Clinical trial NCT06562335: The Blended Care Intervention "Booster" for Youth With Chronic Health Conditions to Increase Fatigue-related Self-efficacy
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fatigue
Chronic Illnesses
Keywords: Chronic childhood disease
Fatigue
Self-efficacy
mHealth
Pediatrics
Single case
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
First posted: 2024-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: multiple baseline single case experimental AB-phase design
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Fatigue-related self-efficacy
timeFrame: Daily before and during the intervention, for approximately 130 days
Secondary outcomes:
measure: Fatigue severity
timeFrame: Daily before and during the intervention, for approximately 130 days
measure: Participation
timeFrame: Daily before and during the intervention, for approximately 130 days
measure: Life satisfaction
timeFrame: Daily before and during the intervention, for approximately 130 days
measure: Perceived health
timeFrame: Daily before and during the intervention, for approximately 130 days
Other outcomes:
measure: Fatigue-related self-efficacy
timeFrame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
measure: Fatigue
timeFrame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
measure: Fatigue
timeFrame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
measure: Health-related quality of life
timeFrame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
measure: Health-related quality of life
timeFrame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
measure: Health-related quality of life
timeFrame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
measure: School or work absence
timeFrame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
measure: Illness identity - fatigue
timeFrame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
measure: Mastery
timeFrame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
measure: Physical activity
timeFrame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Locations:
city: Utrecht
country: Netherlands
facility: Wilhelmina Children's Hospital, University Medical Centre Utrecht
Study officials:
affiliation: UMCU
name: SL Nijhof, MSC, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: