Clinical trial NCT06946186: Virtual Senior Center
Official title: Achieving Digital Equity for Health Improvement in a Virtual Senior Center
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Social Isolation in Older Adults
Quality of Life (QOL)
Activities of Daily Living
Keywords: digital access for older adults
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-04-27
Enrollment: 650
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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 meals at senior center but no GrandPad.

Detailed description: The aims of the study are:

1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

* Current Home-delivered meal client with Aging Ahead

Exclusion Criteria:

* Under age 65

Primary outcomes:
measure: The Social Isolation Scale in Older Adults (Nicholson et al., 2020; The Gerontologist)
timeFrame: 12 month
Secondary outcomes:
measure: Digital Social Participation (Anderberg et al., 2021; JMIR)
timeFrame: 12 month
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Matthew Kreuter, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: