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Clinical Trials in Italy / NCT07443813
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An Innovative App-based Intervention to Promote Social Connectedness and Well-being in Older Adults

NCT07443813 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-11-22
Last updated
2026-03-19

Condition(s) studied

Social Isolation in Older AdultsLoneliness

Investigational drug(s) / intervention(s)

Blended VITA intervention (hybrid app-based and in-person social engagement program)

Blended VITA intervention (hybrid app-based and in-person social engagement program): Participants in this arm receive a 4-month blended intervention combining structured in-person sessions with guided use of the VITA mobile application. In-person sessions provide digital literacy training to support app navigation, safe interaction, and identification of relevant community opportunities. Through the app, participants can discover local social events, group activities, and community resources, as well as create and share social initiatives with other treatment group members. The research team provides ongoing in-person and remote support, facilitating connections among nearby participants with shared interests. The program promotes digital competence, community participation, peer networking, and social inclusion. Engagement (e.g., app use and activity participation) is monitored, and outcomes related to social connectedness, well-being, and community engagement are assessed at baseline, post-intervention (4 months), and 2-month follow-up.

Study summary

This study evaluates the impact of a group-based intervention designed to promote social connectedness and enhance psychological well-being among older adults. The intervention lasts four months and is supported by a dedicated mobile application that helps participants discover local social activities, connect with peers who share similar interests, and stay informed about community events, with the aim of supporting (not replacing) in-person interactions. This randomized controlled trial assigns participants either to a treatment group, which receives digital literacy training, access to the app, and structured support from the research team to facilitate social engagement within their local community, or to a waitlist control group, which receives access to the app only after the study period. Assessments are conducted at baseline, post-intervention (4 months), and at a 2-month follow-up. The study evaluates changes in social connectedness, loneliness, psychological well-being, and technology use, using a mixed-methods approach combining self-report questionnaires, app-usage data, and qualitative feedback.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Age 65 years or older at the time of enrollment. * Living independently in the community (not in long-term care facilities or nursing homes). * Provision of written informed consent. Exclusion Criteria: * Diagnosis of severe psychiatric disorders * Significant cognitive or physical impairment that prevents comprehension of study procedures or use of the mobile application. * Residence in assisted-living facilities, nursing homes, or other long-term care institutions.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Università degli Studi di Padova Padova PD

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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 NCT07443813 on ClinicalTrials.gov ↗ ← All trials in Italy