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Not yet recruiting NCT06562335

The Blended Care Intervention "Booster" for Youth With Chronic Health Conditions to Increase Fatigue-related Self-efficacy

No phase Interventional Fatigue Chronic Illnesses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Booster.
Who it may be relevant to
Registry conditions: Fatigue, Chronic Illnesses. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Other Booster
    See description of arm. The Booster intervention has evolved from the PROfeel intervention. PROfeel is described in: https://doi.org/10.1186/s13063-022-06620-2

Primary outcome measures

  • Fatigue-related self-efficacy [Time frame: Daily before and during the intervention, for approximately 130 days]
Secondary outcome measures (4)
  • Fatigue severity [Time frame: Daily before and during the intervention, for approximately 130 days]
  • Participation [Time frame: Daily before and during the intervention, for approximately 130 days]
  • Life satisfaction [Time frame: Daily before and during the intervention, for approximately 130 days]
  • Perceived health [Time frame: Daily before and during the intervention, for approximately 130 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Netherlands · 1 center
  • Wilhelmina Children's Hospital, University Medical Centre Utrecht — Utrecht

Publications

  • Stutvoet MD, Vroegindeweij A, Houtveen J, van Litsenburg RRL, van de Putte E, Veltkamp RC, Nijhof SL. Blended therapy for adolescents with chronic health conditions to increase fatigue-related self-efficacy (Booster): protocol for a single-case multiple baseline study. Trials. 2025 Jul 24;26(1):255. doi: 10.1186/s13063-025-08960-1. PMID 40708017

Identifiers

NCT: NCT06562335 · 24U-0152

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗