Companion Dog & Loneliness in Elderly Persons | NCT04032340

Studies
Companion Dog & Loneliness in Elderly Persons

NCT04032340

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Jul 25, 2019Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Elderly
Companion Dog
Home Based
Loneliness

Interventions

dog presence

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2020Estimated

Primary Completion Date

Jan 2022Estimated

Completion Date

Jan 2022Estimated

First Submitted Date

Jul 23, 2019

First Submission Date that Met QC Criteria

Jul 23, 2019

First Posted Date

Jul 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2019

Last Update Posted Date

Jul 25, 2019Actual

Name	Class
Fondation MUTAC	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
dog presence	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
assessment of loneliness using Jong Gierveld scale (11items).	emotional dimension (6items) social dimension (5items)	5 to 10 days after inclusion visit

Secondary Outcomes

Measure	Description	Time Frame
social isolation	Social Network Index french version (http://dx.doi.org/10.13072/midss.464)	5 to 10 days after inclusion visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

person aged ≥ 75years old
living at home

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
FLORENCE CANOUI-POITRINE, MD-PHD	Contact	0149813695		florence.canoui-poitrine@aphp.fr

Overall Officials

Name	Affiliation	Role
FLORENCE CANOUI-POITRINE, MD-PHD	APHP CHU HENRI MONDOR	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided