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Allocation Method for Advanced Heart Failure (SOCIAL HF Trial)

N/A

Waitlist Available

Led By Khadijah Breathett, MD, MS

Research Sponsored by Indiana University

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 up to 3 years

Awards & highlights

SOCIAL HF Trial Summary

This trial will test a new way of allocating advanced heart failure therapies that may help reduce bias and improve group dynamics. The results could help inform national guidelines for such treatments.

Who is the study for?

This trial is for heart transplant and ventricular assist device centers that see at least 50 minority patients and 50 women over two years. It includes professionals like coordinators, physicians, pharmacists, nurses, social workers involved in advanced therapy decisions. Centers not fully able to participate or no longer active are excluded.Check my eligibility

What is being tested?

The SOCIAL HF trial tests a strategy aimed at equitable allocation of heart failure therapies by reducing bias and using objective criteria over subjective judgment. The study's design may influence national guidelines on how advanced therapies for chronic diseases are allocated.See study design

What are the potential side effects?

Since this trial focuses on decision-making processes rather than direct patient interventions, it does not involve medical side effects. However, the outcomes could affect how treatments like transplants are distributed among patients.

SOCIAL HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in SOCIAL HF fidelity from time of training completion (month 2) to time study target has been reached (up to 2 years) and 6 months after reaching study target (up to 2.5 years)

Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies.

Secondary outcome measures

Adoption of SOCIAL HF

Change from baseline knowledge, attitudes, and self-reported behavior change among clinicians at 2 months and time at which study target has been reached (up to 2 years)

Change from baseline sum group function scores at 2 months and time at which study target has been reached (up to 2 years)

+3 more

SOCIAL HF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sites Randomized to SOCIAL HFExperimental Treatment1 Intervention

SOCIAL HF is composed of evidence-based bias reduction training, employment of objective measures of social support, and changes to facilitate group dynamics.

Group II: Control SitesActive Control1 Intervention

No Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,698 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,834 Previous Clinical Trials

47,309,172 Total Patients Enrolled

1 Trials studying Decision Making

7,818 Patients Enrolled for Decision Making

Khadijah Breathett, MD, MSPrincipal InvestigatorIndiana University

Media Library

SOCIAL HF Clinical Trial Eligibility Overview. Trial Name: NCT05390411 — N/A

Decision Making Research Study Groups: Sites Randomized to SOCIAL HF, Control Sites

Decision Making Clinical Trial 2023: SOCIAL HF Highlights & Side Effects. Trial Name: NCT05390411 — N/A

SOCIAL HF 2023 Treatment Timeline for Medical Study. Trial Name: NCT05390411 — N/A

Frequently Asked Questions

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

What is the ultimate goal of this clinical experiment?

"The primary aim of this investigation, which will be tracked for up to 3 years, is to assess the changes in SOCIAL HF fidelity from post-training (month 2) through study target completion (up to two years). Secondary objectives include an analysis of discussion themes during allocation meetings based on race/ethnicity and gender as well as alteration in baseline knowledge, attitudes, and self-reported behavior change among clinicians at 2 months. Moreover, a measure of reach regarding SOCIAL HF will also be taken using the proportion of patients evaluated with any components thereof."

Answered by AI

Are there any opportunities for prospective participants to join this trial?

"As indicated by information on clinicaltrials.gov this trial is no longer accepting candidates, having been initially posted on January 1st 2023 and last edited September 6th 2022. Nevertheless, there are currently 740 other medical trials actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial

Khadijah Breathett, MD, MS, FACC, FAHA, FHFSA 2023. "Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05390411.