跳至主要内容
临床试验/NCT06946186
NCT06946186Enrolling By Invitation不适用

Achieving Digital Equity for Health Improvement in a Virtual Senior Center

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2025年4月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
650
试验地点
2
主要终点
The Social Isolation Scale in Older Adults (Nicholson et al., 2020; The Gerontologist)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

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.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current Home-delivered meal client with Aging Ahead

排除标准

  • Under age 65

研究组 & 干预措施

GrandPad2 - 6mo

Other

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

干预措施: Virtual Senior Center - GrandPad (Behavioral)

GrandPad1

Experimental

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

干预措施: Virtual Senior Center - GrandPad (Behavioral)

Congregate

Active Comparator

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

干预措施: Virtual Senior Center - No GrandPad (Behavioral)

结局指标

主要结局

The Social Isolation Scale in Older Adults (Nicholson et al., 2020; The Gerontologist)

时间窗: 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.

次要结局

  • Digital Social Participation (Anderberg et al., 2021; JMIR)(12 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Kreuter

Kahn Family Professor

Washington University School of Medicine

研究点 (2)

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