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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03662464
Other study ID # 2016-55
Secondary ID IDRCB
Status Recruiting
Phase
First received
Last updated
Start date October 2018
Est. completion date April 2021

Study information

Verified date January 2018
Source Assistance Publique Hopitaux De Marseille
Contact Elisabeth POULIN
Phone 06 79 72 41 09
Email elisabeth.poulin@ap-hm.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 4050
Est. completion date April 2021
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Prognosis less than three months

- Bedridden (not able to move alone from bed to chair)

- Nursing home short stay scheduled < 3 months

Study Design


Related Conditions & MeSH terms

  • Dementia
  • Elopement or Escaping of Nursing Home Resident With or Without Dementia

Intervention

Other:
No intervention
develop and validate a specific tool to score the risk of escaping in Nursing Homes residents

Locations

Country Name City State
France Direction Recherche clinique et Innovation Marseille Paca

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Escape/elopement occurence Each Event occurrence is notify by the nurses staff at any time 2 years