Università degli Studi di Padova
Padova, PD, 35139, Italy
NCT Number: NCT07443813
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.
This study is active but is not currently recruiting participants.
Notify Me65 year and older
All sexes
Interventional
Not applicable
Padova, PD, 35139, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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).
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.
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.
University of Padova
Other
Virtual, Inclusive, Together, Active (VITA): An Innovative App-based Intervention to Promote Social Connectedness and Well-being in Older Adults
Acronym: VITA
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