STAR-MAP health coaching for High Blood Pressure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tulane Doctors Dermatology & Multispecialty Clinic, Covington, LAHigh Blood Pressure+2 MoreSTAR-MAP health coaching - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a health coaching program to see if it helps people with hypertension better manage their blood pressure and take their medication as prescribed.

Eligible Conditions
  • High Blood Pressure
  • Medication Adherence
  • Behavioral Mechanisms

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Dose 1
1
Dose 3
2
Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 24 months

12 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months
Difference in proportion with K-Wood-MAS-4 <1 at 12 months
Difference in proportion with PDC >=0.8 at 12 months
Difference in proportion with controlled BP at 12 months
24 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 24 months
Difference in proportion with K-Wood-MAS-4 <1 at 24 months
Difference in proportion with PDC >=0.8 at 24 months
Difference in proportion with controlled BP at 24 months
6 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 6 months
Difference in proportion with K-Wood-MAS-4 <1 at 6 months
Bronchial Provocation Tests
Baseline to 12 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months
Difference in mean change in DBP, baseline to 12 months
Difference in mean change in K-Wood-MAS-4 score, baseline to 12 months
Difference in mean change in PDC, baseline to 12 months
Difference in mean change in QOL scores, baseline to 12 months
Difference in mean change in SBP, baseline to 12 months
Difference in mean change in health-related quality of life scores, baseline to 12 months
Baseline to 24 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 24 months
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 24 months
Difference in mean change in DBP, baseline to 24 months
Difference in mean change in K-Wood-MAS-4 score, baseline to 24 months
Difference in mean change in PDC, baseline to 24 months
Difference in mean change in QOL scores, baseline to 24 months
Difference in mean change in SBP, baseline to 24 months
Difference in mean change in health-related quality of life scores, baseline to 24 months
Baseline to 6 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 6 months
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 6 months
Difference in mean change in DBP, baseline to 6 months
Difference in mean change in K-Wood-MAS-4 score, baseline to 6 months
Difference in mean change in QOL scores, baseline to 6 months
Difference in mean change in SBP, baseline to 6 months
Difference in mean change in health-related quality of life scores, baseline to 6 months

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
Dose 1
2
Dose 3
3
Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg

Trial Design

2 Treatment Groups

Medication App and Reminder System Medication Adherence Program (MARS-MAP)
1 of 2
STAR-MAP
1 of 2

Active Control

Experimental Treatment

402 Total Participants · 2 Treatment Groups

Primary Treatment: STAR-MAP health coaching · No Placebo Group · N/A

STAR-MAPExperimental Group · 2 Interventions: STAR-MAP health coaching, Medication reminder tools · Intervention Types: Behavioral, Behavioral
Medication App and Reminder System Medication Adherence Program (MARS-MAP)
Behavioral
ActiveComparator Group · 1 Intervention: Medication reminder tools · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Ohio State UniversityOTHER
730 Previous Clinical Trials
469,121 Total Patients Enrolled
Tulane UniversityLead Sponsor
98 Previous Clinical Trials
215,321 Total Patients Enrolled
Minds at WorkUNKNOWN
1 Previous Clinical Trials
36 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,623 Previous Clinical Trials
47,121,365 Total Patients Enrolled
Marie A Krousel-Wood, MD, MSPHPrincipal InvestigatorTulane University

Eligibility Criteria

Age 18+ · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You want to lower your blood pressure.
References

Frequently Asked Questions

What is the sample size of this research project?

"Affirmative. Clinicaltrials.gov details the current search for volunteers, which began on March 7th 2022 and was most recently updated in mid-July of that same year. A total 402 enrollees are sought from four distinct medical sites." - Anonymous Online Contributor

Unverified Answer

How many health care facilities are conducting this experiment?

"At the present, 4 sites are actively enrolling participants in this research study. These locations include Baton Rouge, Metairie, and New Orleans etc., so it is advisable to select a trial site near you for convenience's sake." - Anonymous Online Contributor

Unverified Answer

Is this investigation currently enrolling participants?

"Affirmative. Clinicaltrials.gov confirms that the enrollment for this study is ongoing, having been initiated on March 7th 2022 and updated as recently as July 15th 2022. 402 patients are being sought out from 4 distinct medical venues." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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