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FACE for Children With Rare Diseases

NCT04855734 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-05-04

Study results available
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Summary

Children with ultra-rare or complex rare diseases are routinely excluded from research studies because of their conditions, creating a health disparity. However, new statistical techniques make it possible to study small samples of heterogeneous populations. We propose to study the palliative care needs of family caregivers of children with ultra-rare diseases and to pilot test a palliative care needs assessment and advance care planning intervention to facilitate discussions about the future medical care choices families are likely to be asked to make for their child.

Conditions

Interventions

BEHAVIORAL

FAmily CEntered (FACE) pACP Intervention

The (approximately) weekly 3-session FACE-Rare intervention of approximately 45-60 minutes each is comprised of the CSNAT approach \[Sessions 1 \& 2\] and Respecting Choices \[Session 3\].

Sponsors & Collaborators

  • Respecting Choices

    collaborator UNKNOWN

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Maureen E Lyon, PhD · Children's National Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2023-12-31
Completion
2024-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04855734 on ClinicalTrials.gov