral: Medication reminder tools; Medication-taking reminder app and pillbox

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

   Systolic blood pressure (SBP) measured using standardized protocol

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

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

   Systolic blood pressure (SBP) measured using standardized protocol

6. Difference in mean change in DBP, baseline to 6 months [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 [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 [24 months]

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

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

    Systolic blood pressure (SBP) measured using standardized protocol

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 ≥50 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808
2	Tulane Doctors Dermatology & Multispecialty Clinic	Covington	Louisiana	United States	70433
3	Tulane Doctors Heart & Vascular and Primary Care Clinic	Metairie	Louisiana	United States	70002
4	Tulane University Clinical and Translational Unit	New Orleans	Louisiana	United States	70112

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Marie A Krousel-Wood, MD, MSPH, Tulane University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tulane University
• ClinicalTrials.gov Identifier: NCT05183763
• Other Study ID Numbers: 2020-2221; R01HL153750
• First Posted: Jan 11, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Jul 19, 2022