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

NCT06562335 | Not Yet Recruiting

• 1 other identifier: 24U-0152
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Chronic Illnesses

Keywords

Chronic childhood disease; Fatigue; Self-efficacy; mHealth; Pediatrics; Single case

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fatigue severity

  Daily before and during the intervention, for approximately 130 days

• Participation

  Daily before and during the intervention, for approximately 130 days

• Life satisfaction

  Daily before and during the intervention, for approximately 130 days

• Perceived health

  Daily before and during the intervention, for approximately 130 days

Other Outcomes (10)

• Fatigue-related self-efficacy

  Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

• Fatigue

  Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

• Fatigue

  Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

Study Arms (1)

Booster intervention

EXPERIMENTAL

* Start conversation: participant personalises the Booster app, supported by the Booster practitioner * Measurement period: the participant fills out short repeated questionnaires 5 times daily for 4 weeks in the Booster app. This method is called experience sampling methodology (ESM). Questions are partially personalised to reflect factors that the participants believes are related to fatigue. Questions cover thoughts, feelings, and activities. * Insight conversation: the Booster practitioner discusses the analysed questionnaires with the participant. Together they set lifestyle goals based on the insight obtained. * Experiment period: the participant works on the lifestyle goals supported by the goal attainment module in the Booster app.

Other: Booster

Interventions

Booster OTHER

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

Also known as: PROfeel

Booster intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (1)

Wilhelmina Children's Hospital, University Medical Centre Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

• 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 DERIVED

Related Links

• eHealth Junior Consortium

MeSH Terms

Conditions

Fatigue; Chronic Disease

Interventions

Immunization, Secondary

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• SL Nijhof, MSC, M.D., PhD

  UMCU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MD Stutvoet, MSC, M.D.

CONTACT

+3188 755 5555; booster@umcutrecht.nl

A Vroegindeweij, MSC

CONTACT

+3188 755 5555

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatrician, Associate Professor

Model Details: multiple baseline single case experimental AB-phase design

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 20, 2024
• Study Start: September 15, 2024
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be avalaible after publication, and at least one year after the end of the eHealth Junior Consortium. Data remains available until the end of 2040.
• Access Criteria: Participants provide consent through a consent form, specifying whether their data can be used for other research. If consent is not given, participants can still participate in the study without their data being used in these additional research contexts. External researchers can apply for access to data via handing in their research proposal to the principal investigator of this study. Studies concerning youth with chronic illnesses, fatigue, and studies involving extensive repeated measurements may be eligible to use the data. Data will be anomised before sharing to ensure privacy of participants.

Locations

NL (1)