The Blended Care Intervention "Booster" for Youth With Chronic Health Conditions to Increase Fatigue-related Self-efficacy
NCT Number: NCT06562335
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fatigue|Chronic Illnesses
Interventions: OTHER: Booster
Sponsor: UMC Utrecht
Collaborators: Netherlands Organisation for Scientific Research
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-15
Completion Date: 2025-10-01
Locations: Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, Netherlands

Summary:
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.

Primary Outcome Measures: Fatigue-related self-efficacy, 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., Daily before and during the intervention, for approximately 130 days
Secondary Outcome Measures: Fatigue severity, pediatric short fatigue questionnaire, 4-item questionnaire, answered on a seven point Likert scale (1 = yes that is true, 7=no, that is not true). Total score ranges from 4 to 28, with higher scores reflecting more fatigue., Daily before and during the intervention, for approximately 130 days|Participation, School or work presence. Calculated: (hours present/the hours scheduled)\*100, Daily before and during the intervention, for approximately 130 days|Life satisfaction, Cantril Ladder, single-item question, rate life with ladder numbered from 0 to 10. Top of the ladder (10) represents the best possible life. The bottom (0) represents the worst possible life., Daily before and during the intervention, for approximately 130 days|Perceived health, EuroQol (EQ) visual analogue scale (VAS), ranging from 0 (worst health you can imagine) to 100 (best health you can imagine)., Daily before and during the intervention, for approximately 130 days
Other Outcome Measures: Fatigue-related self-efficacy, Self-Efficacy Scale-28 (SES-28) , 7-item questionnaire answered on a four-point likert scale, total scores range from 7 to 28 with higher scores indicating higher sense of control over fatigue., Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months|Fatigue, PEDsQL-MFS, 23-item questionnaire, Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months|Fatigue, Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale (PEDsQL-MFS), 24-item questionnaire answered on a five-point likert (0=never, 4 = almost always), total score ranging from 0 to 96, with higher scores representing more fatigue., Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months|Health-related quality of life, Pediatric Quality of Life Inventory-Generic Core Scales (PEDsQL-GCS), a 23-item questionnaire answered on a five-point likert (0=never, 4 = almost always), total score ranging from 0 to 92, with higher scores representing higher quality of life. The questionnaire has the following subscales: physical, emotional, social and school or work functioning., Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months|Health-related quality of life, Child Health Utility Index 9D (Chu9d), nine-item questionnaire answered on a five-point likert (0 to 4), total score ranging from 0 to 36, higher scores representing lower quality of life. The Chu9D has utility values that enable calculating quality adjusted life years., Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months|Health-related quality of life, EuroQol Five Dimensions Health Questionnaire Youth (EQ-5D-Y-3L), five-item questionnaire answered on a three point likert (no problems (1), some problems(2), a lot of problems(3)), total score ranging from 5 to 15, higher scores representing lower quality of life. The EQ-5D-Y-3L has utility values that enable calculating quality adjusted life years., Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months|School or work absence, Single item question on average absence over past half a year in %, Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months|Illness identity - fatigue, Illness identity questionnaire (ILQ), a 25-item questionnaire, answered on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). It has the following subscales: engulfment (8 items, range 8 to 40), rejection (5 items, range 5 to 25), acceptance (5 items, range 5 to 25) and enrichment (7 items, range 7 to 35). Higher scores on subscales represent respectively higher engulfment, rejection, acceptance and enrichment. The questionnaire is adapted to specifically ask for illness identity regarding fatigue (e.g., I refuse to see my fatigue as part of myself), Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months|Mastery, Pearlin Schooler Mastery Scale, a seven-item questionnaire, answered on a four-point Likert scale, ranging from strongly disagree (1) to strongly agree (4). Total score ranges from 7 to 28, with higher scores reflecting higher levels of mastery., Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months|Physical activity, Physical Activity Questionnaire for Adolescents (PAQ-A), a nine-item questionnaire. The first eight items are answered on a five-point Likert scale, ranging from low (1) to high (5) levels of physical activity. The ninth item asks whether the past week's activity was typical, less than typical, or more than typical, to provide context for the responses.The total score is calculated by averaging the scores of the first 8 items, yielding a final score ranging from 1 to 5. Higher scores indicate higher levels of physical activity., Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months