Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium

NCT ID: NCT05391334

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Delirium is a neuropsychiatric disorder with a sudden and reversible decline in attention and cognition due to a medical condition.8 Delirium is associated with emotional distress for patients, their relatives and medical staff.3-5 During delirium, patients are at risk of severe harm due to unattended bed-exits and subsequent falls.6, 7 As worldwide strategy, sitters are used for the prevention of harm in patients with delirium. However, evidence of the effectiveness of sitters is scant.9 A newly designed specialised acute care unit for older patients with delirium, the FELIX PLATTER delirium unit (DelirUnit), strives to overcome the aforementioned shortcomings. On the DelirUnit there are no physical barriers such as bed rails to prevent patients from bed-exits. Floor beds minimize injuries when patients leave their beds unattended. Specialised nurses and nursing aides care for this vulnerable patient group. Sitters are banned. As an alternative to sitters, nurses are informed about patients' intended bed-exit by electronic alarming contact mats at the bedside or in front of beds (CareMat®) or by a novel contactless radar-based bed-exit monitoring system (Qumea®). Up until now, evidence for the effectiveness of technical devices for fall risk prevention is low. This research intends to explore how effective contact mats (CareMat®) or contactless bed-exit alarming devices (Qumea®) are in fall risk detection and fall prevention.

Conditions

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Delirium in Old Age Delirium Superimposed on Dementia Fall Bed Falls

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Usual Care

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

No interventions assigned to this group

Intervention

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

Qumea

Intervention Type DEVICE

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

Interventions

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Qumea

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Basel

OTHER

Sponsor Role collaborator

Velux Stiftung

UNKNOWN

Sponsor Role collaborator

University Department of Geriatric Medicine FELIX PLATTER

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolfgang Hasemann, PhD

Role: PRINCIPAL_INVESTIGATOR

University Department of Geriatric Medicine FELIX PLATTER

Locations

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Universitäre Altersmedizin Felix Platter

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Wolfgang Hasemann, PhD

Role: CONTACT

+41 61 326 ext. 4068

Anke Schurek

Role: CONTACT

+41 61 326 ext. 4022

Facility Contacts

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Wolfgang Hasemann, PhD

Role: primary

0041 61 326 ext. 4068

Other Identifiers

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QumEKNZV2

Identifier Type: -

Identifier Source: org_study_id

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