DeliriumNCT04841122
Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation
A study testing Camera observation in people with Delirium, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Delirium
- What is being tested?
- Camera observation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Apr 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 65 years of age with a CAM score of 2 or higher.
Who cannot join
- paranoia
- severe dementia
- suicidal
- need for permanent guard
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Delirium
- Being tested
- Camera observation
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camera observationDevice
Supplemental camera observation directly linked to the nurse's phone
| Study group | Role | What they receive |
|---|---|---|
| Camera observation | Active comparator | Camera observation Receives: Device: Camera observation |
| No camera observation | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First measurement at admission and second measurement within 24 hours.
Secondary outcomes (3)
Number of patient falls
Incidence of patient falls observed by the nurse during the observation period.
Measured: The time the patient is assessed during the observation period.
Discontinuation of accesses
Number of patient discontinuation of e.g. oxygen mask, peripheral venous catheter, bladder catheters
Measured: The time the patient is assessed during the observation period.
Number of administrations of sedatives
Number of OR administrations and number of IV administrations (specific sedatives e.g. Methylphenidate, Haloperidol, Midazolam).
Measured: The time the patient is assessed during the observation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start19 Apr 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Why it stopped: Study was terminated after 6 months due to recruitment and data collection challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Geil Kollerup, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841122
- Sponsor's protocol ID
- N-20200079
- Status last verified
- Oct 2021
- First submitted
- 25 Mar 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation
- ClinicalTrials.gov ID
- NCT04841122
- Acronym / sponsor ID
- N-20200079
- Conditions
- Delirium
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated after 6 months due to recruitment and data collection challenges.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camera observation | Active comparator | Device: Camera observationCamera observation |
| No camera observation | No intervention | –No intervention |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients over 65 years of age with a CAM score of 2 or higher.
Key exclusion criteria (4 listed)
- paranoia
- severe dementia
- suicidal
- need for permanent guard
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camera observationSupplemental camera observation directly linked to the nurse's phone | Device | Camera observation |
Primary outcome
Change in Confusion Assessment Score
Time frame: First measurement at admission and second measurement within 24 hours.
Assessed by Confusion Assessment Method (CAM) screening tool. Minimum value is 0, Maximum value is 4. Higher score means higher risk of developing Delirium.
3 secondary outcomes
Number of patient falls
Time frame: The time the patient is assessed during the observation period.
Discontinuation of accesses
Time frame: The time the patient is assessed during the observation period.
Number of administrations of sedatives
Time frame: The time the patient is assessed during the observation period.
Results and safety
The study was stopped early (reason given: Study was terminated after 6 months due to recruitment and data collection challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camera observation in people with Delirium, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated after 6 months due to recruitment and data collection challenges.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Confusion Assessment Score (time frame: First measurement at admission and second measurement within 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.