Social Participation Program for Older Adults in Nursing Homes
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: Multi-level Social Participation Intervention, Health Education.
- Кому может быть актуально
- Состояния в реестре: Older Adults. 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
- Китай
- 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
A Multilevel Social Participation Intervention for Older Adults in Nursing Homes: Development and Implementation Based on the Social Ecological Model
Обзор
The goal of this clinical trial is to learn whether a multi-level social participation program can help improve social engagement and slow down cognitive decline in older adults living in nursing homes. The main questions it aims to answer are: Can this program improve how often and how meaningfully participants engage in social activities? Can this program help maintain or improve participants' cognitive abilities? Researchers will compare this program to a health education group to see if it is more effective in supporting social participation and cognitive health. Participants will: Join a 12-week program that includes group activities, personalized support, staff assistance, and health education content Be assessed before and after the program using cognitive and social participation questionnaires Be randomly assigned to either the multi-level social participation program group or the health education group
Подробное описание
This study aims to evaluate the feasibility and effectiveness of a multi-level social participation intervention among older adults residing in nursing homes, based on the Social Ecological Model (SEM). Against the backdrop of accelerated aging and rising dementia prevalence in institutional settings, the intervention seeks to enhance social engagement and mitigate cognitive decline through a structured, multi-dimensional approach.
A total of 120 older adults aged 60 years and above will be recruited from nursing homes and randomly assigned to either the intervention group or a health education group. The intervention will span 12 weeks and comprises five core components:
1. a health education manual, 2. a resource information package, 3. a structured library of social activities, 4. a motivational incentive kit, and 5. a training toolkit for staff.
The intervention addresses three levels of influence:
1. Individual level: enhancing motivation and cognitive engagement through behavior activation strategies; 2. Interpersonal level: fostering peer interaction and support networks; 3. Organizational level: enabling supportive environments through staff training and institutional support.
Assessments will be conducted at baseline and post-intervention. The health education group will receive standardized health education materials during the study. This trial will provide empirical evidence for a scalable model of dementia prevention through social participation in institutional settings.
Вмешательства
- Поведенческое Multi-level Social Participation Intervention
The intervention will span 12 weeks and comprises five core components: (1) a health education manual, (2) a resource information package, (3) a structured library of social activities, (4) a motivational incentive kit, and (5) a training toolkit for staff. - Поведенческое Health Education
Standardized Health Education Materials
Первичные конечные точки
- Change in global cognitive function assessed by the Montreal Cognitive Assessment (MoCA) [Срок оценки: From enrollment to the end of treatment at 12 weeks.]
Вторичные конечные точки (10)
- Social participation [Срок оценки: At baseline and the end of treatment at 12 weeks.]
- Loneliness [Срок оценки: At baseline and the end of treatment at 12 weeks.]
- Change in health-related quality of life (HRQoL) assessed by EQ-5D-5L [Срок оценки: From enrollment to the end of treatment at 12 weeks.]
- Psychological state [Срок оценки: At baseline and the end of treatment at 12 weeks.]
- Cost-benefit [Срок оценки: At the end of treatment at 12 weeks.]
- Fidelity [Срок оценки: At the end of treatment at 12 weeks.]
- Compliance [Срок оценки: At the end of treatment at 12 weeks.]
- Intervention satisfaction with intervention measured by 5-point Likert scale [Срок оценки: At the end of treatment at 12 weeks.]
- Incidence of intervention-related adverse events (AEs) recorded by Self-compiled questionnaire [Срок оценки: At the end of treatment at 12 weeks.]
- Intervention acceptability [Срок оценки: At the end of treatment at 12 weeks.]
Критерии участия
Критерии включения
- Age 60 years or older
- Basic comprehension and verbal communication abilities
- Resided in a long-term care facility for at least one month
Критерии исключения
- Clinically diagnosed with dementia (based on DSM-IV-R criteria)
- Presence of severe physical illness or psychiatric disorder
- Significant visual or hearing impairments that may interfere with accurate cognitive assessment
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
- Простое слепое
- Основная цель
- Организация здравоохранения
Центры проведения
Китай · 1 центр
- Fujian Medical University — Фучжоу
Идентификаторы
NCT: NCT07079124 · 2025[302]