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NCT Number: NCT07079124

Social Participation Program for Older Adults in Nursing Homes

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

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Key information

Conditions

Older Adults

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Medical University

Fuzhou, Fujian, 350122, China

About this study

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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Health Education

Behavioral

Standardized Health Education Materials

Primary outcomes

  1. Change in global cognitive function assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

Secondary outcomes

  1. Social participation

    Time frame: At baseline and the end of treatment at 12 weeks.

    Social participation will be measured through four instruments:

    • The Social Support Rating Scale (SSRS) (12-66 points; higher scores indicate better social support);
    • Lubben Social Network Scale-6 (LSNS-6) (0-30 points; higher scores indicate stronger social networks);
    • Community Participation Index (CPI) (0-113 points; higher scores indicate more frequent social engagement);
    • The interRAI LTCF Social Participation Index (0-6 points; higher scores indicate greater social involvement).

  2. Loneliness

    Time frame: At baseline and the end of treatment at 12 weeks.

    The 8-item UCLA Loneliness Scale (ULS-8) will be used (8-32 points; higher scores indicate greater loneliness).

  3. Change in health-related quality of life (HRQoL) assessed by EQ-5D-5L

    Time frame: From enrollment to the end of treatment at 12 weeks.

    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)

  4. Psychological state

    Time frame: At baseline and the end of treatment at 12 weeks.

    • Geriatric Depression Scale-15 (GDS-15) (0-15 points; higher scores indicate more severe depression);
    • Self-Rating Anxiety Scale (SAS) (25-100 standard score; higher scores indicate more severe anxiety).

  5. Cost-benefit

    Time frame: At the end of treatment at 12 weeks.

    The EQ-5D-5L questionnaire will be used to calculate quality-adjusted life years for cost-effectiveness analysis.

  6. Fidelity

    Time frame: At the end of treatment at 12 weeks.

    Intervention fidelity checklist

  7. Compliance

    Time frame: At the end of treatment at 12 weeks.

    Attendance rate

  8. Intervention satisfaction with intervention measured by 5-point Likert scale

    Time frame: At the end of treatment at 12 weeks.

    The Intervention Satisfaction Evaluation Questionnaire (self-developed) will be used (9-45 points; higher scores indicate greater satisfaction with the intervention).

  9. Incidence of intervention-related adverse events (AEs) recorded by Self-compiled questionnaire

    Time frame: At the end of treatment at 12 weeks.

    Intervention-related adverse event record form

  10. Intervention acceptability

    Time frame: At the end of treatment at 12 weeks.

    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).

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

A Multilevel Social Participation Intervention for Older Adults in Nursing Homes: Development and Implementation Based on the Social Ecological Model

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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