NCT03662464

Brief Summary

Residents' escapes occur even if most of the nursing homes (NH) have set up specific devices to prevent from this risk. Therefore, the need to develop and validate a specific tool to assess the risk of escaping was obvious to the working group, aim at emphasizing patient centered-care by the nurses' staff and help to develop personalized devices. Aim of the study: develop and validate a specific tool to score the risk of escaping in NH residents Study design: Observational prospective multicentered cohort study Nursing homes volunteer to participate Location: Provence Alpes Cotes d'Azur Region ( South East of France) Population: 4050 NH residents. Duration: two years, each resident included is followed up for one year Measures: Nursing homes characteristics, residents characteristics ( social and from medical record); Escape Scale (25 items with a Yes/no answer; filled up during a nurses staff meeting for each resident and every three months; 3 sub scales: resident environmental items, social items, and medical items.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

October 4, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

August 31, 2018

Last Update Submit

October 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Escape/elopement occurence

    Each Event occurrence is notify by the nurses staff at any time

    2 years

Interventions

develop and validate a specific tool to score the risk of escaping in Nursing Homes residents

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Resident of the nursing homes in Provence Alpes Cotes d'Azur Region ( South East of France)

You may qualify if:

  • Every resident of Nursing home participating to the study
  • Living in the NH for three months or more
  • With a living prognosis longer than 3 Months

You may not qualify if:

  • Prognosis less than three months
  • Bedridden (not able to move alone from bed to chair)
  • Nursing home short stay scheduled \< 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Direction Recherche clinique et Innovation

Marseille, PACA, 13354, France

RECRUITING

Study Officials

  • Jean-Olivier ARNAUD

    Assitance Publique des Hopitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Sylvie Bonin-Guillaume

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 7, 2018

Study Start

October 1, 2018

Primary Completion

October 1, 2020

Study Completion

April 1, 2021

Last Updated

October 4, 2018

Record last verified: 2018-01

Locations