NCT04797026

Brief Summary

The purpose of this research is to study whether sending letters helps reduce loneliness for either the facility resident or the teenager.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

December 30, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

March 11, 2021

Last Update Submit

December 10, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Loneliness Alleviation with Letter Writing

    Writing letters between Long Term Care Residents and Students: Increasing Connection to Alleviate Loneliness

    6 months; may be extended

Study Arms (1)

Penpal Program to Alleviate Loneliness

EXPERIMENTAL

A social program connecting patients in residential care facilities with high school students through monthly letter writing would positively impact quality of life for both, reducing quantitative and qualitative measures of loneliness

Other: Letters to increase social connection with goal to alleviate loneliness

Interventions

Our hypothesis is that a social program connecting patients in residential care facilities with high school students through monthly letter writing would positively impact quality of life for both, reducing quantitative and qualitiative measures of loneliness

Also known as: Letters
Penpal Program to Alleviate Loneliness

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Care facility residents with capacity to make decisions:
  • Measured via their most recent cognitive assessment;
  • Subjectively measured via nursing staff.
  • High school students will be invited via recommendation of their instructors and school administrative staff:
  • Parental permission will be required.

You may not qualify if:

  • Care facility residents that have significant cognitive impairment.
  • Residents who lack decision-making capacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Susan Laabs, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 5 care facility residents paired with a similar amount of students as a pilot. If this program is successful, we will plan to amend IRB to include larger numbers
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 15, 2021

Study Start

September 15, 2021

Primary Completion

March 15, 2022

Study Completion

March 20, 2022

Last Updated

December 30, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share