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Not yet recruiting NCT07055334

Development and Improvement of Home Rehabilitation Scheme for Preschool Children With Congenital Heart Disease After Operation

Observational Heart Defects, Congenital Rehabilitation Preschool Child Qualitative Research

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Defects, Congenital, Rehabilitation, Preschool Child, Qualitative Research. Basic parameters: from 3 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This part of the study focuses on understanding the home rehabilitation situation for preschool children with congenital heart disease after operation. Qualitative research interviews with caregivers and medical staff (including doctors, nurses, rehabilitation therapists, nutritionists, and psychologists) are conducted to explore the benefits, obstacles, and professional guidance needs of home rehabilitation. The aim is to summarize the best evidence for home rehabilitation through evidence-based nursing and qualitative research, in order to develop a more comprehensive and suitable home rehabilitation scheme for these children.

Primary outcome measures

  • Number of Core Components Finalized in the Home Rehabilitation Scheme Based on Expert Consensus [Time frame: 12 months (from initiation to completion of scheme development)]

Eligibility criteria

Children With Congenital Heart Disease After Surgery

Inclusion criteria

  • Age 3 to 7 years
  • Clinical diagnosis of congenital heart disease
  • Underwent a single open-heart surgical correction under direct vision at the study site
  • Ability to communicate in Chinese

Exclusion criteria

  • Postoperative arrhythmia
  • Comorbid neurological, respiratory, or other systemic diseases
  • Deemed unsuitable for exercise by a physician
  • Cardiac function classified as NYHA Class IV
  • Intellectual, language, or motor impairments resulting from perioperative complications or other causes

Caregivers of Children With Congenital Heart Disease After Surgery

Inclusion criteria

  • Primary caregiver who voluntarily provides care
  • Caregiver who spends the most time with the child
  • Ability to communicate in Chinese

Exclusion criteria

  • Caregivers of children who voluntarily discontinued treatment before completion
  • Paid or professional caregivers
  • Diagnosed cognitive impairment or mental illness
  • Inability to communicate effectively through spoken language
  • Presence of serious conflict or instability in the caregiver-child relationship
  • Inability to independently operate or use smart electronic devices and the internet

Medical Professionals Involved in Congenital Heart Disease Care

Inclusion criteria

  • Licensed healthcare professionals, including physicians, nurses, dietitians, physical therapists, or psychological counselors
  • At least 5 years of professional experience in congenital heart disease care, rehabilitation, or education

Exclusion criteria

  • Not currently engaged in frontline clinical work
  • Not engaged in clinical work within the past year due to leave, study, or reassignment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

China · 1 center
  • Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07055334 · LSLL2024-801

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗