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Not yet recruitingNCT07055334Updated Jul 8, 2025

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

An observational study in Heart Defects, Congenital, Rehabilitation and Preschool Child, sponsored by Wei XIA, PhD. Not yet recruiting at 1 site in China. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Wei XIA, PhD · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
3 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Heart Defects, Congenital

1,007 studies on the registry are indexed under Heart Defects, Congenital; 256 are open to participants now.

This study's planned enrollment of 30 is below the median of 120 across 441 observational studies indexed under Heart Defects, Congenital.

Browse Heart Defects, Congenital studies →

Lead sponsor

Wei XIA, PhD is the lead sponsor of 13 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
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.

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: 12 months (from initiation to completion of scheme development)

07

Study locations

1 site
  • Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07055334
Lead sponsor
Wei XIA, PhD
Responsible party
Wei XIA, PhD (Associate professor, Sun Yat-sen University) — Sponsor-investigator
First posted
Jul 8, 2025
Start date
Jul 10, 2025 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 8, 2025

Study contacts

Xia Wei, PhD
Contact
xiaw23@mail.sysu.edu.cn
+8618823359471
Luo Cong, Master
Contact
luoc3@mail.sysu.edu.cn
+8619731525206
Xia Wei, PhD
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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