Your session is about to expire
← Back to Search
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 Centers not fully able to participate or no longer active are excluded.Check my eligibility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
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 moreSOCIAL 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
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
993 Previous Clinical Trials
1,093,820 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,816,773 Total Patients Enrolled
1 Trials studying Decision Making
7,818 Patients Enrolled for Decision Making
Khadijah Breathett, MD, MSPrincipal InvestigatorIndiana University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My treatment center is not equipped for the study's required training and evaluations.My center sees many patients from diverse backgrounds and women for advanced heart failure treatments.You are currently on the waiting list for a heart transplant or have a ventricular assist device.People who work at the hospitals involved in the study, such as doctors, nurses, and pharmacists.
Research Study Groups:
This trial has the following groups:- Group 1: Sites Randomized to SOCIAL HF
- Group 2: Control Sites
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.
Share this study with friends
Copy Link
Messenger