Ireland
--:--IST
Active, not recruiting Not applicable

Social Participation and Healthy Aging

NCT06162871 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2023-12-01
Last updated
2025-02-11

Condition(s) studied

Healthy Aging

Investigational drug(s) / intervention(s)

Presentations and interactive debate sessions, with intergenerational exchange

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Change from Baseline to post treatment and to follow-up of The Short Form Health Survey (Quality of life) — T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
    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
  • Change from Baseline to post treatment and to follow-up of The Brief Social Rhythms Scale (Social and biological Rhythms) — T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
    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
  • Change from Baseline to post treatment and to follow-up of Patient Health Questionnaire-9 (Depression symptoms) — T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
    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.
  • Change from Baseline to post treatment and to follow-up of Physical Activity Questionnaire (type and quantity of physical activity) — T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
    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.
  • Change from Baseline to post treatment and to follow-up of Addenbrooke's Cognitive Examination (Cognitive performance) — T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
    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
  • Evaluation of the Feasibility of the intervention with Dropout rate at post intervention time — at T1 (12 weeks)
    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)
  • Intervention satisfaction at post intervention time — at T1 (12 weeks)
    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)

Trial sites (1)

FacilityCityRegionStatus
San Giovanni di Dio Hospital Cagliari CA
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06162871 on ClinicalTrials.gov ↗ ← All trials in Italy