Health Advocate for Children After Liver Transplant

(HEAL-Tx:RCT Trial)

AH
BR
Overseen ByBethany Reyna, BA, CCRP
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist families of children who have recently undergone a liver transplant by providing support through a Health Advocate. The advocate will help families find and apply for community resources, coordinate healthcare appointments, and address any challenges they encounter. Families in the control group will receive a list of local resources and a follow-up call. The trial seeks families with children under 18 who have had a liver transplant within the last 90 days and are experiencing financial hardships. Participants should be able to communicate in English or Spanish and have access to a smartphone for virtual visits. As an unphased trial, this study offers families the opportunity to receive personalized support and resources during a challenging time.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on providing support and resources rather than changing medical treatments.

What prior data suggests that this Health Advocate intervention is safe for children after liver transplant?

Research has shown that the Health Advocate program is generally safe for families of children who have had a liver transplant. In this program, a Health Advocate assists families in finding and using local resources, communicates any concerns to healthcare providers, and guides them through the healthcare system.

No specific information exists on negative effects or side effects from having a Health Advocate. Since this program emphasizes support and resources rather than medications or medical treatments, it is expected to be safe. Previous studies on similar programs have shown that meeting social needs can improve health without causing harm.

Overall, the Health Advocate program aims to support families without adding health risks.12345

Why are researchers excited about this trial?

Researchers are excited about the Health Advocate intervention for children post-liver transplant because it offers a personalized support system for caregivers, something not typically found in standard care. Unlike traditional methods, which might include basic resource guides or sporadic check-ins, this intervention provides a tailored, 90-day program designed to address the specific needs of each caregiver. This individualized approach aims to improve the overall well-being and health outcomes for children by empowering their caregivers with the necessary tools and support.

What evidence suggests that the Health Advocate intervention is effective for children after liver transplant?

Research shows that children from challenging social backgrounds are more likely to experience problems after a liver transplant. Studies have found that improving social conditions can enhance health outcomes for these children. This trial tests the Health Advocate program as one of the interventions. The program helps families access local resources, reducing stress and improving care organization. Previous efforts to increase social support have led to better transplant outcomes, such as higher survival rates. Early evidence suggests that a Health Advocate can assist families in managing healthcare and improve children's recovery after a liver transplant.12678

Who Is on the Research Team?

SW

Sharad Wadhwani, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for families with children who have received a liver transplant. It's designed to help them navigate the healthcare system and access community resources effectively.

Inclusion Criteria

I am younger than 18 years old and need a liver transplant.
I had a liver transplant within the last 3 months.
Family endorses material economic hardship on the 10-questions Accountable Healthcare Communities screening tool
See 4 more

Exclusion Criteria

I have severe difficulty with thinking or memory.
I am 18 years old or older.
I am willing and able to give consent to participate.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

During transplant hospitalization

Baseline Assessment

Baseline interviews and assessments are conducted for both treatment and control arms

Baseline
1 visit (in-person or virtual)

Treatment

Participants in the treatment arm receive a 90-day Health Advocate intervention; control arm receives a printed handout and a follow-up call at 45 days

90 days
2 visits (in-person or virtual) for treatment arm, 1 follow-up call for control arm

Follow-up

Participants are monitored for outcomes and experiences with the intervention, including interviews at 90 days and data extraction at 1 and 2 years

Up to 2 years
Interviews at 90 days, data extraction at 1 and 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Health Advocate

Trial Overview

The study is testing a 90-day program where a Health Advocate assists families post-liver transplant versus just giving them a handout with resource contacts. The goal is to see if having personalized support makes a difference.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Health Advocate InterventionExperimental Treatment1 Intervention
Group II: Enhanced ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Health Advocate for Children After Liver Transplant

HEAL-Tx trial is a Type 1 hybrid effectiveness-implementation trial across 6 U.S. transplant centers (UCSF, Seattle Children's Hospital, ...

RePORT RePORTER - National Institutes of Health (NIH) |

Children facing social adversity, and those from socioeconomically deprived backgrounds have increased risk of graft failure and death following transplant.

Addressing social adversity to improve outcomes for ...

We lay out a strategy to develop and test interventions to address social adversity for children undergoing liver transplant.

Opportunities to Improve Liver Transplantation Outcomes ...

While post-transplant outcomes are excellent and 5-year pediatric patient survival exceeds 90%, much clinical and research effort in pediatric liver ...

Health Advocate for Children After Liver Transplant | MedPath

The HEAL-Tx is a 90-day intervention, in which a Health Advocate works with eligible families to identify and apply for community-based ...

NCT05700799 | HEalth Advocate for Liver Transplant - Pilot

The Health Advocate intervention will include helping pediatric liver transplant recipients and their families address unmet household social needs (e.g., food ...

Patient-centered research in pediatric transplant: Engaging ...

Pediatric liver transplant (LT) recipients navigate a lifelong journey that includes constant monitoring and challenges.

Health Advocate for Adolescent Liver Transplant Recipients

This trial tests a new support system to assist young people transitioning from pediatric to adult care after a liver transplant.