Social Participation Program for Older Adults in Nursing Homes

NCT ID: NCT07079124

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2026-06-30

Brief Summary

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

Detailed Description

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.

Conditions

Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multi-level Social Participation Intervention

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: BEHAVIORAL

Standardized Health Education Materials

Interventions

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.

Intervention Type: BEHAVIORAL

Health Education

Standardized Health Education Materials

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 60 years or older
• Basic comprehension and verbal communication abilities
• Resided in a long-term care facility for at least one month

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Huang Chenshan

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Li

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University

Locations

Fujian Medical University

Fuzhou, Fujian, China

Countries

China

Other Identifiers

2025[302]

Identifier Type: -

Identifier Source: org_study_id