Меню
Идёт набор NCT06058351

ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury

Без фазы С лечением Acquired Brain Injury

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: ABI-motion program.
Кому может быть актуально
Состояния в реестре: Acquired Brain Injury. Базовые параметры: от 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 →
Официальное название

ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury; an Implementation Study

Обзор

The goal of this implementation study is to improve aftercare for patients with ABI receiving outpatient rehabilitation. The ABI-motion program was developed to improve and active lifestyle and to prevent persistent complaints after ABI and poor HR-QoL.The main questions it aims to answer are: * Is the ABI-motion program feasible? * What are the health benefits of the ABI-motion program? Participants will receive brain education, a joint therapy session with a physical or occupational or movement therapist and a buddy from a patient support organization during outpatient rehabilitation, followed by community buddy support after discharge from outpatient rehabilitation, and follow-up by a rehabilitation physician.

Подробное описание

Rationale: Many people with acquired brain injury (ABI) experience difficulties in reintegration into their social life after discharge from the rehabilitation center. It is also known that people with ABI do not meet the physical activity guidelines; they have lower physical activity levels than healthy people and they have difficulty maintaining their physical fitness level reached during rehabilitation. An inactive lifestyle may lead to persistent complaints, such as fatigue, anxiety or depression, and may result in a poor health-related quality of life (HR-QoL).

Objective: To improve aftercare for patients with ABI receiving outpatient rehabilitation, aimed at promoting an active lifestyle to prevent persistent complaints after ABI and poor HR-QoL.

Study design: Care improvement study using a prospective mono-center cohort with a pre-post implementation study design.

Study population: Patients with ABI receiving outpatient rehabilitation therapy.

Intervention (if applicable): Implementation of an aftercare program that strengthens the cooperation between rehabilitation center and local patient support organisations in the community. The aftercare program integrates standard outpatient rehabilitation and community services, including: 1) brain education regarding long-term consequences of ABI, physical activity guidelines, and patient support organizations in the area; 2) a joint physical/ occupational/ movement therapy session with a buddy from a patient support organisation during outpatient rehabilitation; 3) buddy support (max 8 hrs) in the community towards an active lifestyle after rehabilitation discharge; 4) follow-up by the rehabilitation physician.

Main study parameters/endpoints: The proportion of participants with ABI participating in the community buddy program (target 60%) and feasibility (rating of satisfaction) of the program will be calculated. Secondary, objectively measured physical activity, physical fitness and cognitive functioning and patient reported outcomes (physical activity, fatigue, anxiety, depression, cognitive complaints, coping, community integration, HRQoL, physical fitness, health care use, return to work) using validated questionnaires will be collected before and at 3, 6, and 12 months after outpatient rehabilitation discharge.

Вмешательства

  • Поведенческое ABI-motion program
    The ABI-motion program strengthens the cooperation between outpatient rehabilitation professionals and community care providers.

Первичные конечные точки

  • Difference in proportion of patients participating in buddy support programs after rehabilitation discharge [Срок оценки: 3, 6, 12 months]
  • Mean rating of satisfaction with the ABI-motion program [Срок оценки: 12 months]
Вторичные конечные точки (12)
  • Change in total minutes of physical activity/week at 6 and 12 months compared with controls [Срок оценки: 0, 6, 12 months]
  • Change in Montreal Cognitive Assessment (MoCA) score at 6 and 12 months compared with controls. [Срок оценки: 0, 6,12 months]
  • Change in functional exercise capacity at 6 and 12 months compared with controls [Срок оценки: 0, 6, 12 months]
  • Change in Walking Speed at 6 and 12 months compared with controls [Срок оценки: 0, 6, 12 months]
  • Change in handgrip strength at 6 and 12 months compared with controls [Срок оценки: 0, 6, 12 months]
  • Change in anxiety and depression at 3, 6, and 12 months compared with controls [Срок оценки: 0, 3, 6, and 12 months]
  • Change in fatigue at 3, 6, and 12 months compared with controls [Срок оценки: 0, 3, 6, and 12 months]
  • Change in cognitive failures at 3, 6, and 12 months compared with controls [Срок оценки: 0, 3, 6, and 12 months]
  • Change in coping style at 3, 6, and 12 months compared with controls [Срок оценки: 0, 3, 6, and 12 months]
  • Change in health-related quality of life at 3, 6, and 12 months compared with controls [Срок оценки: 0, 3, 6, 12 months]
  • Change in physical and mental components of health-related quality of life at 3, 6, and 12 months compared with controls [Срок оценки: 0, 3, 6, 12 months]
  • Change in physical activity at 3, 6,12 months compared with controls [Срок оценки: 0, 3, 6, 12 months]

Критерии участия

Критерии включения

  • Diagnosed with ABI
  • Follows an outpatient rehabilitation program for ABI in Rijndam Rehabilitation

Критерии исключения

  • Having a contra-indication for participation in moderate to vigorous exercise
  • Life expectancy < 1 year
  • Incapacitated persons

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Нидерланды · 1 центр
  • Rijndam Rehabilitation — Rotterdam

Публикации

  • de Vries EA, Grauwmeijer E, Ista E, Blom-De Heer SJ, Cramm JM, Ribbers GM, van den Berg-Emons RJG, Heijenbrok-Kal MH. A multidisciplinary active lifestyle aftercare programme for individuals with acquired brain injury (ABI-MOTION): protocol of a practice-based implementation study. BMJ Open. 2026 Jul 13;16(7):e118358. doi: 10.1136/bmjopen-2026-118358. PMID 42442820

Идентификаторы

NCT: NCT06058351 · 11172

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗