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Behavioral Intervention

Community Health Worker Program for Heart Failure

N/A
Recruiting
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

This trialaims to reduce health disparities & Black-White lifespan inequality with CHWs delivering an evidence-based program to mitigate risk factors for heart failure, hypertension & coronary heart disease.

Who is the study for?
This trial is for self-identified Black/African American adults living in the Detroit area with high blood pressure or additional heart failure risk factors. It's not for those with uncontrolled diabetes, resistant hypertension, current pregnancy plans, previous heart failure diagnosis, multiple anti-diabetic drugs use, or extremely high blood pressure.
What is being tested?
The ACHIEVE-HF project tests an intervention program called PAL2 delivered by Community Health Workers to reduce health disparities in managing heart failure and high blood pressure among African Americans in Detroit and Cleveland.
What are the potential side effects?
Since this trial involves a non-drug intervention (PAL2), traditional medication side effects are not applicable. However, participants may experience stress or discomfort from lifestyle changes or monitoring required by the program.

Timeline

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
NT-proB-type Natriuretic Peptide (NT-proBNP)
Systolic blood pressure (BP)
Secondary study objectives
Geospatial outreach
Pharmaceutical Preparations
Other study objectives
BP Control (<130/80)
Change in creatinine
Body Weight Changes
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment2 Interventions
PAL2 Intervention Drug Therapy
Group II: Usual Care GroupActive Control1 Intervention
Participants that are randomized into usual care will be assisted with arrangement of follow-up, either with existing primary care provider (PCP) or a Wayne Health provider. All subsequent medical treatment will be at the discretion of the PCP.

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
309 Previous Clinical Trials
2,167,978 Total Patients Enrolled
9 Trials studying Heart Failure
1,041 Patients Enrolled for Heart Failure
Wayne State UniversityOTHER
312 Previous Clinical Trials
108,687 Total Patients Enrolled
10 Trials studying Heart Failure
4,924 Patients Enrolled for Heart Failure

Media Library

PAL2 (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05330221 — N/A
Heart Failure Research Study Groups: Usual Care Group, Intervention Group
Heart Failure Clinical Trial 2023: PAL2 Highlights & Side Effects. Trial Name: NCT05330221 — N/A
PAL2 (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05330221 — N/A
~186 spots leftby Jun 2026
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