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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
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:
The intervention addresses three levels of influence:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Participation Intervention | Experimental | 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. |
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| Health Education | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-level Social Participation Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in global cognitive function assessed by the Montreal Cognitive Assessment (MoCA) | 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. | From enrollment to the end of treatment at 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Social participation | Social participation will be measured through four instruments:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Li | Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University | Fuzhou | Fujian | 350122 | China |
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| Health Education | Behavioral | Standardized Health Education Materials |
|
| At baseline and the end of treatment at 12 weeks. |
| Loneliness | The 8-item UCLA Loneliness Scale (ULS-8) will be used (8-32 points; higher scores indicate greater loneliness). | At baseline and the end of treatment at 12 weeks. |
| Change in health-related quality of life (HRQoL) assessed by EQ-5D-5L | The EQ-5D-5L will be used, including: Utility index (higher scores indicate better health); Visual analog scale (0-100; higher scores indicate better health) | From enrollment to the end of treatment at 12 weeks. |
| Psychological state |
| At baseline and the end of treatment at 12 weeks. |
| Cost-benefit | The EQ-5D-5L questionnaire will be used to calculate quality-adjusted life years for cost-effectiveness analysis. | At the end of treatment at 12 weeks. |
| Fidelity | Intervention fidelity checklist | At the end of treatment at 12 weeks. |
| Compliance | Attendance rate | At the end of treatment at 12 weeks. |
| Intervention satisfaction with intervention measured by 5-point Likert scale | The Intervention Satisfaction Evaluation Questionnaire (self-developed) will be used (9-45 points; higher scores indicate greater satisfaction with the intervention). | At the end of treatment at 12 weeks. |
| Incidence of intervention-related adverse events (AEs) recorded by Self-compiled questionnaire | Intervention-related adverse event record form | At the end of treatment at 12 weeks. |
| Intervention acceptability | The Intervention Acceptability Assessment Scale (based on the Theory of Acceptance and Use of Technology framework) will be used (8-40 points; higher scores indicate greater acceptability of the intervention). | At the end of treatment at 12 weeks. |