Study Stopped
Study was terminated after 6 months due to recruitment and data collection challenges.
Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation
1 other identifier
interventional
8
1 country
1
Brief Summary
The aim of the study is to investigate whether supplemental camera observation directly linked to the nurse's phone will improve patient safety for acute medical care patients', who are restless, confused or in risk of development of acute delirium. The setting is an acute medical care ward. The expected result is a reduced incidence of patients with delirious condition, patients who fall or unintentionally remove intravenous access or catheters. Thus, higher patient safety and more efficient patient trajectories are expected, as well as a reduced need for treatment, care and rehabilitation after discharge.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2021
CompletedFirst Posted
Study publicly available on registry
April 12, 2021
CompletedStudy Start
First participant enrolled
April 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedNovember 1, 2021
October 1, 2021
5 months
March 25, 2021
October 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Confusion Assessment Score
Assessed by Confusion Assessment Method (CAM) screening tool. Minimum value is 0, Maximum value is 4. Higher score means higher risk of developing Delirium.
First measurement at admission and second measurement within 24 hours.
Secondary Outcomes (3)
Number of patient falls
The time the patient is assessed during the observation period.
Discontinuation of accesses
The time the patient is assessed during the observation period.
Number of administrations of sedatives
The time the patient is assessed during the observation period.
Study Arms (2)
Camera observation
ACTIVE COMPARATORCamera observation
No camera observation
NO INTERVENTIONNo intervention
Interventions
Supplemental camera observation directly linked to the nurse's phone
Eligibility Criteria
You may qualify if:
- Patients over 65 years of age with a CAM score of 2 or higher.
You may not qualify if:
- paranoia
- severe dementia
- suicidal
- need for permanent guard
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aalborg Universityhospital
Aalborg, 9000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator and postdoc.
Study Record Dates
First Submitted
March 25, 2021
First Posted
April 12, 2021
Study Start
April 19, 2021
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
November 1, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share