Medication Adherence Program

Hypertension Clinical Trial

— MAP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183763
• Other study ID #: 2020-2221
• Secondary ID: R01HL153750
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: April 30, 2027

Study information

• Verified date: April 2024
• Source: Tulane University
• Contact: Erin M Peacock, PhD, MPH
• Phone: 504-988-1075
• Email: epeacoc[@]tulane.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 402
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms
• Hypertension
• Medication Adherence

Intervention

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
• Medication reminder tools
Medication-taking reminder app and pillbox

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Tulane Doctors Dermatology & Multispecialty Clinic	Covington	Louisiana
United States	Tulane Doctors Heart & Vascular and Primary Care Clinic	Metairie	Louisiana
United States	Tulane University Clinical and Translational Unit	New Orleans	Louisiana
United States	LSU Health Sciences Shreveport Clinical Trials Office	Shreveport	Louisiana

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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))	Baseline to 6 months
Other	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))	6 months
Other	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	Baseline to 6 months
Other	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	6 months
Other	Difference in mean change in SBP, baseline to 6 months	Systolic blood pressure (SBP) measured using standardized protocol	Baseline to 6 months
Other	Difference in mean change in DBP, baseline to 6 months	Diastolic blood pressure (DBP) measured using standardized protocol	Baseline to 6 months
Other	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))	Baseline to 6 months
Other	Difference in proportion with PDC >=0.8 at 24 months	Proportion of days covered (PDC) calculated from pharmacy refill data	24 months
Other	Difference in mean change in PDC, baseline to 24 months	Proportion of days covered (PDC) calculated from pharmacy refill data	Baseline to 24 months
Other	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))	Baseline to 24 months
Other	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))	24 months
Other	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	Baseline to 24 months
Other	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	24 months
Other	Difference in mean change in SBP, baseline to 24 months	Systolic blood pressure (SBP) measured using standardized protocol	Baseline to 24 months
Other	Difference in mean change in DBP, baseline to 24 months	Diastolic blood pressure (DBP) measured using standardized protocol	Baseline to 24 months
Other	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))	Baseline to 24 months
Primary	Difference in proportion with PDC >=0.8 at 12 months	Proportion of days covered (PDC) calculated from pharmacy refill data	12 months
Secondary	Difference in mean change in PDC, baseline to 12 months	Proportion of days covered (PDC) calculated from pharmacy refill data	Baseline to 12 months
Secondary	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))	Baseline to 12 months
Secondary	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))	12 months
Secondary	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	Baseline to 12 months
Secondary	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	12 months
Secondary	Difference in mean change in SBP, baseline to 12 months	Systolic blood pressure (SBP) measured using standardized protocol	Baseline to 12 months
Secondary	Difference in mean change in DBP, baseline to 12 months	Diastolic blood pressure (DBP) measured using standardized protocol	Baseline to 12 months
Secondary	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))	Baseline to 12 months