An interventional study of Blended VITA intervention (hybrid app-based and in-person social engagement program) in Social Isolation in Older Adults and Loneliness, sponsored by University of Padova. Active, not recruiting at 1 site in Italy. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by University of Padova · Not applicable, Interventional, and Prevention
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.
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:
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:
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:
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.
236 studies on the registry are indexed under Social Isolation; 61 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 198 interventional studies indexed under Social Isolation.
Browse Social Isolation studies →University of Padova is the lead sponsor of 215 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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.
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.
Time frame: 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.
Time frame: Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)
Change from baseline in perceived loneliness as measured by the University of California, Los Angeles (UCLA) Loneliness Scale 3-Item
Change from baseline in perceived loneliness as measured by the University of California, Los Angeles (UCLA) Loneliness Scale - 3-Item Version. This outcome evaluates changes in participants' perceived loneliness over the course of the intervention. Perceived loneliness is measured using the University of California, Los Angeles (UCLA) Loneliness Scale - 3-Item Version, a validated self-report instrument assessing subjective feelings of social isolation and lack of companionship. Each of the three items is rated on a 3-point Likert scale (1 = hardly ever, 2 = some of the time, 3 = often). Total scores range from 3 to 9, with higher scores indicating greater perceived loneliness (worse outcome).
Time frame: 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
This outcome evaluates changes in participants' psychological well-being over the course of the intervention. Psychological well-being is measured using the Psychological Well-Being Scale (PWS; min = 18, max = 108; higher scores indicate greater well-being), a standardized self-report instrument assessing multiple dimensions of positive psychological functioning. Total scores are calculated by summing item responses, with higher scores reflecting better psychological well-being (better outcome). This measure allows assessment of whether engagement in the VITA blended social intervention and facilitated community activities leads to meaningful improvements in overall psychological functioning and life satisfaction.
Time frame: Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)
Change from baseline in self-perceived digital competence
This secondary outcome evaluates changes in participants' perceived digital competence following participation in the VITA blended intervention. Self-perceived digital competence is assessed using a study-specific single-item question: "How would you rate your computer/digital skills?". Responses are recorded on a 5-point ordinal scale: 1 = Poor, 2 = Fair,3 = Adequate,4 = Good,5 = Excellent.Scores range from 1 to 5, with higher scores indicating greater self-perceived digital competence (better outcome). Changes over time will be analyzed to determine whether the structured digital literacy training and guided app use provided in the VITA intervention enhance participants' perceived technological competence and support sustained engagement with the blended intervention.
Time frame: Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)
Plan to share: No — Individual participant data will not be shared in order to protect the privacy and confidentiality of the individuals participating in the study. All collected information will be anonymized and used exclusively by the research team for analysis of study outcomes.
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Apr 2026, 5 months after the start.
Of 155 non-industry interventional studies with no phase under Social Isolation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 5 months is below that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.