Design and Application of a Home Care Mini-Program for Children With Congenital Heart Disease After Discharge: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Family Health Score
研究概览
简要总结
This is a single-blind, randomized controlled trial aimed at evaluating the effectiveness of a family-centered, WeChat-based home care mini-program for children after congenital heart disease (CHD) surgery. Given the chronic nature of post-operative CHD management and the significant stress placed on families, this study shifts from a deficit-based to a strengths-based perspective, guided by the Double ABC-X model. Children (≤12 years old) who have undergone CHD surgery and their primary caregivers will be recruited. Participants will be randomly assigned to either the intervention group, which uses the mini-program for health education, peer support, and physiological monitoring, or the control group, which receives routine telephone follow-up. The primary outcomes are family health (measured by the Family Health Scale), family stress, and the quality of life for both the child and caregivers. Secondary outcomes include physiological parameters such as the 6-minute walk test distance. The study aims to provide evidence for a scalable digital health intervention to support long-term family adaptation and child recovery.
详细描述
- Background and Rationale Congenital heart disease (CHD) is the most common birth defect globally, with a high prevalence in China. While surgical advances have significantly improved survival rates, CHD has transitioned into a chronic condition requiring long-term management. The post-discharge period places immense stress on families, affecting caregiver well-being, family functioning, and the child's recovery. Existing home care models often focus on the child's deficits or rely on resource-intensive methods (e.g., home visits). Guided by the Double ABC-X model of family adaptation, this study adopts a family strengths-based perspective. It aims to develop and test a digital, interactive home care mini-program designed to support family resources, promote positive adaptation, and improve health outcomes after CHD surgery.
- Study Objectives Primary Objective: To evaluate the effectiveness of a family-centered, WeChat-based home care mini-program on improving family health in households with children after CHD surgery.
Secondary Objectives: To assess the program's impact on: 1) reducing family stress, 2) enhancing the quality of life of both the child and primary caregivers, and 3) improving the child's physiological recovery indicators. 3. Study Design This is a prospective, two-arm, parallel-group, assessor-blinded, randomized controlled trial (RCT). Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. 4. Participants, Setting, and Timeline Participants: Families (the child who underwent surgery and their primary caregiver/parent) of children (≤12 years old) with CHD after surgical intervention.
Setting: Recruitment and baseline assessment will be conducted at a tertiary hospital in Yunnan Province, China. The intervention and follow-up will be home-based.
Sample Size: 210 families (105 per group), calculated with 80% power, a significance level of 0.05, an effect size (δ/σ) of 0.5, and accounting for 20% attrition.
Timeline:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the behavioral intervention (use of a specific WeChat mini-program), it was not feasible to blind the participants, care providers, or investigators. However, the outcomes assessors and data analysts were blinded to group allocation throughout the study.
入排标准
- 年龄范围
- 0 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- The child is ≤12 years old.
- •The child has been diagnosed with congenital heart disease (CHD) and is scheduled for or has undergone corrective surgery.
- •The child is in a stable medical condition (non-acute phase).
- •At least one primary caregiver (parent or sibling >12 years old) of the child agrees to participate.
- •The caregiver provides written informed consent to participate in the study.
排除标准
- •- The child has severe developmental defects.
- •The child has other major diseases that significantly affect quality of life.
- •The caregiver has visual, hearing, or cognitive impairments that hinder communication.
- •The caregiver has a diagnosed psychiatric disorder.
- •The caregiver is unconscious or otherwise unable to provide consent.
研究组 & 干预措施
Intervention Group
Participants receiving the WeChat mini-program intervention.
干预措施: Routine Care with Telephone Follow-up (Other)
Control Group
Participants receiving routine care with telephone follow-up.
干预措施: Home Care WeChat Mini-Program (Device)
结局指标
主要结局
Family Health Score
时间窗: Change from Baseline at 6 months post-discharge
Score on the Chinese version of the Family Health Scale (FHS).
Family Stress Score
时间窗: Change from Baseline at 6 months post-discharge
Score on the Congenital Heart Disease Family Stressor Scale.
Child's Quality of Life Score
时间窗: Change from Baseline at 6 months post-discharge
Score on the Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cardiac Module.
Caregiver's Quality of Life Score
时间窗: Change from Baseline at 6 months post-discharge
Score on the 36-Item Short Form Health Survey (SF-36).
次要结局
- Body Weight(Measured at 1, 3, and 6 months post-discharge)
- Left Ventricular Ejection Fraction(Measured at 6 months post-discharge)
研究者
ruijie YangLan
Graduate Student
First Affiliated Hospital of Kunming Medical University