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NCT03552328 · ClinicalTrials.gov registry record · NA
Effects of a Volunteer-based Lunch Program on Feelings of Loneliness in Elders
A NA study of Depression and Anxiety, sponsored by University of South Florida.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03552328: Completed NA study of Depression and Anxiety, sponsored by University of South Florida.
NCT03552328 is a NA study of Depression and Anxiety that has completed, run by University of South Florida. The registered enrollment target is 16 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03552328, a NA study of Depression and Anxiety, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: There is a need for stronger community involvement with the elderly, specifically those with feelings of loneliness. Large proportions of elders in previous studies reported feelings of loneliness, and loneliness at advanced ages is a growing trend seen within the last thirty years despite advances in technology and social media. We propose a randomized control trial to determine the effectiveness of a volunteer-based lunch program on decreasing feelings of loneliness in elderly participants. Methods: Lonely elders in the community will be identified and matched with a trained medical student. Each student will bring provided lunches once a week to their elder participant's residence, and they will share lunch together for an hour once a week for six weeks. Enrollees are eligible for the study if they are over 60 years of age, speak English, have feelings of loneliness on the three-item scale, and display no cognitive impairment. The participants will be assessed pre and post intervention using the R-UCLA scale for loneliness, PHQ-9 for depressive symptoms, and GAD-7 for feelings of anxiety. Participant satisfaction will be assessed using Likert items as well as open-ended questions. Intervention group responses will be compared to responses of participants that did not receive the lunch meeting intervention. Discussion: Success of such a companion lunch program would provide an effective route to combat loneliness in the elderly.
Primary Outcome
Investigators will measure change from baseline feelings of loneliness in elderly participants. Responses are scored from 20 (minimum) to 80 (maximum). Only total scores are reported. Lower values represent a better outcome, i.e. less feelings of loneliness.
Conditions Studied
Interventions
- OTHER Control
- OTHER Lunch with Medical Student
Study Locations (1)
Florida
- Morsani College of Medicine - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-10-15 |
| Est. Completion | 2019-05-15 |
| Phase | NA |
What the finished NCT03552328 record still lists
NCT03552328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT03552328 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03552328 about?
NCT03552328 is a clinical study titled "Effects of a Volunteer-based Lunch Program on Feelings of Loneliness in Elders". Background: There is a need for stronger community involvement with the elderly, specifically those with feelings of loneliness. Large proportions of elders in previous studies reported feelings of loneliness, and loneliness at advanced ages is a growing trend seen within the last thirty years despi...
What is the current status of trial NCT03552328?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2018-10-15. Estimated completion is 2019-05-15.
What conditions does trial NCT03552328 study?
This clinical trial studies the following conditions: Depression, Anxiety, Loneliness, Aged.
What interventions are being tested in trial NCT03552328?
The interventions under investigation include: Control (OTHER), Lunch with Medical Student (OTHER).
Who is sponsoring clinical trial NCT03552328?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03552328 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03552328's enrollment target sits among peer trials
16 635th of 679 higher than 40 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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