Non-pharmacological Interventions for People With Mild Cognitive Impairment in the Community

Официальное название

Development of a 'Community-Family Mutual Support' Intervention Model for Patients With Mild Cognitive Impairment Based on Social Support Theory

Обзор

Mild cognitive impairment (MCI) may increase the risk of dementia. This study will evaluate an 8-week community-family mutual support intervention for adults aged 60 years or older with MCI. Participants will be randomly assigned to an intervention group or a control group. The control group will receive routine community care, while the intervention group will additionally receive cognitive training, health education, family support, mutual support activities, and individualized feedback. Cognitive function, daily functioning, emotional status, and social support will be assessed before and after the intervention.

Вмешательства

• Другое Community-Family Mutual Support Intervention
  Participants will receive an 8-week community-family mutual support intervention in addition to routine community care. Guided by social support theory, the program integrates informational, emotional, instrumental, and appraisal support. It includes MCI-related health education, cognitive training, physical activity guidance, emotional self-monitoring, home-based practice with family assistance, mutual support between paired families, group activities, and individualized feedback. The intervent
• Другое Routine Community Care
  Participants will receive routine community care, including standard health education and usual community-based health services, during the 8-week study period. They will not receive the community-family mutual support intervention.

Первичные конечные точки

• Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA) [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (2)

• Change From Baseline in Social Support Rating Scale (SSRS) Total Score [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• Aged 60 years or older.
• Meets the diagnostic criteria for mild cognitive impairment, including subjective cognitive decline, objective impairment in at least one cognitive domain, relatively preserved activities of daily living, and no diagnosis of dementia.
• Has lived in the study community for at least 6 months.
• Has completed primary school or above and is able to read and write.
• Is able to communicate and complete the study assessments and intervention activities.
• Voluntarily participates and provides written informed consent.

Критерии исключения

• Unable to communicate effectively.
• Has severe visual or hearing impairment that prevents participation.
• Has dementia, schizophrenia, or another severe psychiatric disorder.
• Has a serious or unstable physical illness that prevents participation in the intervention.
• Is currently participating in another cognitive training or similar intervention study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07703267 · 81251000 · 81251000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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