Clinical trial NCT06162871: Social Participation and Healthy Aging
Official title: The Effect of Social Participation As a Key Determinant of Healthy Aging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Aging
Keywords: healthy aging
Generational exchange
Psychosocial intervention
Pilot study
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: Fondazione Sardegna
First posted: 2023-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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 outcomes:
measure: Change from Baseline to post treatment and to follow-up of The Short Form Health Survey (Quality of life)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
measure: Change from Baseline to post treatment and to follow-up of The Brief Social Rhythms Scale (Social and biological Rhythms)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
measure: Change from Baseline to post treatment and to follow-up of Patient Health Questionnaire-9 (Depression symptoms)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
measure: Change from Baseline to post treatment and to follow-up of Physical Activity Questionnaire (type and quantity of physical activity)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
measure: Change from Baseline to post treatment and to follow-up of Addenbrooke's Cognitive Examination (Cognitive performance)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
measure: Evaluation of the Feasibility of the intervention with Dropout rate at post intervention time
timeFrame: at T1 (12 weeks)
measure: Intervention satisfaction at post intervention time
timeFrame: at T1 (12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: San Giovanni di Dio Hospital
state: CA
Study officials:
References: