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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
311 Previous Clinical Trials
2,176,032 Total Patients Enrolled
9 Trials studying Heart Failure
1,041 Patients Enrolled for Heart Failure
Wayne State UniversityOTHER
314 Previous Clinical Trials
110,533 Total Patients Enrolled
10 Trials studying Heart Failure
4,924 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I use insulin or more than one diabetes medication regularly.I have been diagnosed with heart failure before.I have high blood pressure or controlled hypertension with other heart risk factors.This criterion is incomplete. Can you please provide more details or context?
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care Group
- Group 2: Intervention Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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