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

NCT07443813 | Active Not Recruiting

• 1 other identifier: 1241-b
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Isolation in Older Adults; Loneliness

Keywords

social isolation; loneliness; older adults; aging; social connectedness; community engagement; Mobile application; Randomized controlled trial; Healthy aging

Outcome Measures

Primary Outcomes (2)

• Change from baseline in social connectedness at post-Intervention and 2-Month follow-Up

  This outcome evaluates changes in participants' social connectedness and interactions resulting from the Virtual, Inclusive, Together, Active (VITA) intervention. Social connectedness is measured using the Multidimensional Scale of Perceived Social Support (MSPSS), a 12-item self-report instrument assessing perceived support from family, friends, and significant others. Each item is rated on a 7-point Likert scale (1 = very strongly disagree to 7 = very strongly agree). Total scores range from 12 to 84, with higher scores indicating greater perceived social support (better outcome). Additional indicators include self-reported participation in community activities and frequency of peer interactions. These complementary measures provide contextual information on changes in social participation and interaction patterns over time.

  Baseline (T0), post-intervention at 4 months (T1), and 2-month follow-up (T2)

• Change from baseline in social engagement frequency

  This outcome assesses changes in the frequency and extent of participants' social engagement over the course of the intervention. Social engagement is measured using self-reported questionnaires that capture the number and regularity of interactions with family, friends, neighbors, and participation in community or group activities. This measure allows evaluation of whether the VITA app-based intervention, along with facilitated social connections, increases older adults' active involvement in social and community life, supporting improved social integration, peer interaction, and overall well-being.

  Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)

Secondary Outcomes (3)

• Change from baseline in perceived loneliness as measured by the University of California, Los Angeles (UCLA) Loneliness Scale 3-Item

  Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)

• Change from baseline in psychological well-being as measured by the Ryff Psychological Well-Being Scale

  Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)

• Change from baseline in self-perceived digital competence

  Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)

Study Arms (2)

Blended VITA Intervention (hybrid app-based and in-person delivery)

EXPERIMENTAL

Participants receive structured digital literacy training on the use of the Virtual, Inclusive, Together, Active (VITA) mobile application and have full access to the app during the 4-month intervention period. Through the app, they can discover social opportunities in their neighborhoods offered by local organizations and community groups, and they can also create and share social opportunities with other participants in the treatment group. The research team provides ongoing support by facilitating social connections among participants who live nearby and share similar interests, and by offering guidance on using the app effectively. The intervention promotes active participation in local community activities, peer interactions, and engagement with events in the surrounding community. Assessments are conducted at baseline, post-intervention, and at a 2-month follow-up.

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

Control Group / Waiting-list

NO INTERVENTION

Participants in this group continue with their usual social and community activities and do not receive immediate access to the VITA mobile application. They do not participate in digital literacy training sessions or receive any facilitation of social connections from the research team during the 4-month intervention period. Assessments are conducted at the same time points as the intervention group: baseline, post-intervention, and 2-month follow-up, to allow for direct comparisons between groups. After the study period concludes, participants in this wait-list control group are provided access to the VITA app, enabling them to use the platform and benefit from its features, including discovering local social opportunities and connecting with peers, if they wish. This design ensures that all participants eventually have the opportunity to engage with the intervention while maintaining the integrity of the controlled comparison.

Interventions

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

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.

Blended VITA Intervention (hybrid app-based and in-person delivery)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Università degli Studi di Padova

Padua, PD, 35139, Italy

Location

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Sabrina Cipolletta, Professor

  University of Padova

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will use a parallel-group randomized controlled trial design to examine the impact of a digitally supported, community-based intervention on older adults' social connectedness and psychological well-being. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group (immediate access to the Virtual, Inclusive, Together, Active mobile application, digital literacy training, and ongoing researcher facilitation) or the control group (waitlist, with access to the application after completion of the follow-up assessment). Randomization will be computer-generated and stratified by geographic area and neighborhood groups to ensure balanced allocation across local districts. Outcomes will be assessed at baseline, post-intervention, and at follow-up.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: March 2, 2026
• Study Start: November 22, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)