Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07055334

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

    The home rehabilitation scheme will be developed using a two-round Delphi method with a multidisciplinary expert panel. Each proposed module will be rated by experts for its relevance, feasibility, and clarity. Components reaching ≥75% agreement (rated as "agree" or "strongly agree") will be considered finalized. The outcome will be reported as the number and percentage of components finalized out of all proposed components.

Study contacts

Contact information is provided by the study sponsor or research team.

Luo Cong, Master

CONTACT

[email protected]

+8619731525206

Xia Wei, PhD

CONTACT

[email protected]

+8618823359471

Sponsors and collaborators

Lead sponsor

Wei XIA, PhD

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.