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Идёт набор NCT05999929

Memory Support System Feasibility Study

Без фазы С лечением Mild Cognitive Impairment

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: Memory Support System.
Кому может быть актуально
Состояния в реестре: Mild Cognitive Impairment. Базовые параметры: от 50 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
Канада
Следующий шаг
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Официальное название

Implementation of the Memory Support System: A Feasibility Study

Обзор

The purpose of this study is to determining the feasibility of providing the Memory Support System (MSS) to individuals with mild cognitive impairment (MCI) and their partners at a clinic in Ontario, Canada. This will involve a) collecting information from patients referred to the a memory clinic and geriatric day hospital about the patient's interest in and the patient's preferred method to administer the MSS; and b) a cost analysis related to implementation of the MSS. The study will also measure efficacy outcomes of the MSS regarding program adherence as well as to self-reported IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden among a sample of individuals with MCI and their care partners

Подробное описание

A survey will be created and sent out to participants with MCI who have expressed interest in participating in research and have been seen at a memory clinic or geriatric day hospital after the initiation of the study. The survey will consist of a Likert scale and open questions related to patient interest in and preferred length of MSS administration and preference for in-person versus virtual administration.

During and after collection of the survey data, a sample of 20 individuals with MCI (ages ≥50) and their care partners will undergo MSS training.

At enrollment in the MSS training, participants with MCI and their care partners will complete measures of cognitive and functional status. Participants and partners will also complete measures of treatment adherence, IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden at baseline, treatment end, and 8-week follow-up. Participants will complete the MSS training consisting of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after initial assessment. Training will be offered in English or French. After the intervention, participants and their partners will complete a semi-structured interview, seeking suggestions for improving the MSS, teaching curriculum, and intervention logistics.

Вмешательства

  • Поведенческое Memory Support System
    The MSS is a two-page-per-day, pocket-sized calendar/note-taking system with three sections: (a) events; (b) to do's; and (c) journaling for logging important things to be remembered (e.g., news about family/friends). MSS training consists of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after baseline assessment.

Первичные конечные точки

  • Interest in completion of MSS training [Срок оценки: From study start date up to 19 months.]
Вторичные конечные точки (8)
  • Adherence to French Memory Support System Intervention [Срок оценки: One week after starting the treatment (MSS intervention), at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]
  • Center for Epidemiologic Studies Depression Scale [Срок оценки: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]
  • Everyday Cognition questionnaire. [Срок оценки: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]
  • Functional Assessment Questionnaire [Срок оценки: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]
  • Quality of Life in Alzheimer Disease [Срок оценки: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]
  • State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project [Срок оценки: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]
  • Chronic Disease Self-efficacy Scale [Срок оценки: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]
  • Caregiver Burden Inventory Short-Form [Срок оценки: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]

Критерии участия

Критерии включения

  • diagnosis of single or multi-domain MCI
  • Clinical Dementia Rating global (CDR) score of ≤ 0.5
  • Montreal Cognitive Assessment score of ≥18
  • available contact with a care partner ≥ 2 times weekly
  • absence or stable intake of nootropic(s) for ≥ 3 months

Критерии исключения

  • visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training
  • concurrent participation in another related clinical trial

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
Поддерживающая терапия

Центры проведения

Канада · 1 центр
  • Bruyère Health Research Institute — Ottawa

Идентификаторы

NCT: NCT05999929 · M16-23-024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗