Impact of an Automatic Alert Device on the Occurrence of... | NCT05964972

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

NCT05964972

Sponsor

University Hospital, Caen

Status

Terminated

Last Update Posted

Jul 25, 2025Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Fall Patients

Interventions

Not provided

Countries

France

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 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of patients

Expanded Access Info

Start Date

May 17, 2022Actual

Primary Completion Date

Dec 30, 2023Actual

Completion Date

Dec 30, 2024Actual

First Submitted Date

Jul 20, 2023

First Submission Date that Met QC Criteria

Jul 20, 2023

First Posted Date

Jul 28, 2023Actual

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 22, 2025

Last Update Posted Date

Jul 25, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

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.

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

8Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of falls	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.	6 month preceding and 6 month after

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Fallers

Sampling Method

Non-Probability Sample

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