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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rehabilitation; Heart Defects, Congenital; Caregivers; Qualitative Research; Preschool Child; Medical Staff, Hospital

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Xia Wei, PhD; Phone Number: +8618823359471; Email: xiaw23@mail.sysu.edu.cn
• Study Contact Backup: Name: Luo Cong, Master; Phone Number: +8619731525206; Email: luoc3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Wei XIA, PhD
• Investigators: Principal Investigator: Xia Wei, PhD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 5, 2025
• First Submitted That Met QC Criteria: June 27, 2025
• First Posted (Estimated): July 8, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: congenital heart disease; qualitative research; preschool child; Primary caregiver; home-based cardiac rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: LSLL2024-801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No