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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsorWei XIA, PhD

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Postoperative arrhythmia

Comorbid neurological, respiratory, or other systemic diseases

Deemed unsuitable for exercise by a physician

Cardiac function classified as NYHA Class IV

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

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Wei XIA, PhD

Lead sponsor

Sun Yat-sen University

Sponsor institution

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