Behavioral Interventions for High Blood Pressure

(ENGAGE-HTN Trial)

Overseen By Ian Kronish, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: Blood pressure medications

Disqualifiers: Pregnancy, Dementia, Terminal conditions

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to identify the best methods to encourage adherence to high blood pressure medication. It tests various approaches, such as sending postcards or making phone calls, to determine what increases the likelihood of patients consulting a pharmacist for advice. Suitable participants have poorly controlled high blood pressure and often forget or skip their medication. Participants receive personalized support from a clinical pharmacist to enhance their medication routine through adherence interventions based on behavioral science.

As an unphased trial, this study provides a unique opportunity for patients to receive personalized support and contribute to research that could enhance medication adherence strategies for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study focuses on improving adherence to blood pressure medications, it seems likely that you will continue taking them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that behavioral treatments can help people with high blood pressure manage their health more effectively. These treatments focus on helping individuals remember to take their medication on time, leading to better blood pressure control and a lower risk of heart problems.

Studies have found these treatments to be generally safe. They work by changing how people think about and manage their medication routines. No reports of harmful side effects exist because these treatments do not involve new drugs. Instead, they use reminders like phone calls and letters to assist patients in taking their medicine.

Previous research on similar treatments has not shown any major safety concerns, suggesting that the treatment is well-tolerated by most people. Thus, joining a trial like this is likely safe and could help manage high blood pressure more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the power of behavioral science to enhance patient adherence to hypertension treatments. Unlike traditional approaches that often rely solely on medication, this trial uses tailored communication methods, like prospect theory-informed recruitment letters and priming postcards, to engage patients. By focusing on improving adherence through personalized communication strategies, the trial aims to boost the effectiveness of existing treatments, potentially leading to better blood pressure control and overall health outcomes.

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

This trial will evaluate various behavioral interventions to improve medication adherence for high blood pressure management. Research has shown that focusing on changing habits can help people take their medication on time, which is crucial for managing high blood pressure and lowering the risk of heart issues. A review of studies found that assisting people in following their medication schedule can significantly impact their health. For those with high blood pressure, even small improvements in medication adherence can greatly aid in controlling it. Previous trials demonstrated that regular medication intake leads to better health outcomes, highlighting the importance of these habit-changing strategies. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English or Spanish speaking adults over 18 with uncontrolled high blood pressure and poor medication adherence, identified through their primary care records. Their doctors can choose to exclude them from the trial if necessary.

Inclusion Criteria

Office BP >=140/90 mmHg at most recent office visit

I haven't taken my blood pressure medication as prescribed in the last 6 months.

Receive care at a Columbia-affiliated primary care clinic in the Ambulatory Care Network

Exclusion Criteria

I am not pregnant, do not have dementia, and do not have a terminal condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment

Testing of behaviorally-informed recruitment approaches in a primary care setting

4 months

Multiple outreach attempts (up to 4 calls)

Adherence Counseling

Participants receive a brief evidence-based medication adherence counseling session

12 weeks

1 visit (telephone or video)

Follow-up

Participants are monitored for medication adherence and clinical outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Engaging Patients in Adherence Interventions Using Behavioral Science

Trial Overview The study tests different ways to recruit patients using behavioral science techniques for a pharmacist-led medication adherence program. It involves up to four phone calls and various recruitment letters, comparing which combination is most effective.

How Is the Trial Designed?

Group I: Postcard/control letter/4 calls Active Control 3 Interventions

Mailed a priming postcard, followed by a usual care control recruitment letter, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group II: Postcard/behavioral letter/4 calls Active Control 3 Interventions

Mailed a priming postcard, followed by a prospect theory-informed recruitment letter, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group III: No postcare/control letter/2 calls Active Control 2 Interventions

Mailed a usual care control recruitment letter that is not preceded by a priming postcard, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group IV: Postcard/behavioral letter/2 calls Active Control 3 Interventions

Mailed a priming postcard, followed by a prospect theory-informed recruitment letter, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group V: No postcard/behavioral letter/4 calls Active Control 2 Interventions

Mailed a prospect-theory informed recruitment letter that is not preceded by a priming postcard, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group VI: No postcard/control letter/4 calls Active Control 2 Interventions

Mailed a usual care control recruitment letter that is not preceded by a priming postcard, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group VII: No postcard/behavioral letter/2 calls Active Control 2 Interventions

Mailed a prospect theory-informed recruitment letter that is not preceded by a priming postcard, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group VIII: Postcard/control letter/2 calls Active Control 3 Interventions

Mailed a priming postcard, followed by a usual care control recruitment letter, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-hypertension-7-2024-20618

Behavioral Interventions for High Blood Pressure ... By addressing behavioral aspects, these interventions can lead to better blood pressure management and reduce the risk of heart-related issues.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5662945/

Interventions to Improve Medication Adherence in ... This systematic review applied meta-analytic procedures to synthesize medication adherence interventions that focus on adults with hypertension.

3. ahajournals.org ahajournals.org/doi/10.1161/hyp.0000000000000203

Medication Adherence and Blood Pressure Control Numerous trials have evaluated the impact of SMBP on medication adherence and found small but significant improvements in medication adherence ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1564791/full

Impact of blood pressure and medication adherence on ... Conclusion: Higher SBP and poor medication adherence were independently associated with worse clinical outcomes in patients with hypertension.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2667276624001070

Behavioral factors associated with medication adherence ... Theoretical exploration of the behavioral factors associated with adherence to medication in hypertensive patients has been limited in previous studies.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11381960/

Impact of Interventions on Medication Adherence in ... Several interventions have been developed to help improve medication adherence in patients with coexisting diabetes and hypertension.

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.039045

Low Adherence to High Blood Pressure Treatments Among 379 503 individuals with hypertension, 54.4% adhered to antihypertensives. Treatment adherence was associated with significantly lower per ...

8. mhealth.jmir.org mhealth.jmir.org/2024/1/e53006/

Development of a Health Behavioral Digital Intervention for ... The primary outcomes included BP and adherence indicators. Data analysis was performed using SPSS, with independent sample t tests, chi-square ...