Social Participation Program for Older Adults in Nursing Homes

NCT07079124 | Enrolling By Invitation DMC

• 1 other identifier: 2025[302]
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Older Adults

Keywords

older adults; social participation; nursing home; cognition

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (10)

• 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.

Study Arms (2)

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.

Behavioral: Multi-level Social Participation Intervention

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.

Behavioral: Health Education

Interventions

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.

Social Participation Intervention

Health Education BEHAVIORAL

Standardized Health Education Materials

Health Education

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University

Fuzhou, Fujian, 350122, China

Location

Study Officials

• Hong Li

  Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 22, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)