Social Isolation in Older AdultsVITANCT07443813
An Innovative App-based Intervention to Promote Social Connectedness and Well-being in Older Adults
A study testing Blended VITA intervention (hybrid app-based and in-person social engagement program) in people with Social Isolation in Older Adults and Loneliness, run by University of Padova at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation in Older Adults, Loneliness
- What is being tested?
- Blended VITA intervention (hybrid app-based and in-person social engagement program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual, Inclusive, Together, Active (VITA): An Innovative App-based Intervention to Promote Social Connectedness and Well-being in Older Adults
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.
Read the 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
- Social Isolation in Older Adults, Loneliness
- Being tested
- Blended VITA intervention (hybrid app-based and in-person social engagement program)
- Keywords
- social isolation, loneliness, older adults, aging, social connectedness, community engagement, Mobile application, Randomized controlled trial, Healthy aging
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended VITA intervention (hybrid app-based and in-person social engagement program)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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).
Measured: 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.
Measured: 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.
Measured: Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start22 Nov 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Isolation in Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabrina Cipolletta, Professor, Study director, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443813
- Sponsor's protocol ID
- 1241-b
- Acronym
- VITA
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual, Inclusive, Together, Active (VITA): An Innovative App-based Intervention to Promote Social Connectedness and Well-being in Older Adults
- ClinicalTrials.gov ID
- NCT07443813
- Acronym / sponsor ID
- VITA / 1241-b
- Conditions
- Social Isolation in Older Adults, Loneliness
- Keywords
- social isolation, loneliness, older adults, aging, social connectedness, community engagement, Mobile application, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Blended VITA Intervention (hybrid app-based and in-person delivery) | Experimental | Behavioral: Blended VITA intervention (hybrid app-based and in-person social engagement program)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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Blended VITA Intervention (hybrid app-based and in-person delivery) |
Primary outcome
Change from baseline in social connectedness at post-Intervention and 2-Month follow-Up
Time frame: Baseline (T0), post-intervention at 4 months (T1), and 2-month follow-up (T2)
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.
Change from baseline in social engagement frequency
Time frame: Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)
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.
3 secondary outcomes
Change from baseline in perceived loneliness as measured by the University of California, Los Angeles (UCLA) Loneliness Scale 3-Item
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
Time frame: Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)
Change from baseline in self-perceived digital competence
Time frame: Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina Cipolletta, Professor study director
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blended VITA intervention (hybrid app-based and in-person social engagement program) in people with Social Isolation in Older Adults and Loneliness, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in social connectedness at post-Intervention and 2-Month follow-Up (time frame: Baseline (T0), post-intervention at 4 months (T1), and 2-month follow-up (T2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.