What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for high blood pressure include ACE inhibitors, ARBs, calcium channel blockers, thiazide diuretics, and beta blockers. ACE inhibitors and ARBs can cause side effects like cough, elevated blood potassium levels, and kidney dysfunction. Calcium channel blockers may lead to swelling, dizziness, and constipation. Thiazide diuretics can result in electrolyte imbalances, such as low sodium or potassium levels, and may increase the risk of gout. Beta blockers can cause fatigue, cold extremities, and may affect blood sugar levels. Patients should discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several classes of medications for the treatment of high blood pressure, including ACE inhibitors (e.g., enalapril, lisinopril), angiotensin receptor blockers (ARBs) (e.g., losartan, valsartan), thiazide diuretics (e.g., hydrochlorothiazide), and calcium channel blockers (CCBs) (e.g., amlodipine). These medications are often used in combination to achieve better blood pressure control. The STAR-MAP trial, which focuses on health coaching to improve medication adherence, includes these types of antihypertensive drugs, highlighting their importance in managing hypertension effectively.

What other types of research exist?

Promising alternatives to STAR-MAP for improving medication adherence in high blood pressure patients include: 1) Digital health interventions such as mobile apps and telemonitoring systems that provide reminders and track medication use. 2) Fixed-dose combination pills that simplify treatment regimens and improve adherence. 3) Personalized behavioral interventions that use data analytics to tailor support to individual patient needs. 4) Pharmacist-led medication management programs that offer personalized counseling and follow-up. 5) Use of artificial intelligence and machine learning to predict and address adherence barriers.

← Back to Search

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

No Placebo-Only Group

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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 more

Other 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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 5Eligibility criteria met

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.