- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06946186
Virtual Senior Center (VSC)
Achieving Digital Equity for Health Improvement in a Virtual Senior Center
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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St Louis, Missouri, United States, 63101
- Washington University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Current Home-delivered meal client with Aging Ahead
Exclusion Criteria:
- Under age 65
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GrandPad1
This group will receive a GrandPad right away after they complete the baseline survey
|
The Virtual Senior Center engages older adults in programs and services online with the help of a GrandPad.
|
|
Other: GrandPad2 - 6mo
Delayed interventional.
This group will receive a GrandPad after 6 months.
|
The Virtual Senior Center engages older adults in programs and services online with the help of a GrandPad.
|
|
Active Comparator: Congregate
This group will not receive a GrandPad but will get access to the Virtual Senior Center
|
Participants will be given information to access the website when they are able from their own phone, tablet, or computer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Social Isolation Scale in Older Adults (Nicholson et al., 2020; The Gerontologist)
Time Frame: 12 month
|
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.
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digital Social Participation (Anderberg et al., 2021; JMIR)
Time Frame: 12 month
|
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.
|
12 month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Matthew Kreuter, PhD, MPH, Washington University School of Medicine
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
Other Study ID Numbers
- 202408007
- OT2HL158287 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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