Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT06562335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-23
First Post:
2024-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Blended Care Intervention "Booster" for Youth With Chronic Health Conditions to Increase Fatigue-related Self-efficacy
Sponsor:
UMC Utrecht
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: