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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Caregiver Adherence Rate to the Home Rehabilitation Program [Срок оценки: Up to 4 weeks post-enrollment (exact duration to be finalized)]

Вторичные конечные точки (2)

• Rehabilitation Program Data [Срок оценки: At 7 and 14 days after implementation]
• Feedback survey [Срок оценки: At 7 and 14 days after implementation]

Критерии участия

Children With Congenital Heart Disease After Surgery

Критерии включения

• 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

Критерии исключения

• 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

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07055347 · LSLL2024-801-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗