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Active Not RecruitingNCT07443813

An Innovative App-based Intervention to Promote Social Connectedness and Well-being in Older Adults

Virtual, Inclusive, Together, Active (VITA): An Innovative App-based Intervention to Promote Social Connectedness and Well-being in Older Adults

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
University of Padova · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Accepted

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.

Detailed description

Rationale: The study is a randomized controlled trial designed to evaluate the effectiveness of a digitally supported, community-based intervention aimed at promoting social connectedness and reducing loneliness and social isolation among older adults, addressing a growing public health concern in ageing populations worldwide. As literature highlights, as individuals move into later life, they often experience a series of life transitions and changes - such as retirement, bereavement, declining physical health, and changes in living arrangements; that can progressively limit opportunities for social interaction and participation in community life. These changes can weaken existing relationships and reduce the formation of new social ties, leading to decreased social engagement and an increased risk of loneliness. Older age is therefore often associated with an increased risk of social isolation due to retirement, loss of social roles, reduced mobility, and shrinking social networks. Moreover, social isolation and loneliness in later life have been consistently linked to poorer mental and physical health outcomes, including depression, cognitive decline, and reduced quality of life. At the same time, older adults often face barriers to accessing digital tools that could support social participation, such as limited digital literacy and low confidence in the use of technology. The study therefore seeks to address these challenges by combining digital literacy training, access to a user-friendly mobile application, and structured support for in-person social engagement. Study design and outcome measures: The study begins with a baseline assessment (T0), when participants complete a battery of questionnaires collecting demographic information (e.g., age, gender, education level, living situation) and baseline data on psychosocial well-being and technology use. Measures include self-report instruments assessing: * Demographic information - 10 questions * Health status questions - 9 questions * Psychological Well-Being Scale (PWB)- 18 items. * Generalized Anxiety Disorder (GAD)-7 - 7 items. * Geriatric Depression Scale (GDS)- 5- 5 items. * Social life questions - 4 questions * University of California, Los Angeles (UCLA) Loneliness Scale 3 - 3 items. * Multidimensional Scale of Perceived Social Support (MSPSS) - 12 items. * Technology use questions - 4 questions Participants complete the same questionnaire at three time points: Baseline (T0), Post-intervention, at 4 months (T1), Follow-up, 2 months after the intervention (T2). App usage data (e.g., number of logins, time spent on the app, activities joined or created, and interactions with other users) are continuously collected for participants in the intervention group to assess levels of engagement and explore potential mechanisms of change. In addition, qualitative interviews are conducted at post-intervention and follow-up to gain deeper insight into participants' experiences, perceived benefits and challenges, and the ways in which the intervention may have influenced their social lives. The mixed-methods approach is used to comprehensively evaluate the effectiveness, feasibility, and acceptability of the intervention. Intervention description: Following baseline assessment, eligible participants are randomly assigned to one of two conditions: a treatment group or a waitlist control group. The treatment group takes part in a 4-month multicomponent intervention consisting of: * Digital literacy training, focused on basic smartphone use, and navigation of the Virtual, Inclusive, Together, Active (VITA) application * Access to the VITA mobile application, which supports discovery of and participation in local, interest-based social activities * Ongoing structured support from the research team, aimed at encouraging app use, facilitating social connections, and promoting participation in community-based activities. The control group does not receive digital training, app access, or structured support during the study period. However, participants in this group are offered access to the VITA application after the completion of the follow-up assessment. Study objectives: The primary aims of the study are: * To assess the feasibility and acceptability of a digitally supported, community-based intervention for older adults * To evaluate the impact of the app on social connectedness, loneliness, and psychological well-being, compared to a waitlist control group * To examine changes in digital literacy, attitudes towards technology, and engagement with community activities * To explore how and under which conditions digital tools can effectively support (rather than replace) in-person social interactions in older adulthood This study will contribute to existing literature on digital and psychosocial interventions for older adults by providing evidence on the real-world effectiveness of an integrated, community-oriented digital platform. Findings will inform future large-scale implementations and guide the development of inclusive, age-friendly digital solutions aimed at promoting social participation and improving quality of life in later life.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBlended 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.

Timeline

Start date
2025-11-22
Primary completion
2026-04-30
Completion
2026-07-30
First posted
2026-03-02
Last updated
2026-03-19

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT07443813. Inclusion in this directory is not an endorsement.