NCT05391334

Brief Summary

During delirium patients are at risk of severe harm due to unattended bed-exits resulting in falls. This research intends to explore how effective alarming contact mats (CareMat®) in comparison to contactless bed-exit alarming devices (Qumea®) are to reduce the risk of unattended bed-exits and falls.

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
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

May 20, 2022

Last Update Submit

May 9, 2023

Conditions

Delirium in Old AgeDelirium Superimposed on DementiaFallBed Falls

Keywords

bed-exitbed-exit warning devicecontact mat3-D-radar device

Outcome Measures

Primary Outcomes (1)

  • Falls

    Number of patient falls in patient room

    6 months

Secondary Outcomes (5)

  • Bed-exit patterns

    6 months

  • Nurses' workload

    6 months

  • Time to confirm a CareMat® / Qumea® warning by nurse presence in room

    6 months

  • Delirium severity

    6 months

  • Delirium duration

    6 months

Study Arms (2)

Usual Care

Contact mat (CareMat®) for bed-exit detection in combination with Qumea fall detection.

Intervention

Contactless motion sensor (Qumea®) for bed-exit detection in combination with Qumea fall detection.

Device: Qumea

Interventions

QumeaDEVICE

Contactless motion sensor (Qumea®) for bed-exit detection in combination with Qumea fall detection.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with delirium hospitalized on a specialized delirium unit

You may qualify if:

  • Admission at or transferal to DelirUnit. During Covid pandemic, patients will be enrolled into the study after the second negative Covid swab (PCR).

You may not qualify if:

  • Patients who have been sectioned and must be treated in a facility, whether they agree or not (under the mental health act) (Fürsorgliche Unterbringung).
  • No proxy consent available due to language barriers;
  • Missing legal proxy in case of lacking family network

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäre Altersmedizin Felix Platter

Basel, 4055, Switzerland

RECRUITING

Study Officials

  • Wolfgang Hasemann, PhD

    University Department of Geriatric Medicine FELIX PLATTER

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Hasemann, PhD

CONTACT

+41 61 326wolfgang.hasemann@felixplatter.ch

Anke Schurek

CONTACT

+41 61 326Anke.Schurek@felixplatter.ch

Study Design

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

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

November 1, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

CH(1)