Social Isolation in Older AdultsVSCNCT06946186
Virtual Senior Center
A study testing Virtual Senior Center - GrandPad and Virtual Senior Center - No GrandPad in people with Social Isolation in Older Adults and Quality of Life (QOL), run by Washington University School of Medicine at 1 site in United States.
Trial summary
In a 3-group trial with randomization and follow-up for 12 months, we will compare use of the VSC as well as health and quality of life outcomes among 650 older adults in St. Louis who receive either: (1) home delivered meals AND a GrandPad; (2) home-delivered meals but no GrandPad for 6 months; and (3) in person… 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, Quality of Life (QOL), Activities of Daily Living
- What is being tested?
- Virtual Senior Center - GrandPad and Virtual Senior Center - No GrandPad
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2025to Jan 2028
- Phase
- Interventional
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
- Current Home-delivered meal client with Aging Ahead
Who cannot join
- Under age 65
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Achieving Digital Equity for Health Improvement in a Virtual Senior Center
In a 3-group trial with randomization and follow-up for 12 months, we will compare use of the VSC as well as health and quality of life outcomes among 650 older adults in St. Louis who receive either: (1) home delivered meals AND a GrandPad; (2) home-delivered meals but no GrandPad for 6 months; and (3) in person meals at senior center but no GrandPad.
Read the detailed description
The aims of the study are:
- Recruit 650 older adults in St. Louis into the study - 400 home-delivered meal recipients and 250 receiving in-person meals at senior centers. Describe baseline differences between the two groups in use of senior center programming, technology access and use, and health and quality of life outcomes.
- Randomly assign the 400 home-delivered meal recipients to get a GrandPad immediately (GP) or 6 months later (GP-6). Compare the GP and GP-6 groups to in-person meal recipients (IP) on: (A) VSC engagement at 6- and 12-month follow-up; and (B) health and quality of life outcomes at 6- and 12-month follow-up.
- Examine longitudinal changes and hypothesized mediating pathways using 5 waves of data from baseline, 3-,6-,9- and 12-month follow-up. Specifically: (A) in the GP-6 group only, compare VSC engagement, health and quality of life outcomes at 6-month follow-up (a period in which they did not have a GrandPad) to 12-month follow-up (a period in which they did have a GrandPad); (B) examine 12-month trends in GrandPad and VSC engagement, health and quality of life outcomes within and across groups; and (C) test mediation of hypothesized explanatory variables from the study's conceptual framework to examine potential causal pathways for health and quality of life outcomes.
- Being tested
- Virtual Senior Center - GrandPad, Virtual Senior Center - No GrandPad
- Keywords
- digital access for older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Senior Center - GrandPadBehavioural
The Virtual Senior Center engages older adults in programs and services online with the help of a GrandPad.
Virtual Senior Center - No GrandPadBehavioural
Participants will be given information to access the website when they are able from their own phone, tablet, or computer.
| Study group | Role | What they receive |
|---|---|---|
| GrandPad1 | Experimental | This group will receive a GrandPad right away after they complete the baseline survey Receives: Behavioral: Virtual Senior Center - GrandPad |
| GrandPad2 - 6mo | Other | Delayed interventional. This group will receive a GrandPad after 6 months. Receives: Behavioral: Virtual Senior Center - GrandPad |
| Congregate | Active comparator | This group will not receive a GrandPad but will get access to the Virtual Senior Center Receives: Behavioral: Virtual Senior Center - No GrandPad |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Social Isolation Scale in Older Adults (Nicholson et al., 2020; The Gerontologist)
This 6-item questionnaire measures the extent to which an individual feels socially unconnected, using 2 related constructs (3 items per construct): quantity of social contacts and sense of relationship. The response options for social contacts ranges from 1 (none) to 5 (6 or more) and the sense of relationship ranges from 1(strongly disagree) to 5 (strongly agree). The possible summed scores range from 6 to 30, with higher scores indicating less social isolation.
Measured: 12 month
Secondary outcomes (1)
Digital Social Participation (Anderberg et al., 2021; JMIR)
This 6-item questionnaire measures extent to which someone feels that digital technology is beneficial in their life. Response options range from 1 (strongly disagree) to 5 (strongly agree), so total summed scores range from 6 -30. A higher scores indicates more positive perceptions of digital technology.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start23 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (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.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Participants in 2 of the groups will be randomly assigned to receive the intervention immediately or in 6 month. The 3rd groups is naturally occurring comparison.
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Matthew Kreuter, Washington University School of Medicine
- Investigators
- Matthew Kreuter, PhD, MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946186
- Sponsor's protocol ID
- 202408007
- Other IDs
- OT2HL158287
- Acronym
- VSC
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw survey response data including dates collected, as well as participant ID codes generated for this study will be shared in order to link the five waves of survey data as well as documentation of participation. All respondent identifiers (e.g., names, addresses) will be removed before sharing. Final de-identified intervention data and Common Survey 4 data will be shared with the CEAL (community engagement Alliance) Technical Assistance Team. Other CEAL researchers will be allowed to request common survey data. We will share all publicly accessible files on WashU Research Data, an institutional repository managed by the Washington University in St. Louis Libraries that uses a cloud-based hosted repository service called TIND as its platform. TIND is based on the open-source Invenio software developed at the research institute CERN to manage its own scholarly output. TIND uses an OAIS-compliant approach to preservation, with redundancy backup, conversion to archival file format