FatigueNCT06562335
The Blended Care Intervention "Booster" for Youth With Chronic Health Conditions to Increase Fatigue-related Self-efficacy
A study testing Booster in people with Fatigue and Chronic Illnesses, run by UMC Utrecht at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Fatigue, Chronic Illnesses
- What is being tested?
- Booster
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Sep 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
A Vroegindeweij, MSC contact
Netherlands1 site
Wilhelmina Children's Hospital, University Medical Centre Utrecht
Utrecht
MD Stutvoet, Msc, M.D., booster@umcutrecht.nl
About this study
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
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:
Read more
- 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
- Being tested
- Booster
- Keywords
- Chronic childhood disease, Fatigue, Self-efficacy, mHealth, Pediatrics, Single case
- Medical subject headings
- Fatigue, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoosterOther
Also called PROfeel
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily before and during the intervention, for approximately 130 days
Secondary outcomes (4)
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.
Measured: Daily before and during the intervention, for approximately 130 days
Participation
School or work presence. Calculated: (hours present/the hours scheduled)*100
Measured: 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.
Measured: 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).
Measured: Daily before and during the intervention, for approximately 130 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- multiple baseline single case experimental AB-phase design
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Responsible party
- Principal investigator, Sanne Nijhof, UMC Utrecht
- Investigators
- SL Nijhof, MSC, M.D., PhD, Principal investigator, UMCU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562335
- Sponsor's protocol ID
- 24U-0152
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anomised individual participant data will be shared on request (see access criteria).
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.
PubMed 40708017
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06562335
- Acronym / sponsor ID
- 24U-0152
- Conditions
- Fatigue, Chronic Illnesses
- Keywords
- Chronic childhood disease, Fatigue, Self-efficacy, mHealth, Pediatrics, Single case
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multiple baseline single case experimental AB-phase design
| Arm | Type | Receives |
|---|---|---|
| Booster intervention | Experimental | Other: Booster* 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
- Cognitive impairment with an estimated IQ of below 70
- No smartphone with internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BoosterAlso: PROfeelSee 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 | Booster intervention |
Primary outcome
Fatigue-related self-efficacy
Time frame: Daily before and during the intervention, for approximately 130 days
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.
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 40708017Stutvoet 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.
- eHealth Junior ConsortiumLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anomised individual participant data will be shared on request (see access criteria).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Vroegindeweij, MSC contact
SL Nijhof, MSC, M.D., PhD principal investigator
UMCU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Booster in people with Fatigue and Chronic Illnesses, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MD Stutvoet, MSC, M.D. (+3188 755 5555, booster@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue-related self-efficacy (time frame: Daily before and during the intervention, for approximately 130 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06562335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.