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Набор скоро начнётся NCT06562335

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

Без фазы С лечением Fatigue Chronic Illnesses

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Booster.
Кому может быть актуально
Состояния в реестре: Fatigue, Chronic Illnesses. Базовые параметры: 12 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Другое 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

Первичные конечные точки

  • Fatigue-related self-efficacy [Срок оценки: Daily before and during the intervention, for approximately 130 days]
Вторичные конечные точки (4)
  • Fatigue severity [Срок оценки: Daily before and during the intervention, for approximately 130 days]
  • Participation [Срок оценки: Daily before and during the intervention, for approximately 130 days]
  • Life satisfaction [Срок оценки: Daily before and during the intervention, for approximately 130 days]
  • Perceived health [Срок оценки: Daily before and during the intervention, for approximately 130 days]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Нидерланды · 1 центр
  • Wilhelmina Children's Hospital, University Medical Centre Utrecht — Utrecht

Публикации

  • 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

Идентификаторы

NCT: NCT06562335 · 24U-0152

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗