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Набор скоро начнётся NCT07099040

Community-based Multi-domain Intervention to Detect and Delay Cognitive Decline in Community-dwelling Older Adults: A Pilot Study

Без фазы С лечением Mild Cognitive Impairment Mild Cognitive Impairment (MCI)

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: Social support, Health coaching, Physical Activity, Cognitive activity.
Кому может быть актуально
Состояния в реестре: Mild Cognitive Impairment, Mild Cognitive Impairment (MCI). 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

IMPlementation stRategiEs for Scalability and Sustainability - Multidomain INterventions in a Structured Care Pathway to Detect and Delay Cognitive Decline in Community-dwelling Older Adults (IMPRESS-MIND2S): Pilot Test

Обзор

The incidence of cognitive impairment and its burden are increasing with a rapidly ageing population. In Singapore, the prevalence of dementia among older adults aged 60 and above is approximately 10%, which will translate to approximately 152,000 older adults living with dementia by the year 2030. Using 2013 data as estimates, the total annual cost of dementia was already estimated at S$532 million while cost per person was estimated at S$10,245 per annum, and a further increase in corresponding costs is expected through 2030 with the projection of increase in persons with dementia (PWDs). There is thus an urgent need for (i) effective, scalable, and sustainable interventions that are widely accessible to detect and delay cognitive decline and frailty in our community-dwelling older adults, and (ii) providing support for their caregivers. This study aims to test the feasibility of a community-based multi-domain intervention for detecting and delaying cognitive impairment for the older population.

Вмешательства

  • Поведенческое Social support
    Psychoeducation will be provided for enrolled participants and their caregivers by Community Resource, Engagement \& Support Team (CREST). Visits from CREST teams will be provided on an ad hoc basis, based on older adult participants' needs and circumstances.
  • Поведенческое Health coaching
    Health coaching aims to control risk factors of dementia by community nurses (CMNs) and wellbeing coordinators (WBCs). These include addressing chronic conditions and lifestyle aspects (diet, exercise, habits stress management, and sleep). Care recipients are encouraged to proactively manage their health journey and establish Specific, Measurable, Achievable, Relevant, and Time-bound (SMART) goals with the support of WBCs and CMNs. This multi-faceted approach has the potential to not only addres
  • Поведенческое Physical Activity
    Physical Activity that focuses on improving resistance and balance for care recipients. Physical activity will be conducted 2 times/week at the Active Ageing Centres (AACs) with care recipients for a duration of 1-hour and 1-2 times/week at home.
  • Поведенческое Cognitive activity
    Cognitive activity will be delivered to enrolled care recipients by Community Resource, Engagement \& Support Team (CREST) and AAC staff. With the incorporation of using SilverPad as part of the cognitive activities, care recipients will undergo 1-hour weekly cognitive activity. Youth volunteers will also be engaged to help facilitate the sessions. This will be augmented with additional 1-2 times weekly home-based training sessions supervised by caregivers.

Первичные конечные точки

  • Care recipients' cognition measured by the Montreal Cognitive Assessment (MoCA) [Срок оценки: From enrollment to the end of month 6]
Вторичные конечные точки (12)
  • Care recipients' physical function measured by short physical performance battery (SPPB) [Срок оценки: From enrollment to the end of month 6]
  • Care recipients' frailty measured by FRAIL scale [Срок оценки: From enrollment to the end of month 6]
  • Care recipients' health-related quality of life measured by EuroQol 5-Dimension 5-Level (EQ-5D-5L) [Срок оценки: From enrollment to the end of month 6]
  • Care recipients' health state on a EuroQol Visual Analogue Scale (EQ VAS) [Срок оценки: From enrollment to the end of month 6]
  • Caregivers' caregiving burden measured by Zarit burden interview (ZBI) [Срок оценки: From enrollment to the end of month 6]
  • Care recipients' ability to perform more complex tasks necessary for independent living within the community - Measured by Lawton scale iADL [Срок оценки: From enrollment to the end of month 6]
  • Feasibility outcome - Acceptability, collected from the Acceptability of Intervention Measure (AIM) [Срок оценки: At the end of months 2, 4, and 6]
  • Feasibility outcome - Perceived appropriateness, collected from the Intervention Appropriateness Measure (IAM) [Срок оценки: At the end of months 2, 4, and 6]
  • Feasibility outcome - Perceived feasibility, collected from the Feasibility of Intervention Measure (FIM) [Срок оценки: At the end of months 2, 4, and 6]
  • Feasibility outcome - Care recipients' perceptions of the intervention, collected from qualitative interview [Срок оценки: Month 6]
  • Feasibility outcome - Acceptability, collected from the Acceptability of Intervention Measure (AIM) [Срок оценки: Month 6]
  • Feasibility outcome - Perceived appropriateness, collected from the Intervention Appropriateness Measure (IAM) [Срок оценки: Month 6]

Критерии участия

Критерии включения

Older Adults:

  • 60 years and older with cognitive concerns or (self-reported or observer reported),
  • English and/or Mandarin speaking,
  • no physical disabilities that preclude study participation,
  • willing to complete all study-related activities,
  • no known diagnosis of major cognitive impairment,
  • able to provide consent.

Caregivers:

  • 21 years and older,
  • English and/or Mandarin speaking,
  • able to provide consent
  • have at least 6-month experience of taking care of older adults with mild cognitive impairment.

Service providers:

  • 21 years and older,
  • English and/or Mandarin speaking,
  • able to provide consent.

Youth Volunteers:

  • volunteers from Youth Corps Singapore (YCS)
  • English and/or Mandarin speaking,
  • able to provide assent

Критерии исключения

Older adults

  • Known diagnosis of moderate dementia and above,
  • Montreal Cognitive Assessment (MoCA) score <18,
  • Has difficulty in basic activities of daily living,
  • disorders that affects safe engagement in the intervention (e.g. symptomatic cardiovascular disease, revascularization within 1 year, major depression or anxiety with ongoing treatment, underlying malignancy),
  • Severe vision or hearing impairment or any other disorders preventing cooperation as judged by the study team,
  • Major illness with life expectancy <6 months,
  • Institutionalized,
  • Planned major surgery within the duration of the multi-domain intervention,
  • Physical disabilities that preclude study participation.

Caregivers:

  • aged below 21 years old,
  • not being the primary family caregiver of at least one older individual,
  • not being able to read, write, and converse in English/Mandarin,
  • their family members (older adults) have not participated in the pilot test for at least one month (1 session of cognitive activity/week, 2 sessions of physical activity/week).

Care providers:

  • not working for the older population,
  • Not being able to read, write, and converse in English/Mandarin,
  • have not provided service during the period of the pilot test for at least one month (1 session of cognitive activity/week, 2 sessions of physical activity/week).

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07099040 · 202503-0001 · NICTran2023-0014

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗