Social Participation and Healthy Aging

The Effect of Social Participation As a Key Determinant of Healthy Aging

The research aims to promote active aging through a pilot study. The design will be crossover with two groups. Intervention will consist of presentations and interactive debate sessions, with a central focus on intergenerational exchange covering cultural, historical, and health-related topics. A key aspect is the active involvement of beneficiaries, individuals over sixty-five. The outcomes will be quality of life, presence of depressive symptoms, and regularity of biological and social rhythms.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Aging
• Intervention / Treatment: Behavioral: Presentations and interactive debate sessions, with intergenerational exchange

Detailed Description

In 2050, 36% of the Italian population will be over 65 years old. The European Union has identified as a priority the increase in research on active aging, promoting activities that can maintain and enhance the health and social engagement of individuals aged 65 and above.

This pilot study aims to assess feasibility a preliminary measure of effectiveness of a psychosocial intervention focused on intergenerational exchange on quality of life, biological and social rhythms, and mood in a group of elderly

The outcomes will include quality of life, presence of depressive symptoms, and regularity of biological and social rhythms, assessed before the intervention, immediately after intervention and at a follow-up four months after the intervention's conclusion.

The psychosocial intervention will consist of sessions on a weekly basis and delivered both in-person and remotely. The sessions will include presentations and interactive debate sessions, with a central focus on intergenerational exchange covering cultural, historical, and health-related topics. A key aspect is the active involvement of beneficiaries, individuals over sixty-five, who will be asked to prepare presentations with the support of project-provided facilitators. Simultaneously, the project will promote social inclusion, enhance skills, organizational capabilities, and computer literacy.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • CA
    • Cagliari, CA, Italy, 09100
      • San Giovanni di Dio Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• people who are 65 years of age or older

Exclusion Criteria:

• have serious problems with independent walking,
• have serious neurological conditions or serious disabilities that make it impossible to participate in the intervention in person or remotely

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active participation	Behavioral: Presentations and interactive debate sessions, with intergenerational exchange; Intervention will consist of 12 sessions, each lasting about two hours, conducted on a weekly basis and delivered both in-person and remotely. The sessions will include presentations and interactive debate sessions, with a central focus on intergenerational exchange covering cultural, historical, and health-related topics. A key aspect is the active involvement of beneficiaries, individuals over sixty-five, who will be asked to prepare presentations with the support of project-provided facilitators. Simultaneously, the project will promote and enhance skills, organizational capabilities, and computer literacy.
No Intervention: non involved in active part

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to post treatment and to follow-up of The Short Form Health Survey (Quality of life)	To evaluate it will be used: The Short Form Health Survey (SF-12), a brief version of SF-36 questionnaire, made up of twelve questions, values range from 12 to 47, includes the following dimensions: physical activity, disturbance in physical health, physical condition, self-assessment of health status, vitality, social activity and mental health assessed on a monthly basis . Higher scores recorded a greeting and better Quality of life	T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
Change from Baseline to post treatment and to follow-up of The Brief Social Rhythms Scale (Social and biological Rhythms)	To evaluate it will be used: The Brief Social Rhythms Scale (BSRS), a 10 item questionnaire, values range from 10 to 60, designed to assess the level of regularity in biological and social rhythms, specifically those related to sleep-wake cycles and appetite, as well as social contacts. Higher scores recorded a worse regulation of rhythms	T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
Change from Baseline to post treatment and to follow-up of Patient Health Questionnaire-9 (Depression symptoms)	To evaluate it will be used: Patient Health Questionnaire-9 (PHQ-9) a short self-administered tool, values range from 0 to 27, used for screening, diagnosis, monitoring and measuring the severity of depression. It's composed of 9 items that correspond to the symptoms of major depression according to DSM-IV on last two weeks. Higher scores identify a greater presence of depressive symptoms.	T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
Change from Baseline to post treatment and to follow-up of Physical Activity Questionnaire (type and quantity of physical activity)	To evaluate it will be used: Physical Activity Questionnaire (IPAQ) designed to measure the type and quantity of physical activity undertaken in the past 7 days, values range from 0 to the maximum amount of minutes a person spends on physical activity or sedentary activities, including occupational and recreational physical activities, through 9 items, on a weekly basis, Higher scores identify in a subscale a frequent physical activity (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.	T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
Change from Baseline to post treatment and to follow-up of Addenbrooke's Cognitive Examination (Cognitive performance)	To evaluate it will be used: Addenbrooke's Cognitive Examination (ACE-R), a brief cognitive test, values range from 0 to 100, that assesses five cognitive areas: attention/orientation, memory, verbal fluency, language, and visuo-spatial abilities. The test incorporates the Mini Mental State Examination (MMSE). The higher the score obtained in the test, the lower the presence of signs that identify cognitive deterioration on the screening performance scales	T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
Evaluation of the Feasibility of the intervention with Dropout rate at post intervention time	To evaluate it will be used: Dropout rate (25% dropout in the sample will be considered acceptable considering that it is a group of elderly people)	at T1 (12 weeks)
Intervention satisfaction at post intervention time	Intervention satisfaction questionnaire (it will be considered a satisfactory level if on average the intervention is rated by the participants one standard deviation above the average of the ad hoc questionnaire)	at T1 (12 weeks)

Collaborators and Investigators

• Sponsor: University of Cagliari
• Collaborators: Fondazione Sardegna

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Pilot study; Psychosocial intervention; healthy aging; Generational exchange
• Other Study ID Numbers: NP.2023/2534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No