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: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
120
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.
Standardized Health Education Materials
Fujian Medical University
Fuzhou, Fujian, China
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.
Time frame: From enrollment to the end of treatment at 12 weeks.
Social participation
Social participation will be measured through four instruments: 1. The Social Support Rating Scale (SSRS) (12-66 points; higher scores indicate better social support); 2. Lubben Social Network Scale-6 (LSNS-6) (0-30 points; higher scores indicate stronger social networks); 3. Community Participation Index (CPI) (0-113 points; higher scores indicate more frequent social engagement); 4. The interRAI LTCF Social Participation Index (0-6 points; higher scores indicate greater social involvement).
Time frame: 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).
Time frame: 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)
Time frame: From enrollment to the end of treatment at 12 weeks.
Psychological state
1. Geriatric Depression Scale-15 (GDS-15) (0-15 points; higher scores indicate more severe depression); 2. Self-Rating Anxiety Scale (SAS) (25-100 standard score; higher scores indicate more severe anxiety).
Time frame: 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.
Time frame: At the end of treatment at 12 weeks.
Fidelity
Intervention fidelity checklist
Time frame: At the end of treatment at 12 weeks.
Compliance
Attendance rate
Time frame: 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).
Time frame: 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
Time frame: 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).
Time frame: At the end of treatment at 12 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.