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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
NT-proB-type Natriuretic Peptide (NT-proBNP)
Systolic blood pressure (BP)
Secondary outcome measures
Geospatial outreach
Pharmaceutical Preparations
Other outcome measures
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
300 Previous Clinical Trials
2,099,635 Total Patients Enrolled
9 Trials studying Heart Failure
1,041 Patients Enrolled for Heart Failure
Wayne State UniversityOTHER
307 Previous Clinical Trials
108,109 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical investigation still open?

"This medical trial, which was originally published on January 18th 2023 and recently revised February 8th of the same year, is currently recruiting suitable participants."

Answered by AI

How many individuals are being enrolled in this testing protocol?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this investigation, which was published on 18th January 2023, is actively recruiting participants. A total of 364 volunteers are needed from a single medical facility."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Wayne State University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Project 2: ACHIEVE- HF
David Lanfear 2023. "Project 2: ACHIEVE- HF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05330221.
All > Heart Failure
~43 spots leftby Jun 2024
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