Long-term Effects of Family WISH Program for Adolescents 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
- 104
- 试验地点
- 2
- 主要终点
- frailty state
研究概览
简要总结
The goal of this clinical trial is to learn the long-term effects of "Family Walking Instruction with Support by Heart" (Family WISH) on frailty state, quality of life and family functioning among adolescents with congenital heart disease (CHD).
Researchers will compare the 12-week Family WISH program, based on self-efficacy theory, to a comparison group receiving a family walking health education sheet to evaluate the long-term effectiveness of the Family WISH program.
Participants will:
- Walk with family members for 20-30 minutes daily, at least 5 times per week, totaling 150 minutes per week.
- Keep a diary to record the frequency of their walks and any symptoms experienced.
- Complete questionnaires at baseline, and at 6, 12, and 24 weeks.
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
To ensure assessor blinding, different personnel conducted the interventions and outcome assessments.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being between 12 and 18 years old;
- •having received a diagnosis of CHD by a physician before age 2;
- •having received a diagnosis of CHD with New York Heart Association (NYHA) functional class I, II, or III;
- •having parents or guardians who were able to communicate in Mandarin, and being able to communicate in Mandarin themselves;
- •not having cognitive impairments, and;
- •voluntarily signing informed consent forms.
排除标准
- •undergoing heart transplant surgery within the past year;
- •receiving cardiac catheterization intervention or open-heart surgery within the past 6 months;
- •having CHD with NYHA functional class IV; and
- •having other congenital diseases
研究组 & 干预措施
Experimental group
Experimental group: a 12-week Family WISH program
Comparison group
Comparison group: a family walking health education sheet received
干预措施: Comparison group (Behavioral)
结局指标
主要结局
frailty state
时间窗: at baseline, and at 6, 12, and 24 weeks
self-reported questionnaire completed
次要结局
- quality of life and family functioning(at baseline, and at 6, 12, and 24 weeks)
研究者
Chi-Wen Chen
Professor
National Yang Ming Chiao Tung University