Social Participation and Healthy Aging

NCT06162871 | Active Not Recruiting

• 1 other identifier: NP.2023/2534
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Aging

Keywords

healthy aging; Generational exchange; Psychosocial intervention; Pilot study

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (2)

active participation

EXPERIMENTAL

Behavioral: Presentations and interactive debate sessions, with intergenerational exchange

non involved in active part

NO INTERVENTION

Interventions

Presentations and interactive debate sessions, with intergenerational exchange BEHAVIORAL

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.

active participation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• people who are 65 years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cagliari: lead
• Fondazione Sardegna: collaborator

Study Sites (1)

San Giovanni di Dio Hospital

Cagliari, CA, 09100, Italy

Location

Related Publications (1)

• Cossu G, Lorrai S, Galetti A, Perra A, Tusconi M, Carra G, Preti A, Holzinger A, Carta MG. Promoting healthy aging through intergenerational exchange and digital empowerment: a pilot randomized controlled trial. Front Psychiatry. 2025 Jul 16;16:1637181. doi: 10.3389/fpsyt.2025.1637181. eCollection 2025.

  PMID: 40740264 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The experimental condition in the experimental group consists of a psychosocial intervention. The control group is initially inactive and after the experimental group post treatment will be involved in the experimental intervention

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: December 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)