Health Advocate for Children After Liver Transplant

Conditions

• Pediatric Liver Transplanted Recipients

Eligibility Criteria

Sex

ALL

Age

0 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Health advocate — BEHAVIORAL
  The health advocate is a trained individual who is not a part of the medical team. They work directly with the caregivers of patients who have received a liver transplantation to assist them with navigating the healthcare system, find resources, and relay any concerns to their medical team. They work with an assigned family for 90-days and tailor their intervention to meet the families social needs.
• Enhanced Control — BEHAVIORAL
  Caregivers in the control arm will receive enhanced standard of care: they will be given a handout with a list of resources specific to their hardship and their home ZIP code. They will receive a follow-up call at 45 days with a reminder of the suggested resources.

Study Details

The HEAL-Tx is a 90-day intervention, in which a Health Advocate works with eligible families to identify and apply for community-based resources, alert healthcare providers to challenges the family is encountering, and guide health system navigation (e.g., coordinating appointments). Families in the control arm will receive a printed handout that provides contact information for local community-based resources. Families in the treatment arm will receive HEAL-Tx.

Key Dates

First listed

Dec 12, 2025

Start date

May 5, 2026

Status verified

Aug 2026

Primary completion

Aug 1, 2030

Completion

Aug 1, 2030

Study Design

Enrollment

108 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Health Advocate Intervention
  The caregiver will receive 90-days of tailored health advocate intervention
• Active Comparator: Enhanced Control
  The caregiver will receive a printed sheet of resources once and a follow-up call at the 45-day timepoint with a reminder of the suggested resources.

Primary Outcome Measure

Time-to-TCMR between 90 days and 2 years post-transplant using Kaplan-Meir plots. [ Time Frame: Through study completion, an average of 1 year up to 2 years. ]

Central Contacts

• Bethany Reyna, BA, CCRP
  415-476-7748
  [email protected]
• Andrea Huerta
  [email protected]

Locations (2)

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