NCT06946186

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Apr 2025Jan 2027

First Submitted

Initial submission to the registry

April 13, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

April 23, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

April 13, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

digital access for older adults

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 month

Secondary Outcomes (1)

  • Digital Social Participation (Anderberg et al., 2021; JMIR)

    12 month

Study Arms (3)

GrandPad1

EXPERIMENTAL

This group will receive a GrandPad right away after they complete the baseline survey

Behavioral: Virtual Senior Center - GrandPad

GrandPad2 - 6mo

OTHER

Delayed interventional. This group will receive a GrandPad after 6 months.

Behavioral: Virtual Senior Center - GrandPad

Congregate

ACTIVE COMPARATOR

This group will not receive a GrandPad but will get access to the Virtual Senior Center

Behavioral: Virtual Senior Center - No GrandPad

Interventions

The Virtual Senior Center engages older adults in programs and services online with the help of a GrandPad.

GrandPad1GrandPad2 - 6mo

Participants will be given information to access the website when they are able from their own phone, tablet, or computer.

Congregate

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Current Home-delivered meal client with Aging Ahead

You may not qualify if:

  • Under age 65

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63101, United States

Location

Study Officials

  • Matthew Kreuter, PhD, MPH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Though participants and investigators won't know condition of the randomized groups upon enrollment, they will know when they receive the GrandPad. The 3rd group will not be masked at any point.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kahn Family Professor

Study Record Dates

First Submitted

April 13, 2025

First Posted

April 27, 2025

Study Start

April 23, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

July 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
ANALYTIC CODE
Time Frame
3/31/28 - indefinitely
Access Criteria
Users must register with the repository and agree to the License specified for the project. This license will allow users to adapt and build upon the materials in any format for noncommercial purposes only and so long as attribution is given to the original creators and grant funding. Any adapted or new data formats and accompanying descriptions will also need to be publicly available under identical terms as the original. Additionally, the license will protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibit attempts to identify study participants, and require immediate reporting of any identification of study participant's identity. Data users also agree not to share or redistribute any data downloads.

Locations