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Behavioural Intervention

Behavioral Interventions for High Blood Pressure (ENGAGE-HTN Trial)

N/A
Waitlist Available
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Diagnosis of hypertension
Must not have
Do not speak English or Spanish
Pregnancy, dementia, or terminal conditions as per ICD-10 codes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial aims to test a medication adherence intervention delivered by clinical pharmacists in a primary care setting for patients with uncontrolled hypertension. The study will focus on testing different recruitment methods and the impact of these

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on patient recruitment strategies rather than medications or medical procedures, there are no direct side effects associated with the interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with high blood pressure.
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I am taking medication for high blood pressure.
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I haven't taken my blood pressure medication as prescribed in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English or Spanish.
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I am not pregnant, do not have dementia, and do not have a terminal condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who completed an adherence counseling session
Secondary study objectives
Diastolic blood pressure
Number of days that participants were adherent to blood pressure medication
Number of days that participants were adherent to statin medication
+2 more

Trial Design

8Treatment groups
Active Control
Group I: Postcard/control letter/4 callsActive Control3 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 callsActive Control3 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 callsActive Control2 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 callsActive Control3 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 callsActive Control2 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 callsActive Control2 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 callsActive Control2 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 callsActive Control3 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

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,471 Previous Clinical Trials
2,535,766 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,419 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,653 Previous Clinical Trials
11,490,451 Total Patients Enrolled
~350 spots leftby Jan 2025
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