- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443813
An Innovative App-based Intervention to Promote Social Connectedness and Well-being in Older Adults (VITA)
Virtual, Inclusive, Together, Active (VITA): An Innovative App-based Intervention to Promote Social Connectedness and Well-being in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
PD
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Padua, PD, Italy, 35139
- Universita Degli Studi Di Padova
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blended VITA Intervention (hybrid app-based and in-person delivery)
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.
|
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. |
|
No Intervention: Control Group / Waiting-list
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline (T0), post-intervention at 4 months (T1), and 2-month follow-up (T2)
|
|
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.
|
Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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). |
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)
|
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.
|
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)
|
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.
|
Baseline (T0), immediately post-intervention (T1, 4 months), and 2-month follow-up (T2)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sabrina Cipolletta, Professor, University of Padova
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1241-b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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