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Идёт набор NCT06816797

Testing the Cog-Fun Aging Program for Older Adults With Subjective Cognitive Decline

Без фазы С лечением Subjective Cognitive Decline (SCD) Subjective Cognitive Impairment Subjective Memory Complaints

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: Cog Fun Ageing intervention, Cog-Fun Aging Crossover.
Кому может быть актуально
Состояния в реестре: Subjective Cognitive Decline (SCD), Subjective Cognitive Impairment, Subjective Memory Complaints. Базовые параметры: от 60 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
Израиль
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

Efficacy of the Cog-Fun Aging Health Promotion Intervention for Older Adults With Subjective Cognitive Decline: A Pilot Controlled Study

Обзор

The goal of this clinical trial is to learn if the Cog-Fun Aging program helps older adults with Subjective Cognitive Decline (SCD) manage memory challenges and improve their daily lives. The main questions it aims to answer are: * Does the program help participants better understand their cognitive challenges in daily life? * Do participants report using more effective strategies to manage their memory difficulties? * Does the Cog-Fun Aging program reduce negative emotions and self-perceptions related to SCD? Researchers will compare participants who complete the Cog-Fun Aging program with those who do not to determine the program's effectiveness. Participants will: Take part in a 10-week program with weekly sessions. Learn about SCD and how it affects daily life. Practice and monitor strategies to manage memory difficulties.

Вмешательства

  • Другое Cog Fun Ageing intervention
    Cog Fun Aging is a group-based intervention aimed at promoting positive occupational experiences despite cognitive challenges in day to day life. The intervention includes 10 weekly 120-minute group sessions led by experienced occupational therapists. Sessions incorporate learning about the bio-psycho-social factors of SCD and strategies to manage and cope with occupational challenges resulting from SCD.
  • Другое Cog-Fun Aging Crossover
    In the initial phase of the study (between T0 and T1) this group will receive "usual care". Participants are users of regional services where activities for healthy older adults are available. This group will continue going to activities as normal during the initial phase and then participate in the Cog-Fun Aging intervention.

Первичные конечные точки

  • Memory Impact Questionnaire (MIQ) [Срок оценки: After enrollment (before intervention) and 10 weeks later (after intervention)]
  • Multifactorial Memory Questionnaire-Short Version (MMQ-9) [Срок оценки: After enrollment (before intervention) and 10 weeks later (after intervention)]
  • Self-Regulation Skills Interview (SRSI) - adpated for study [Срок оценки: After enrollment (before intervention) and 10 weeks later (after intervention)]
  • SCD Awareness of Cognitive Difficulties in Daily Life Interview (SCD Interview) [Срок оценки: After enrollment (before intervention) and 10 weeks later (after intervention)]
Вторичные конечные точки (1)
  • Patient Health Questionnaire for Depression and Anxiety (PHQ-4) [Срок оценки: After enrollment (before intervention) and 10 weeks later (after intervention)]

Критерии участия

Критерии включения

  • experiencing memory changes and feeling concerned about them
  • a score of 23 or higher on the MoCA (Montreal Cognitive Assessment)
  • ability to speak and understand Hebrew sufficiently to participate in a Hebrew-speaking group

Критерии исключения

  • a self-reported health condition that significantly impacts functioning (e.g., uncontrolled diabetes, severe heart/lung disease)
  • residing in a medical institution or nursing home
  • currently participating in another SCD treatment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Израиль · 3 центра
  • Hebrew University of Jerusalem — Jerusalem
  • Merhavim Misgav — Misgav Regional Council
  • Hadarim College — Sde Warburg

Публикации

  • Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613. PMID 19996233
  • Ownsworth TL, McFarland KM, Young RM. Development and standardization of the Self-regulation Skills Interview (SRSI): a new clinical assessment tool for acquired brain injury. Clin Neuropsychol. 2000 Feb;14(1):76-92. doi: 10.1076/1385-4046(200002)14:1;1-8;FT076. PMID 10855062
  • Troyer AK, Shaikh KT, Baptist-Mohseni N, Singh A, Duncan-Kofman J, Vandermorris S, Rich JB. Creation and Validation of the MMQ-9: A Short Version of the Multifactorial Memory Questionnaire for Middle-Aged and Older Adults. Clin Gerontol. 2025 May-Jun;48(3):528-538. doi: 10.1080/07317115.2024.2421876. Epub 2024 Oct 29. PMID 39473141
  • Shaikh KT, Tatham EL, Parikh PK, McCreath GA, Rich JB, Troyer AK. Development and Psychometric Validation of a Questionnaire Assessing the Impact of Memory Changes in Older Adults. Gerontologist. 2019 Jul 16;59(4):e248-e257. doi: 10.1093/geront/gny011. PMID 29522122

Идентификаторы

NCT: NCT06816797 · 20112024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗