Health Coaching + Medication Reminders for High Blood Pressure

(MAP Trial)

Recruiting at 4 trial locations

Overseen By Marie A Krousel-Wood, MD, MSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Must be taking: Antihypertensives

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 12 months

402 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether the STAR-MAP health coaching program can help people with high blood pressure adhere to their medication and improve their overall health. Participants will either receive one-on-one coaching sessions with medication reminders or just the reminders. The research will assess whether these approaches help control blood pressure and enhance quality of life. Individuals struggling to manage their blood pressure and frequently missing medication doses might be suitable for this study. Participants must be insured by Blue Cross Blue Shield of Louisiana and have phone access. As an unphased study, this trial offers a unique opportunity for participants to contribute to innovative health coaching strategies that could improve medication adherence and overall well-being.

Do I need to stop my current medications for this trial?

The trial does not specify that you need to stop taking your current medications. In fact, it seems to focus on helping you stick to your current antihypertensive medication routine.

What prior data suggests that this health coaching approach is safe for improving medication adherence?

Research has shown that health coaching, such as the STAR-MAP program, is generally safe. In past studies, participants responded well to health coaching, with most experiencing no negative effects. This program aids in medication adherence and better health management. No reports of harmful side effects from health coaching itself exist. Participants often find these programs helpful and supportive. Discussing any concerns with a healthcare provider before joining a clinical trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STAR-MAP health coaching approach for high blood pressure because it combines interactive health coaching with medication reminders, offering a personalized touch that goes beyond typical medication alone. Unlike standard treatments that primarily focus on medication to manage blood pressure, STAR-MAP emphasizes behavioral change through coaching, which empowers patients to adopt healthier lifestyle habits alongside their medication regimen. This dual approach not only aims to improve adherence to medication schedules but also encourages a holistic approach to managing high blood pressure, potentially leading to more sustainable health outcomes.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research has shown that health coaching can help people take their medication as prescribed. In this trial, the STAR-MAP program offers personalized coaching and reminders to assist individuals in taking their blood pressure medicine regularly. Studies have found that patients who received this support managed their blood pressure better and experienced an improved quality of life. Another arm of this trial, MARS-MAP, uses only medication reminder tools. Both approaches aim to lower high blood pressure by promoting consistent medication use, with STAR-MAP focusing on coaching and reminder tools to encourage lasting habits. ^{2 3 4 6 7}

Who Is on the Research Team?

Marie A Krousel-Wood, MD, MSPH

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You do not consistently take your medication as prescribed.

Continuously enrolled in BCBSLA for one year

Planning to remain a member of BCBSLA for next year

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either interactive health coaching sessions with medication reminder tools or medication reminder tools only

12 months

Visits at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visit at 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Medication reminder tools
• STAR-MAP health coaching

Trial Overview 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.

How Is the Trial Designed?

Group I: STAR-MAP Experimental Treatment 2 Interventions

Interactive health coaching sessions and medication reminder tools

Group II: Medication App and Reminder System Medication Adherence Program (MARS-MAP) Active Control 1 Intervention

Medication reminder tools only

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Minds at Work

Collaborator

Trials

2

Recruited

440+

Published Research Related to This Trial

Long-term adherence to antihypertensive medications is generally poor, highlighting the need for new strategies to improve patient compliance with prescribed drug regimens.

Behavior change principles can effectively enhance medication adherence by tailoring interventions to a patient's stage of change, with techniques like rewards and reminders being most effective for those ready to change, while earlier-stage patients benefit from awareness-raising interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior-changing methods for improving adherence to medication. Willey, C.[2019]

In a 12-month study involving 182 adult patients with coronary disease, personalized behavioral nudges significantly increased statin adherence, with a proportion of days covered (PDC) of 0.742 in the nudge group compared to 0.639 in the control group (P = 0.042).

The nudge group also had a higher percentage of adherent subjects (66.3% with PDC ≥80%) compared to controls (50.5%, P = 0.036), indicating that AI-driven nudges can effectively enhance medication adherence without significant differences in serious health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Nudges as Patient Decision Support for Medication Adherence: The ENCOURAGE Randomized Controlled Trial. Horne, BD., Muhlestein, JB., Lappé, DL., et al.[2022]

Text message reminders (TMR) significantly improved medication adherence among 1678 patients with coronary heart disease, showing a 2.85 times greater adherence rate compared to the control group.

TMR also led to notable reductions in systolic blood pressure and cholesterol levels, contributing to better clinical outcomes, although it did not affect mortality or diastolic blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of text message reminders on medication adherence among patients with coronary heart disease: A systematic review and meta-analysis. Zhao, YY., Dang, FP., Zhai, TT., et al.[2022]

Patients referred to health coaching by their physician were much more likely to enroll (21.0% vs 6.0%) and complete the program (8.5% vs 2.7%) compared to those identified through insurer outreach, highlighting the importance of physician involvement in patient engagement.

Both groups showed significant improvements in health risk levels after health coaching, indicating that health coaching can effectively reduce health risks regardless of the referral source, but physician referrals greatly enhance participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Physician Referral to Health Coaching on Patient Engagement and Health Risks: An Observational Study of UPMC's Prescription for Wellness. Parkinson, MD., Hammonds, T., Keyser, DJ., et al.[2021]

A health-coaching intervention significantly improved medication adherence among 477 patients with hypertension, leading to an increase in adherence scores from 5.75 to 5.94 (P = .04).

The intervention also resulted in a notable decrease in diastolic blood pressure from 81.6 to 76.1 mm Hg (P < .001), with improvements in medication adherence being linked to these reductions in blood pressure over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a practice-based multicomponent intervention that includes health coaching on medication adherence and blood pressure control in rural primary care. Wu, JR., Cummings, DM., Li, Q., et al.[2021]

In a study of 2670 adult outpatients, patient recall of health behavior discussions with physicians varied significantly, with only 11% recalling substance use assessments compared to 75% recalling smoking cessation advice.

Longer discussions about diet and exercise led to better recall, and patients were more likely to remember health advice given during well care visits or when a relevant health issue was addressed during illness visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct observation and patient recall of health behavior advice. Flocke, SA., Stange, KC.[2023]

In a study involving 25 uninsured hypertensive patients, the use of trained student health coaches led to a significant increase in medication adherence and a notable reduction in systolic blood pressure by 11 mmHg.

Qualitative feedback indicated high patient satisfaction with the coaching intervention, suggesting that this model could be a feasible approach to improve blood pressure management in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach to antihypertensive adherence: a feasibility study on the use of student health coaches for uninsured hypertensive adults. Leung, LB., Busch, AM., Nottage, SL., et al.[2021]

Pharmacist health coaching significantly improved medication management and exercise behaviors in 20 participants with poorly controlled hypertension, leading to a notable decrease in systolic blood pressure by 7.53 mmHg over four months.

Participants receiving health coaching showed better medication adherence, with scores on the Adherence to Refills and Medications Scale decreasing from 15.60 to 13.05, while the control group did not experience significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pharmacist health coaching trial evaluating behavioural changes in participants with poorly controlled hypertension. Singh, HK., Kennedy, GA., Stupans, I.[2022]

A systematic review of 11 studies found that using health behavioral models, like the Self-Regulation Model and Social Cognitive Theory, can potentially improve medication adherence in adults with hypertension, with two studies showing significant improvements.

Despite some positive results, the overall effectiveness of these interventions remains unclear, highlighting the need for more rigorously designed studies that effectively apply these health behavioral models to enhance adherence to antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of interventions using health behavioral theories to improve medication adherence among patients with hypertension. Nili, M., Mohamed, R., Kelly, KM.[2021]

A systematic review of 9 randomized controlled trials involving 1159 participants found that app-based interventions significantly improve medication adherence, with users being over twice as likely to report adherence compared to those receiving usual care or non-BCT apps.

Despite the positive impact on adherence, the study did not find specific behavior change techniques (BCTs) that were consistently associated with greater efficacy, indicating a need for further research to identify effective strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do mobile device apps designed to support medication adherence demonstrate efficacy? A systematic review of randomised controlled trials, with meta-analysis. Armitage, LC., Kassavou, A., Sutton, S.[2021]

A three-month study involving 126 veterans with coronary artery disease showed that using a pill bottle with daily alarms and feedback reports significantly improved statin medication adherence compared to a control group, with adherence rates of 89% and 86% for individual and partner feedback groups, respectively.

However, after the intervention ended, adherence rates dropped significantly for both feedback groups, indicating that while the intervention was effective in the short term, it did not create lasting habits, as adherence rates were similar to the control group at six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Partner Feedback Reports to Improve Statin Medication Adherence: A Randomized Control Trial. Reddy, A., Huseman, TL., Canamucio, A., et al.[2022]

A randomized controlled trial involving 46,581 participants showed that behavioral science-based reminders significantly improved medication adherence, with an increase of 0.95 percentage points during the mailing period.

The most effective reminders were those that prompted participants to predict their adherence and commit to a specific level of adherence, resulting in a cost-effective increase of 0.7 pills per dollar spent over the 181-day study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of interactive reminders on medication adherence: A randomized trial. Dai, H., Mao, D., Volpp, KG., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10209662

1R01HL153750-01A1 - NIH RePORTER The overall objective for this R01 application is to determine the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication ...

2. tulane.trialstoday.org tulane.trialstoday.org/trial/NCT05183763

Medication Adherence Program A health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life.

3. clinicaltrial.be clinicaltrial.be/en/details/34698?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Medication Adherence Program Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence ...

4. ctv.veeva.com ctv.veeva.com/study/medication-adherence-program

Medication Adherence Program (MAP) - ClinicalTrials.Veeva Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence ...

5. tulane.trialstoday.org tulane.trialstoday.org/?page=eJyLViooSi3LzC8tVtJR8nMOMTA1tjAyMrBQ0tG1hAEdYz1DQwsLAxNTHUNzU0NjIwsDMNBRyksuMTAzMQdqMFOKBQDSzRHE

Tulane Research - Clinical Translational Unit Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a ...

6. reporter.nih.gov reporter.nih.gov/search/19bNeL8UM0S5NxbyDecVfg/project-details/10847397

Project Details - NIH RePORTER The overall objective for this R01 application is to determine the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication ...

7. withpower.com withpower.com/trial/phase-hypertension-2022-0eeb8

Health Coaching + Medication Reminders for High Blood ... This trial tests a health coaching program called STAR-MAP, which helps people aged 50+ with uncontrolled high blood pressure take their medication regularly.