NCT04032340

Brief Summary

Elderly may have problems to create personal connections or to have physical activities in their day- to - day life; loneliness and social isolation may increase fragility in this population. Companion dog presence favours social relations, affective feelings and physical exercises. On the other hand dog presence raises risk of falling and has a cost for its owner. This project seeks to assess positive impacts of companion dog presence in elderly living at home. This transdisciplinar study (general practionners, veterinarians, dog instructors, nurses, researchers) evaluates loneliness and social isolation between elderly with or without a companion dog at home. Objective:To Evaluate the link between companion dog presence and loneliness in elderly persons living at home Method: An Observational, multicentric, transversal, national, comparative study (elderly with companion dog vs elderly without a dog). 200 subjects needed

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Status
unknown

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

First Submitted

Initial submission to the registry

July 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

July 23, 2019

Last Update Submit

July 23, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of loneliness using Jong Gierveld scale (11items).

    emotional dimension (6items) social dimension (5items)

    5 to 10 days after inclusion visit

Secondary Outcomes (1)

  • social isolation

    5 to 10 days after inclusion visit

Study Arms (2)

Elderly with a companion dog

elderly living at home with a dog consulting his family doctor

Other: dog presence

Elderly without a companion dog

elderly living at home without a dog consulting his family doctor

Interventions

This project seeks to assess positive impacts of companion dog presence in elderly living at home ; to assess loneliness and isolement between eldlery with a companion dog and without, at home

Elderly with a companion dog

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly (≥75 years old) living at home, with or without a companion dog, visiting their doctor

You may qualify if:

  • person aged ≥ 75years old
  • living at home

You may not qualify if:

  • bedridden person
  • person accompanied by any animal, other than a dog
  • EPHAD based (establishments providing care for the dependent elderly)
  • comprehension or reading difficulties in french affecting study participation and scales assessment
  • cognitive, mental ou psychic disorders
  • person under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • FLORENCE CANOUI-POITRINE, MD-PHD

    APHP CHU HENRI MONDOR

    PRINCIPAL INVESTIGATOR

Central Study Contacts

FLORENCE CANOUI-POITRINE, MD-PHD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 25, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share