Blended Therapy for Youth With a Chronic Health Condition to Increase Fatigue-related Self-efficacy (Booster): Protocol for a Multiple Baseline Single Case Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- UMC Utrecht
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fatigue-related self-efficacy
研究概览
简要总结
The goal of this experimental study is to learn if the Booster intervention can be used as an early intervention for persistent fatigue. The aim of the intervention is to prevent more fatigue-related disabilities in young people with chronic illnesses like inflammatory bowel disease, childhood cancer, and juvenile idiopathic arthritis by improving self-confidence in managing fatigue (fatigue-related self-efficacy or FSE).
The main questions this study aims to answer are:
- What is the effect of the Booster intervention on fatigue-related self-efficacy (FSE)?
- What is the effect of the Booster intervention on fatigue levels, school participation, life satisfaction, and perceived health?
- When does improvement in study outcomes happen relative to the Booster intervention?
- What participant characteristics predict change in study outcomes?
Participants will follow the Booster intervention. Booster is a personalised, blended care intervention designed to help young people understand how their thoughts, feelings, and activities impact their fatigue using a smartphone app. The Booster app uses experience sampling methodology (ESM) to track these fluctuations. Based on insights obtained from these data, the participant and their healthcare provider can set personal lifestyle goals, such as increasing physical activity and reducing daytime naps. An earlier version of this intervention, called PROfeel, was effective in reducing severe fatigue. The investigators have now improved the app to also help with setting and achieving personal goals and monitoring daily progress.
The investigators will measure the effect of Booster through daily questionnaires during two phases: Phase A (baseline, before the goal setting between patient and healthcare provider) and Phase B (intervention, starting in the lifestyle change period). The duration of Phase A will be randomised for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Experiencing fatigue for at least 3 months and feeling hindered by it (Pediatric Short Fatigue Questionnaire (pSFQ) score of 15 or higher)
- •Diagnosed with a chronic health condition or treated for childhood cancer
排除标准
- •Regarding other treatments:
- •Fatigue fully explained by a somatic or psychiatric diagnosis
- •Chronic health condition unstable in the last 3 months (e.g., recent medication changes or cancer relapse)
- •Significant functional limitations due to fatigue (e.g., more than 50% school absenteeism)
- •Regarding feasibility:
- •Cognitive impairment with an estimated IQ of below 70
- •No smartphone with internet access
- •Unable to speak, read, understand, or write Dutch
结局指标
主要结局
Fatigue-related self-efficacy
时间窗: Daily before and during the intervention, for approximately 130 days
Single-item question, self-report via Booster app. The single item was designed and validated for this study. Answered on a VAS scale 0 to 100. Higher score represents higher fatigue-related self-efficacy.
次要结局
- Participation(Daily before and during the intervention, for approximately 130 days)
- Fatigue severity(Daily before and during the intervention, for approximately 130 days)
- Perceived health(Daily before and during the intervention, for approximately 130 days)
- Life satisfaction(Daily before and during the intervention, for approximately 130 days)
研究者
Sanne Nijhof
Principal Investigator, Pediatrician, Associate Professor
UMC Utrecht