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Идёт набор NCT06741475

Feasibility Study of Caregiver-Assist Strategy Training

Без фазы С лечением Stroke

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: Caregiver-Assist Strategy Training, Education.
Кому может быть актуально
Состояния в реестре: Stroke. 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Optimizing Activity Performance of Stroke Patients Through Caregiver-Assisted Rehabilitation With Strategy Training: A Feasibility Study

Обзор

The goal of this study is to examine the feasibility of delivering an innovative intervention, caregiver-assisted strategy training (CaST), targeting enhancing activity functions in community-dwelling adults after stroke. The main questions it aims to answer are: * Is CaST acceptable to stroke survivors with functional limitations? * Does CaST show positive effects on functional outcomes? Researchers will compare the CaST program to a control education program to investigate the interventional effect size for the selected stroke participants. Participants will: * Receive CAST or an education program 1 to 2 sessions per week until finishing 10 sessions. * Be assessed clinical outcomes at 4 times: pre-intervention, post-intervention, 3-month, and 6-month follow-up. * Be interviewed once after finishing their intervention.

Подробное описание

To address post-stroke activity limitations, intensive task-oriented rehabilitation is widely recommended across clinical guidelines. The caregiver is potentially able to play a facilitative role during the rehabilitation process. However, the best way to integrate caregivers into task-oriented rehabilitation is largely unknown. To address this gap, this preliminary study aims to assess the feasibility of a newly developed intervention, caregiver-assisted strategy training (CaST), in enhancing the activity performance of stroke survivors.

A mixed-methods (quantitative and qualitative) design, including a repeated measures design, is used in this feasibility study. A procedure of randomization with minimization will be conducted by a researcher who is independent of the investigation and outcome assessments. Eligible stroke survivors and their caregivers will be recruited from collaborative hospitals in Northern Taiwan and randomly assigned with even possibility. Longitudinal evaluations will be conducted at baseline (T1), post-intervention (T2), 3-month (T3), and 6-month (T4) follow-ups. Standardized assessments such as the Activity Measure for Post-Acute Care (AMPAC), the Participation Measure-3 Domains, 4 Dimensions (PM-3D4D), EuroQol-5D (EQ-5D), Stroke Self-Efficacy Questionnaires (SSEQ), Fugl-Meyer Assessment (FMA), Montreal Cognitive Assessment (MoCA), and Goal Attainment Scaling (GAS) will be used to assess outcomes at baseline, post-intervention, and 3-month and 6-month follow-ups. The feasibility indicators, such as recruitment rates and intervention attendance and adherence, will be evaluated by questionnaires, field notes, and qualitative interviews after the interventions are completed. Quantitative data will be analyzed using multiple linear regression models and mixed-effects regression models. Furthermore, qualitative in-depth interviews with participants, caregivers, and therapists will be conducted post-intervention. These interviews will explore experiences, satisfaction, and perceived effectiveness of the intervention. Transcribed data will undergo coding by two independent coders and subsequent analysis through the thematic analysis method.

Вмешательства

  • Поведенческое Caregiver-Assist Strategy Training
    CaST is a home-based rehabilitation that guides both stroke survivors and their caregivers to implement strategy training for addressing real-life limitations after stroke. During the intervention, the caregiver not only supervises the participant but also co-participates in the practice by instructing on when and how to be an assistant and facilitator when the stroke survivor executes their practice plan.
  • Поведенческое Education
    Stroke-related information and knowledge that includes stroke subtypes and their etiology, risk factors of primary and secondary stroke, healthy lifestyles, common sequela, and adaptive skills for impaired functions are provided.

Первичные конечные точки

  • Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms [Срок оценки: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)]
Вторичные конечные точки (7)
  • Participation Measure-3 Domains, 4 Dimensions (PM-3D4D) [Срок оценки: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)]
  • EuroQol-5D-3L (EQ-5D-3L) [Срок оценки: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)]
  • Stroke Self-Efficacy Questionnaires (SSEQ) [Срок оценки: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)]
  • Fugl-Meyer Assessment (FMA) [Срок оценки: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)]
  • Montreal Cognitive Assessment (MoCA) [Срок оценки: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)]
  • Goal Attainment Scale [Срок оценки: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)]
  • Client Satisfaction Questionnaire [Срок оценки: At the end of intervention, 5 to 10 weeks from the baseline]

Критерии участия

Критерии включения

  • Being willing to provide informed consent
  • Diagnosis with ischemic and/or hemorrhagic stroke
  • Modified Rankin Scale (mRS) ranges from 2 to 4
  • Rehabilitation frequency less than 3 days per week
  • Having a healthy caregiver

Критерии исключения

  • Undergoing palliative care
  • Major diseases or severe conditions influencing study participation, such as global aphasia, dementia, multiple organ failure, immobilization due to fracture, etc Moderate post-stroke cognitive impairment, with Montreal Cognitive Assessment score <22
  • Pre-stroke mRS > 1
  • Participating in other interventional study concurrently.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

Тайвань · 3 центра
  • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare — New Taipei City
  • Taipei Medical University Hospital — Taipei
  • Taipei Municipal Wanfang Hospital — Taipei

Идентификаторы

NCT: NCT06741475 · N202407030

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗