A Multilevel Social Participation Intervention for Older Adults in Nursing Homes: Development and Implementation Based on the Social Ecological Model
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in global cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
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
详细描述
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:
- a health education manual,
- a resource information package,
- a structured library of social activities,
- a motivational incentive kit, and
- a training toolkit for staff.
The intervention addresses three levels of influence:
- Individual level: enhancing motivation and cognitive engagement through behavior activation strategies;
- Interpersonal level: fostering peer interaction and support networks;
- Organizational level: enabling supportive environments through staff training and institutional support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60 years or older
- •Basic comprehension and verbal communication abilities
- •Resided in a long-term care facility for at least one month
排除标准
- •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
研究组 & 干预措施
Social Participation Intervention
Participants in this group will receive a 12-week multi-level social participation intervention based on the Social Ecological Model. The intervention includes individual-level goal setting, interpersonal-level group activities, and organizational-level environmental support. Intervention components consist of a health education manual, activity and social resource toolkit, motivational participation package, and staff training sessions. Activities are conducted twice per week.
干预措施: Multi-level Social Participation Intervention (Behavioral)
Health Education
Participants in the health education group will receive standardized health education materials during the 12-week study period, without participating in the structured multi-level social participation intervention. After study completion, they will be offered the opportunity to join the full intervention program if they wish.
干预措施: Health Education (Behavioral)
结局指标
主要结局
Change in global cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
时间窗: From enrollment to the end of treatment at 12 weeks.
The Montreal Cognitive Assessment (MoCA) will be used to assess global cognitive function, including attention, memory, language, visuospatial skills, and executive functions, with scores ranging from 0 to 30, where higher scores indicate better cognitive performance.
Change in global cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
时间窗: From enrollment to the end of treatment at 12 weeks.
The Montreal Cognitive Assessment (MoCA) will be used to assess global cognitive function, including attention, memory, language, visuospatial skills, and executive functions, with scores ranging from 0 to 30, where higher scores indicate better cognitive performance.
次要结局
- Fidelity(At the end of treatment at 12 weeks.)
- Compliance(At the end of treatment at 12 weeks.)
- Cost-benefit(At the end of treatment at 12 weeks.)
- Intervention acceptability(At the end of treatment at 12 weeks.)
- Social participation(At baseline and the end of treatment at 12 weeks.)
- Loneliness(At baseline and the end of treatment at 12 weeks.)
- Change in health-related quality of life (HRQoL) assessed by EQ-5D-5L(From enrollment to the end of treatment at 12 weeks.)
- Psychological state(At baseline and the end of treatment at 12 weeks.)
- Intervention satisfaction with intervention measured by 5-point Likert scale(At the end of treatment at 12 weeks.)
- Incidence of intervention-related adverse events (AEs) recorded by Self-compiled questionnaire(At the end of treatment at 12 weeks.)
- Fidelity(At the end of treatment at 12 weeks.)
- Compliance(At the end of treatment at 12 weeks.)
- Social participation(At baseline and the end of treatment at 12 weeks.)
- Loneliness(At baseline and the end of treatment at 12 weeks.)
- Change in health-related quality of life (HRQoL) assessed by EQ-5D-5L(From enrollment to the end of treatment at 12 weeks.)
- Psychological state(At baseline and the end of treatment at 12 weeks.)
- Cost-benefit(At the end of treatment at 12 weeks.)
- Intervention satisfaction with intervention measured by 5-point Likert scale(At the end of treatment at 12 weeks.)
- Incidence of intervention-related adverse events (AEs) recorded by Self-compiled questionnaire(At the end of treatment at 12 weeks.)
- Intervention acceptability(At the end of treatment at 12 weeks.)
研究者
Huang Chenshan
MD
Fujian Medical University