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

NCT07385209 | Not Yet Recruiting

• 2 other identifiers: 2025L39372364022
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease

Keywords

home care; mobile health; postoperative rehabilitation; caregiver support

Outcome Measures

Primary Outcomes (4)

• Family Health Score

  Score on the Chinese version of the Family Health Scale (FHS).

  Change from Baseline at 6 months post-discharge

• Family Stress Score

  Score on the Congenital Heart Disease Family Stressor Scale.

  Change from Baseline at 6 months post-discharge

• Child's Quality of Life Score

  Score on the Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cardiac Module.

  Change from Baseline at 6 months post-discharge

• Caregiver's Quality of Life Score

  Score on the 36-Item Short Form Health Survey (SF-36).

  Change from Baseline at 6 months post-discharge

Secondary Outcomes (2)

• Body Weight

  Measured at 1, 3, and 6 months post-discharge

• Left Ventricular Ejection Fraction

  Measured at 6 months post-discharge

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants receiving the WeChat mini-program intervention.

Other: Routine Care with Telephone Follow-up

Control Group

ACTIVE COMPARATOR

Participants receiving routine care with telephone follow-up.

Device: Home Care WeChat Mini-Program

Interventions

Home Care WeChat Mini-Program DEVICE

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

Control Group

Routine Care with Telephone Follow-up OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 0 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• ruijie YangLan: lead

Study Sites (1)

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Fang Ma,, professor of nursing

  First Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

• Fang Ma, professor of nursing

  First Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruijie YangLan, Graduate Student

CONTACT

+86-18887278258; 1052076436@qq.com

Fang Ma,, Director Nurse

CONTACT

+86-15925189957; rebeccamalei@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the behavioral intervention (use of a specific WeChat mini-program), it was not feasible to blind the participants, care providers, or investigators. However, the outcomes assessors and data analysts were blinded to group allocation throughout the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)