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Not yet recruiting NCT07055347

Feasibility Study of Home Cardiac Rehabilitation Program for Postoperative Children With Congenital Heart Disease

No phase Interventional Congenital Heart Disease (CHD) Preschool Children Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers.
Who it may be relevant to
Registry conditions: Congenital Heart Disease (CHD), Preschool Children, Rehabilitation. Basic parameters: 3 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This single-arm feasibility study will pilot a home-based cardiac rehabilitation program for preschool children (aged 3 to 7 years) who have undergone corrective surgery for congenital heart disease. Following the development of the program through expert consensus, this phase will implement the preliminary version of the program in a selected sample of caregiver-child pairs over a 12-week period. The study will assess feasibility by evaluating caregiver adherence to the intervention, acceptability of the program components, and completeness of rehabilitation task records. Descriptive data on safety, participation rate, and delivery logistics will also be collected. Findings will inform refinement of the program prior to future effectiveness testing.

Interventions

  • Other Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers
    Intervention Description: For children, provide age-appropriate rehab manuals with pictures and texts to encourage participation. Include gentle physical activities, breathing and stretching exercises. For caregivers, offer detailed manuals and checklists. Organize training. Manage drugs with personalized guidance. Provide health education for both via manuals and video consultations. Focus on mental and physical health with support and activities. Regular phone follow-ups ensure nursing continu

Primary outcome measures

  • Caregiver Adherence Rate to the Home Rehabilitation Program [Time frame: Up to 4 weeks post-enrollment (exact duration to be finalized)]
Secondary outcome measures (2)
  • Rehabilitation Program Data [Time frame: At 7 and 14 days after implementation]
  • Feedback survey [Time frame: At 7 and 14 days after implementation]

Eligibility criteria

Children With Congenital Heart Disease After Surgery

Inclusion criteria

  • Meet the diagnostic criteria for congenital heart disease
  • Aged between 3 and 7 years
  • Underwent open-heart congenital heart disease correction surgery at the research institution and achieved correction in a single surgery
  • Have been discharged after completing inpatient postoperative rehabilitation
  • Able to communicate in Chinese

Exclusion criteria

  • Postoperative arrhythmia
  • Neurological, respiratory, or other comorbid diseases in addition to congenital heart disease and assessed by a physician as unsuitable for exercise
  • 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

  • The primary caregiver of the child, limited to the child's father or mother
  • Among parents, the one who has provided care for the longest duration
  • Able to communicate in Chinese

Exclusion criteria

  • Caregivers of children who voluntarily discontinued treatment before its completion
  • Paid or non-parental caregivers
  • Individuals with diagnosed cognitive impairment or mental illness
  • Inability to communicate effectively through spoken language
  • Serious conflict or instability in the caregiver-child relationship
  • Inability to independently operate and use smart electronic devices and internet-based tools

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07055347 · LSLL2024-801-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗