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Starting soon Not applicable

Design and Application of a Home Care WeChat Mini-Program for Children After Congenital Heart Disease Surgery

NCT07385209 · tracked via the Priya Life Science China tracker
Sponsor
ruijie YangLan
Phase
Not applicable
Started
2026-03-30
Last updated
2026-02-04

Condition(s) studied

Congenital Heart Disease

Investigational drug(s) / intervention(s)

Home Care WeChat Mini-ProgramRoutine Care with Telephone Follow-up

Home Care WeChat Mini-Program: A family-centered WeChat mini-program providing health education, peer support, and remote monitoring for post-operative care.

Routine Care with Telephone Follow-up: Participants in this group will receive standard post-discharge care as per hospital protocol, which includes initial discharge education and scheduled telephone follow-ups by hospital staff at 1, 3, and 6 months post-discharge to assess the child's status and answer questions.

Study summary

This is a single-blind, randomized controlled trial aimed at evaluating the effectiveness of a family-centered, WeChat-based home care mini-program for children after congenital heart disease (CHD) surgery. Given the chronic nature of post-operative CHD management and the significant stress placed on families, this study shifts from a deficit-based to a strengths-based perspective, guided by the Double ABC-X model. Children (≤12 years old) who have undergone CHD surgery and their primary caregivers will be recruited. Participants will be randomly assigned to either the intervention group, which uses the mini-program for health education, peer support, and physiological monitoring, or the control group, which receives routine telephone follow-up. The primary outcomes are family health (measured by the Family Health Scale), family stress, and the quality of life for both the child and caregivers. Secondary outcomes include physiological parameters such as the 6-minute walk test distance. The study aims to provide evidence for a scalable digital health intervention to support long-term family adaptation and child recovery.

Eligibility

Sex
ALL
Min age
0 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria: * \- The child is ≤12 years old. * The child has been diagnosed with congenital heart disease (CHD) and is scheduled for or has undergone corrective surgery. * The child is in a stable medical condition (non-acute phase). * At least one primary caregiver (parent or sibling \>12 years old) of the child agrees to participate. * The caregiver provides written informed consent to participate in the study. Exclusion Criteria: * \- The child has severe developmental defects. * The child has other major diseases that significantly affect quality of life. * The caregiver has visual, hearing, or cognitive impairments that hinder communication. * The caregiver has a diagnosed psychiatric disorder. * The caregiver is unconscious or otherwise unable to provide consent.

Primary outcome measure(s)

  • Family Health Score — Change from Baseline at 6 months post-discharge
    Score on the Chinese version of the Family Health Scale (FHS).
  • Family Stress Score — Change from Baseline at 6 months post-discharge
    Score on the Congenital Heart Disease Family Stressor Scale.
  • Child's Quality of Life Score — Change from Baseline at 6 months post-discharge
    Score on the Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cardiac Module.
  • Caregiver's Quality of Life Score — Change from Baseline at 6 months post-discharge
    Score on the 36-Item Short Form Health Survey (SF-36).

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital of Kunming Medical University Kunming Yunnan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07385209 on ClinicalTrials.gov ↗ ← All trials in China