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Health Coaching + Medication Reminders for High Blood Pressure (MAP Trial)
N/A
Recruiting
Led By Marie A Krousel-Wood, MD, MSPH
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fully insured by Blue Cross Blue Shield of Louisiana (BCBSLA)
Currently filling antihypertensive medication
Must not have
Moderate to severe cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Summary
This trial tests a health coaching program called STAR-MAP, which helps people aged 50+ with uncontrolled high blood pressure take their medication regularly. The program uses personalized coaching and reminders to improve medication adherence and promote healthier habits.
Who is the study for?
This trial is for people over 50 with high blood pressure who struggle to stick to their medication schedule. They must be insured by Blue Cross Blue Shield of Louisiana, plan to stay with them next year, speak English, have a phone, and not live with someone in the study or be in another drug adherence trial.
What is being tested?
The STAR-MAP program's effectiveness is being tested against just using medication reminder tools. The program includes health coaching sessions aimed at improving how well participants take their blood pressure medicine and manage their condition.
What are the potential side effects?
Since this trial focuses on health coaching and reminders rather than new medications, side effects are minimal but may include discomfort from discussing personal habits or frustration if no improvement in medication adherence is seen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully insured by Blue Cross Blue Shield of Louisiana.
Select...
I am currently taking medication for high blood pressure.
Select...
I have been diagnosed with high blood pressure.
Select...
I am 50 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have significant memory or thinking problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in proportion with PDC >=0.8 at 12 months
Secondary study objectives
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
+5 moreOther study objectives
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 24 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 24 months
+13 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: STAR-MAPExperimental Treatment2 Interventions
Interactive health coaching sessions and medication reminder tools
Group II: Medication App and Reminder System Medication Adherence Program (MARS-MAP)Active Control1 Intervention
Medication reminder tools only
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for high blood pressure include ACE inhibitors, ARBs, beta-blockers, calcium channel blockers, and diuretics. ACE inhibitors and ARBs work by inhibiting the renin-angiotensin system, which helps relax blood vessels.
Beta-blockers reduce heart rate and the force of contraction, lowering blood pressure. Calcium channel blockers prevent calcium from entering heart and blood vessel cells, leading to relaxed vessels.
Diuretics help the kidneys remove excess sodium and water, reducing blood volume. These mechanisms are crucial for managing high blood pressure, as they directly target the physiological factors contributing to elevated blood pressure.
Effective medication adherence, as promoted in the STAR-MAP trial, ensures these treatments can consistently control blood pressure, reducing the risk of cardiovascular events.
Determinants of hypertension treatment adherence among a Chinese population using the therapeutic adherence scale for hypertensive patients.Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30-60 years: study protocol for a randomized controlled trial.Understanding the quality chasm for hypertension control in diabetes: a structured review of "co-maneuvers" used in clinical trials.
Determinants of hypertension treatment adherence among a Chinese population using the therapeutic adherence scale for hypertensive patients.Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30-60 years: study protocol for a randomized controlled trial.Understanding the quality chasm for hypertension control in diabetes: a structured review of "co-maneuvers" used in clinical trials.
Find a Location
Who is running the clinical trial?
Tulane UniversityLead Sponsor
121 Previous Clinical Trials
238,698 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,909 Previous Clinical Trials
47,755,916 Total Patients Enrolled
Ohio State UniversityOTHER
863 Previous Clinical Trials
653,958 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You live with someone who is already in the study.I have significant memory or thinking problems.You are currently participating in another clinical trial for medication adherence or blood pressure control.You do not consistently take your medication as prescribed.I am fully insured by Blue Cross Blue Shield of Louisiana.I want to lower my blood pressure.Your blood pressure is not under control (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg).I often forget to take or refill my blood pressure medication.I am currently taking medication for high blood pressure.I have been diagnosed with high blood pressure.I am 50 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: STAR-MAP
- Group 2: Medication App and Reminder System Medication Adherence Program (MARS-MAP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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