Feasibility of a Group-Based Intervention to Enhance Health-Related Quality of Life and Physical Activity in Children and Adolescents With Chronic Illness: A Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Proportion of completed components
研究概览
简要总结
The goal of this observational study is to evaluate the feasibility of the intervention Life Coping Program in children and adolescents 8-16 years of age. The main question it aims to answer is:
Is the Life Coping Program in its current form feasible among children and adolescents with a variety of primary conditions?
The health care providers of participants already undergoing the Life Coping Program will answer survey questions after key procedures of the intervention, and the research team will be given access to measures provided by the participants.
详细描述
Feasibility and acceptability of the intervention Life Coping Program will be evaluated in an uncontrolled open-label trial using quantitative measures. Sixty children or adolescents with chronic illness or severe medical condition will be recruited along with one associated caregiver. Feasibility will be assessed by tracking attendance and participation in different parts of the intervention. Acceptability of the intervention will be assessed using patient reported experience measures (PREM). Health related quality of life (HrQoL) and level of physical activity will be measured using the Kidscreen 27 and Actigraph GT3X+ monitor, respectively, at baseline and post-intervention.
The study is based on the British Medical Research Council's (MRC) framework for developing and evaluating complex interventions, and will explore innovative treatment strategies that could potentially improve current clinical outcomes and reduce the need for ongoing healthcare follow-up. The findings from this feasibility study will lay the groundwork for a future definitive randomized controlled trial in accordance with the MRC framework for developing and evaluating complex interventions.
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
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have received treatment at Haukeland University Hospital
- •One or more of the following primary conditions: congenital heart defects, congenital oral clefts, premature birth before 32 weeks of gestation, completion of cancer treatment, chronic pain conditions, or significant burn injuries
- •Must be able to answer questionnaires in Norwegian
排除标准
- •Medical condition that may hinder og alter participation
- •Treatment plan that may hinder or alter participation
结局指标
主要结局
Proportion of completed components
时间窗: From enrollment to 6 months after the 5-day Life Coping Course
The proportion of completed components of the Life Coping Program per participant, as reported on checklists completed by health personnel, fully completed questionnaires by participants, and successful use of activity monitors.
Checklist for health personnel
时间窗: Immediately after the procedures
Based on the work of Bellg et al. (2004) and Husted et al. (2014), purpose-built checklists are designed for four pre-defined key procedures of the intervention; 1. Primary digital consultation, 2. primary individual consultation during the Life Coping Course, 3. Activities during the Life Coping Course, and 4. The digital follow-up consultation 3-4 weeks after.
次要结局
- Evaluation of the Life Coping Course(Immediately after the procedure)
- Health related Quality of Life(From enrollment to 3-4 weeks and 6 months after the 5-days Life Coping Course)
- Activity Levels(From enrollment to 6 months after the 5-days Life Coping Course)
- Self-reported activity levels and satisfaction with relevant activities(From enrollment to 3-4 weeks and 6 months after the five-day Life Coping Course.)