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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL153750 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Ohio State University | OTHER |
| Minds at Work | UNKNOWN |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STAR-MAP | Experimental | Interactive health coaching sessions and medication reminder tools |
|
| Medication App and Reminder System Medication Adherence Program (MARS-MAP) | Active Comparator | Medication reminder tools only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in proportion with PDC >=0.8 at 12 months | Proportion of days covered (PDC) calculated from pharmacy refill data | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean change in PDC, baseline to 12 months | Proportion of days covered (PDC) calculated from pharmacy refill data | Baseline to 12 months |
| Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin M Peacock, PhD, MPH | Contact | 504-988-1075 | epeacoc@tulane.edu | |
| Marie A Krousel-Wood, MD, MSPH | Contact | 504-988-7056 | mawood@tulane.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marie A Krousel-Wood, MD, MSPH | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Recruiting | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42173438 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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The Data Manager will calculate the primary outcome measure from pharmacy refill data prior to merging with any data file indicating 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.
| Medication reminder tools | Behavioral | Medication-taking reminder app and pillbox |
|
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 |
| 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 |
| 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 |
| 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 |
| Difference in mean change in SBP, baseline to 12 months | Systolic blood pressure (SBP) measured using standardized protocol | Baseline to 12 months |
| Difference in mean change in DBP, baseline to 12 months | Diastolic blood pressure (DBP) measured using standardized protocol | Baseline to 12 months |
| 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 |
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 |
| 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 |
| 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 |
| Difference in mean change in SBP, baseline to 6 months | Systolic blood pressure (SBP) measured using standardized protocol | Baseline to 6 months |
| Difference in mean change in DBP, baseline to 6 months | Diastolic blood pressure (DBP) measured using standardized protocol | Baseline to 6 months |
| 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 |
| Difference in proportion with PDC >=0.8 at 24 months | Proportion of days covered (PDC) calculated from pharmacy refill data | 24 months |
| Difference in mean change in PDC, baseline to 24 months | Proportion of days covered (PDC) calculated from pharmacy refill data | Baseline to 24 months |
| 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 |
| 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 |
| 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 |
| 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 |
| Difference in mean change in SBP, baseline to 24 months | Systolic blood pressure (SBP) measured using standardized protocol | Baseline to 24 months |
| Difference in mean change in DBP, baseline to 24 months | Diastolic blood pressure (DBP) measured using standardized protocol | Baseline to 24 months |
| 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 |
| Tulane Doctors Dermatology & Multispecialty Clinic | Recruiting | Covington | Louisiana | 70433 | United States |
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| Tulane Doctors Heart & Vascular and Primary Care Clinic | Recruiting | Metairie | Louisiana | 70002 | United States |
|
| Tulane University Clinical and Translational Unit | Recruiting | New Orleans | Louisiana | 70112 | United States |
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| LSU Health Sciences Shreveport Clinical Trials Office | Recruiting | Shreveport | Louisiana | 71101 | United States |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |