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

NCT07055334 | Not Yet Recruiting

• 1 other identifier: LSLL2024-801
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Defects, Congenital; Rehabilitation; Preschool Child; Qualitative Research; Caregivers; Medical Staff, Hospital

Keywords

congenital heart disease; home-based cardiac rehabilitation; Primary caregiver; qualitative research; preschool child

Outcome Measures

Primary Outcomes (1)

• Number of Core Components Finalized in the Home Rehabilitation Scheme Based on Expert Consensus

  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.

  12 months (from initiation to completion of scheme development)

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes three groups. For children with congenital heart disease after surgery, inclusion criteria are age 3 to 7, one-time corrective open-heart surgery in the research unit, and ability to communicate in Chinese. Exclusions are arrhythmia after surgery, other diseases unsuitable for exercise, heart function class IV, and perioperative disorders. For caregivers, must be main caregiver, volunteer, spend most time caring, and communicate in Chinese. Exclusions are those who give up treatment, are paid caregivers, have cognitive impairment or mental illness, cannot express feelings, have contradictions with child, or cannot use electronic devices. For medical professionals, must hold license and have at least 5 years of related practice. Exclusions are non-frontline staff or those absent in recent year.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wei XIA, PhD: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510080, 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

• Xia Wei, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia Wei, PhD

CONTACT

+8618823359471; xiaw23@mail.sysu.edu.cn

Luo Cong, Master

CONTACT

+8619731525206; luoc3@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 8, 2025
• Study Start: July 10, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)