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NOCTUSAFE: Impact of an Automatic Alert Device on the Occurrence of Nocturnal Falls in Nursing Home Residents

Sponsor
University Hospital, Caen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05964972
Collaborator
(none)
14
Enrollment
1
Location
16.5
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Impact of an automatic alert device on the occurrence of nocturnal falls in nursing home residents Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per registered resident in the 6 months preceding use of the device compared with the number of nocturnal falls in the 6 months after installation of the device.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    14 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Cross-Sectional
    Official Title:
    Impact of an Automatic Alert Device on the Occurrence of Nocturnal Falls in Nursing Home Residents
    Actual Study Start Date :
    May 17, 2022
    Anticipated Primary Completion Date :
    Jul 30, 2023
    Anticipated Study Completion Date :
    Sep 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. number of falls [6 month preceding and 6 month after]

      Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per registered resident in the 6 months preceding use of the device compared with the number of nocturnal falls in the 6 months after installation of the device.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Resident of the elderly nursing home (EHPAD LES ORCHIDEES).

    • Repeated nocturnal falls (more than 2 falls at night between 8 p.m. and 8 a.m.) during the last 12 months.

    • Consent of the resident or his legal representative.

    • Signature of informed consent

    • French-speaking resident.

    Exclusion Criteria:

    • Refusal to participate in the study.

    • Resident exclusive day faller.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ehpad Les Orchidees Cagny France

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT05964972
    Other Study ID Numbers:
    • 19-145
    First Posted:
    Jul 28, 2023
    Last Update Posted:
    Jul 28, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 28, 2023