Health Coaching + Medication Reminders for High Blood Pressure
(MAP Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Overseen byMarie A Krousel-Wood, MD, MSPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Tulane University
Must be taking: Antihypertensives
Disqualifiers: Cognitive impairment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the treatment Health Coaching + Medication Reminders for High Blood Pressure?
Research shows that health coaching can help people with high blood pressure improve their diet, exercise, and medication habits. Additionally, reminders have been found to slightly increase how well people stick to their medication schedules. Using behavior change techniques can also help people better follow their medication plans.
12345Is the Health Coaching + Medication Reminders treatment safe for humans?
The research on medication reminders, including text messages and app-based interventions, generally shows that these methods are safe for humans, as they primarily involve non-invasive techniques like sending reminders to take medications.
36789How is the STAR-MAP health coaching treatment for high blood pressure different from other treatments?
The STAR-MAP health coaching treatment is unique because it combines personalized health coaching with medication reminders to improve adherence to blood pressure medication, which can lead to better blood pressure control. This approach focuses on behavioral changes and patient engagement, rather than just medication alone, making it different from standard drug treatments.
12101112Eligibility Criteria
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
+9 more
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.
Trial Timeline
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
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tulane Doctors Dermatology & Multispecialty ClinicCovington, LA
Tulane University Clinical and Translational UnitNew Orleans, LA
LSU Health Sciences Shreveport Clinical Trials OfficeShreveport, LA
Tulane Doctors Heart & Vascular and Primary Care ClinicMetairie, LA
More Trial Locations
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Who Is Running the Clinical Trial?
Tulane UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
Ohio State UniversityCollaborator
Minds at WorkCollaborator
References
A pharmacist health coaching trial evaluating behavioural changes in participants with poorly controlled hypertension. [2022]To investigate whether pharmacist health coaching improves progression through the stages of change (SOC) for three modifiable health behaviours; diet, exercise, and medication management in participants with poorly controlled hypertension.
Impact of Physician Referral to Health Coaching on Patient Engagement and Health Risks: An Observational Study of UPMC's Prescription for Wellness. [2021]Evaluate impact of physician referral to health coaching on patient engagement and health risk reduction.
The effect of interactive reminders on medication adherence: A randomized trial. [2022]Expanding on evidence that interventions to improve health are more effective when informed by behavioral science, we explore whether reminders designed to harness behavioral science principles can improve medication adherence. We conducted a randomized controlled trial with 46,581 U.S. participants with commercial or Medicare Advantage insurance from Humana. Participants were randomly assigned to one of four experimental conditions. Participants in the usual care condition only received standard mailings that the insurer usually sends. In addition to the standard mailings, participants in the other three conditions also received (1) mailings that reminded them to take a target medication (basic reminder condition), (2) reminders that prompted them to predict their medication adherence in the next 30days (prediction condition), or (3) reminders that prompted them to commit to a self-determined level of adherence for the next 30days (commitment condition). We sent these mailings once a month for three months from November, 2014 through January, 2015, and tracked prescription refills. We find that, during the mailing period, reminders increased adherence by 0.95 percentage points (p
A systematic review of interventions using health behavioral theories to improve medication adherence among patients with hypertension. [2021]Medication adherence is a major problem in the treatment of hypertension. Approximately half of the patients who use antihypertensive medications are not adherent. Several interventions have endeavored to improve medication adherence among patients with hypertension, and some have used health behavioral models/theories. However, the quality and effectiveness of using health behavioral models/theories in improving medication adherence among patients with hypertension remain unknown. The main aim of this systematic review was to describe study characteristics and types of health behavioral models/theories used in interventions for improving medication adherence among adults with hypertension. PubMed, Scopus, Ovid MEDLINE, CINAHL, and PsycINFO databases were searched for randomized clinical trial interventions using any health behavioral models/theories published in English from 1979 to 2019. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, two independent reviewers searched, screened abstracts and articles, extracted data, and assessed the risk of bias and the use of the model/theory using the Theory Coding Scheme. A total of 11 articles were included in this systematic review. Two studies reported significant improvement in medication adherence. The Self-Regulation Model and Social Cognitive Theory were the most common types of models/theories. Nine studies used a single model/theory, and four studies measured the constructs of a model/theory. Risk of bias was good (n = 4) and fair (n = 5) in interventions. Using health behavioral models/theories may be an efficient way for health care professionals to improve adherence to medications among patients with hypertension. More interventions with rigorous designs are needed that appropriately utilize health behavioral models/theories for improving medication adherence among adults with hypertension.
Behavior-changing methods for improving adherence to medication. [2019]Long-term adherence to antihypertensive drug therapy is poor, and new strategies to predict and improve adherence to prescribed drug regimens are needed. The literature on behavior change is reviewed, and a new perspective on medication adherence is presented. Successfully adopting and continuing with a long-term medication regimen requires behavior change, and behavior change principles can be used to accelerate the adoption of adherence to medication- taking behavior. The efficacy of behavior-changing interventions, which are tailored to each patient's stage of change, has been demonstrated in several health behavior areas. Rewards, monitoring devices, and reminder techniques are most useful for individuals in later stages of behavior change, but individuals in earlier stages need consciousness-raising interventions that focus upon awareness of the benefits of therapy. Recent research has yielded reliable ways to measure the stage of change for medication adherence, providing the foundation for the application of behavior- changing principles to the pharmacologic management of hypertension.
Behavioral Nudges as Patient Decision Support for Medication Adherence: The ENCOURAGE Randomized Controlled Trial. [2022]Medication adherence is generally low and challenging to address because patient actions control healthcare delivery outside of medical environments. Behavioral nudging changes clinician behavior, but nudging patient decision-making requires further testing. This trial evaluated whether behavioral nudges can increase statin adherence, measured as the proportion of days covered (PDC).
Do mobile device apps designed to support medication adherence demonstrate efficacy? A systematic review of randomised controlled trials, with meta-analysis. [2021]To estimate the efficacy of app-based interventions designed to support medication adherence and investigate which behaviour change techniques (BCTs) used by the apps are associated with efficacy.
Patient and Partner Feedback Reports to Improve Statin Medication Adherence: A Randomized Control Trial. [2022]Simple nudges such as reminders and feedback reports to either a patient or a partner may facilitate improved medication adherence.
The effect of text message reminders on medication adherence among patients with coronary heart disease: A systematic review and meta-analysis. [2022]To determine the effectiveness of text message reminders (TMR) on medication adherence (MA) and to investigate the effects of TMR on clinical outcomes.
The effect of a practice-based multicomponent intervention that includes health coaching on medication adherence and blood pressure control in rural primary care. [2021]Low adherence to anti-hypertensive medications contributes to worse outcomes. The authors conducted a secondary data analysis to examine the effects of a health-coaching intervention on medication adherence and blood pressure (BP), and to explore whether changes in medication adherence over time were associated with changes in BP longitudinally in 477 patients with hypertension. Data regarding medication adherence and BP were collected at baseline, 6, 12, 18, and 24 months. The intervention resulted in increases in medication adherence (5.75→5.94, P = .04) and decreases in diastolic BP (81.6→76.1 mm Hg, P
Direct observation and patient recall of health behavior advice. [2023]Patient recall of health behavior change discussions with physicians is an important intermediate outcome to adherence with recommendations and subsequent behavior change. This study reports patient recall of health behavior discussions during outpatient visits and tests patient and visit characteristics associated with recall.
Approach to antihypertensive adherence: a feasibility study on the use of student health coaches for uninsured hypertensive adults. [2021]Despite pharmacologic advances, medication non-adherence continues to challenge primary care providers in blood pressure (BP) management. Medical, nursing and pharmacy students (n=11) were recruited and trained as health coaches for uninsured, hypertensive patients (n=25) of a free clinic in an uncontrolled open trial. Pre-post analysis was conducted on BP, medication adherence, frequency of home BP monitoring, and health behavior (eg, diet, exercise). Patient satisfaction and feasibility of a student coach model was qualitatively evaluated. In the 12 patients who completed the intervention, an increase in medication adherence as measured by the Brief Medication Questionnaire was observed (P