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Older AdultsNCT07079124

Social Participation Program for Older Adults in Nursing Homes

A study testing Multi-level Social Participation Intervention and Health Education in people with Older Adults, run by Fujian Medical University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Older Adults
What is being tested?
Multi-level Social Participation Intervention and Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
7 Jul 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Fujian Medical University

    Fuzhou, Fujian, 350122

Other trials in China

About this study

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

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?

Read more

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

Read the 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
Being tested
Multi-level Social Participation Intervention, Health Education
Keywords
older adults, social participation, nursing home, cognition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-level Social Participation InterventionBehavioural

    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 EducationBehavioural

    Standardized Health Education Materials

Study groups in NCT07079124
Study groupRoleWhat they receive
Social Participation InterventionExperimentalParticipants 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.
Receives: Behavioral: Multi-level Social Participation Intervention
Health EducationActive comparatorParticipants 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.
Receives: Behavioral: Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)

  1. 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).

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

  2. Loneliness

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

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

  3. 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)

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

  4. 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).

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

  5. Cost-benefit

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

    Measured: At the end of treatment at 12 weeks.

  6. Fidelity

    Intervention fidelity checklist

    Measured: At the end of treatment at 12 weeks.

  7. Compliance

    Attendance rate

    Measured: At the end of treatment at 12 weeks.

  8. 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).

    Measured: At the end of treatment at 12 weeks.

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

    Intervention-related adverse event record form

    Measured: At the end of treatment at 12 weeks.

  10. 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).

    Measured: At the end of treatment at 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start7 Jul 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07079124
Sponsor's protocol ID
2025[302]
Status last verified
Jul 2025
First submitted
1 Jul 2025
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multi-level Social Participation Intervention and Health Education in people with Older Adults, run by Fujian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in global cognitive function assessed by the Montreal Cognitive Assessment (MoCA) (time frame: From enrollment to the end of treatment at 12 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07079124.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.

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