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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue; Chronic Illnesses
• Intervention / Treatment: Other: Booster

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MD Stutvoet, MSC, M.D.; Phone Number: +3188 755 5555; Email: booster@umcutrecht.nl
• Study Contact Backup: Name: A Vroegindeweij, MSC; Phone Number: +3188 755 5555

Study Locations

• Netherlands
  • Utrecht, Netherlands
    • Wilhelmina Children's Hospital, University Medical Centre Utrecht
    • Contact: MD Stutvoet, Msc, M.D.; Email: booster@umcutrecht.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Booster intervention; 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; 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; Other Names: PROfeel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue severity	pediatric short fatigue questionnaire, 4-item questionnaire, answered on a seven point Likert scale (1 = yes that is true, 7=no, that is not true). Total score ranges from 4 to 28, with higher scores reflecting more fatigue.	Daily before and during the intervention, for approximately 130 days
Participation	School or work presence. Calculated: (hours present/the hours scheduled)*100	Daily before and during the intervention, for approximately 130 days
Life satisfaction	Cantril Ladder, single-item question, rate life with ladder numbered from 0 to 10. Top of the ladder (10) represents the best possible life. The bottom (0) represents the worst possible life.	Daily before and during the intervention, for approximately 130 days
Perceived health	EuroQol (EQ) visual analogue scale (VAS), ranging from 0 (worst health you can imagine) to 100 (best health you can imagine).	Daily before and during the intervention, for approximately 130 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue-related self-efficacy	Self-Efficacy Scale-28 (SES-28) , 7-item questionnaire answered on a four-point likert scale, total scores range from 7 to 28 with higher scores indicating higher sense of control over fatigue.	Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Fatigue	PEDsQL-MFS, 23-item questionnaire	Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Fatigue	Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale (PEDsQL-MFS), 24-item questionnaire answered on a five-point likert (0=never, 4 = almost always), total score ranging from 0 to 96, with higher scores representing more fatigue.	Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Health-related quality of life	Pediatric Quality of Life Inventory-Generic Core Scales (PEDsQL-GCS), a 23-item questionnaire answered on a five-point likert (0=never, 4 = almost always), total score ranging from 0 to 92, with higher scores representing higher quality of life. The questionnaire has the following subscales: physical, emotional, social and school or work functioning.	Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Health-related quality of life	Child Health Utility Index 9D (Chu9d), nine-item questionnaire answered on a five-point likert (0 to 4), total score ranging from 0 to 36, higher scores representing lower quality of life. The Chu9D has utility values that enable calculating quality adjusted life years.	Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Health-related quality of life	EuroQol Five Dimensions Health Questionnaire Youth (EQ-5D-Y-3L), five-item questionnaire answered on a three point likert (no problems (1), some problems(2), a lot of problems(3)), total score ranging from 5 to 15, higher scores representing lower quality of life. The EQ-5D-Y-3L has utility values that enable calculating quality adjusted life years.	Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
School or work absence	Single item question on average absence over past half a year in %	Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Illness identity - fatigue	Illness identity questionnaire (ILQ), a 25-item questionnaire, answered on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). It has the following subscales: engulfment (8 items, range 8 to 40), rejection (5 items, range 5 to 25), acceptance (5 items, range 5 to 25) and enrichment (7 items, range 7 to 35). Higher scores on subscales represent respectively higher engulfment, rejection, acceptance and enrichment. The questionnaire is adapted to specifically ask for illness identity regarding fatigue (e.g., I refuse to see my fatigue as part of myself)	Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Mastery	Pearlin Schooler Mastery Scale, a seven-item questionnaire, answered on a four-point Likert scale, ranging from strongly disagree (1) to strongly agree (4). Total score ranges from 7 to 28, with higher scores reflecting higher levels of mastery.	Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Physical activity	Physical Activity Questionnaire for Adolescents (PAQ-A), a nine-item questionnaire. The first eight items are answered on a five-point Likert scale, ranging from low (1) to high (5) levels of physical activity. The ninth item asks whether the past week's activity was typical, less than typical, or more than typical, to provide context for the responses.The total score is calculated by averaging the scores of the first 8 items, yielding a final score ranging from 1 to 5. Higher scores indicate higher levels of physical activity.	Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: Netherlands Organisation for Scientific Research
• Investigators: Principal Investigator: SL Nijhof, MSC, M.D., PhD, UMCU

Publications and helpful links

Helpful Links

• eHealth Junior Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Fatigue; Pediatrics; mHealth; Self-efficacy; Single case; Chronic childhood disease
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Fatigue; Chronic Disease
• Other Study ID Numbers: 24U-0152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anomised individual participant data will be shared on request (see access criteria).
• IPD Sharing 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.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No