Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562335
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
The Blended Care Intervention Booster for Youth With Chronic Health Conditions to Increase Fatigue-related Self-efficacy
Sponsor:
None
Organization:
None
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:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None