Feasibility Study of Home Cardiac Rehabilitation Program for Postoperative Children With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 主要终点
- Caregiver Adherence Rate to the Home Rehabilitation Program
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Home-based cardiac rehabilitation group
Participants in this arm will receive a structured home-based cardiac rehabilitation program designed for preschool children (aged 3-7 years) who have undergone corrective surgery for congenital heart disease. The program includes modules on physical activity, breathing exercises, emotional support, and caregiver education. Caregivers will implement the 12-week intervention at home with support materials and guidance provided by the research team.
干预措施: Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers (Other)
结局指标
主要结局
Caregiver Adherence Rate to the Home Rehabilitation Program
时间窗: Up to 4 weeks post-enrollment (exact duration to be finalized)
During the pilot implementation phase of the home-based rehabilitation program, caregivers will be asked to assist their children in completing assigned daily tasks (e.g., physical activities, breathing exercises, emotional support). Adherence will be tracked using daily caregiver logs. The outcome will be calculated as the percentage of completed tasks over the total assigned tasks per participant. Summary statistics (mean ± SD) will be reported.
Caregiver Adherence Rate to the Home Rehabilitation Program
时间窗: Up to 4 weeks post-enrollment (exact duration to be finalized)
During the pilot implementation phase of the home-based rehabilitation program, caregivers will be asked to assist their children in completing assigned daily tasks (e.g., physical activities, breathing exercises, emotional support). Adherence will be tracked using daily caregiver logs. The outcome will be calculated as the percentage of completed tasks over the total assigned tasks per participant. Summary statistics (mean ± SD) will be reported.
次要结局
- Rehabilitation Program Data(At 7 and 14 days after implementation)
- Feedback survey(At 7 and 14 days after implementation)
- Rehabilitation Program Data(At 7 and 14 days after implementation)
- Feedback survey(At 7 and 14 days after implementation)
研究者
Wei XIA, PhD
Association Professor
Sun Yat-sen University