Chronic Illnesses, Fatigue
Conditions
Keywords
Chronic childhood disease, Fatigue, Self-efficacy, mHealth, Pediatrics, Single case
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.
Interventions
OTHERBooster
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
Sponsors
Netherlands Organisation for Scientific Research
UMC Utrecht
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
multiple baseline single case experimental AB-phase design
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue-related self-efficacy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Life satisfaction | Daily before and during the intervention, for approximately 130 days | 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. |
| Fatigue severity | Daily before and during the intervention, for approximately 130 days | 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. |
| Participation | Daily before and during the intervention, for approximately 130 days | School or work presence. Calculated: (hours present/the hours scheduled)\*100 |
| Perceived health | Daily before and during the intervention, for approximately 130 days | EuroQol (EQ) visual analogue scale (VAS), ranging from 0 (worst health you can imagine) to 100 (best health you can imagine). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mastery | Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months | 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. |
| Fatigue-related self-efficacy | Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months | 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. |
| Physical activity | Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months | 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. |
| Fatigue | Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months | PEDsQL-MFS, 23-item questionnaire |
| Health-related quality of life | Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months | 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. |
| School or work absence | Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months | Single item question on average absence over past half a year in % |
| Illness identity - fatigue | Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months | 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) |
Countries
Netherlands
Contacts
Primary ContactMD Stutvoet, MSC, M.D.
Backup ContactA Vroegindeweij, MSC
Outcome results
None listed