DeliriumNCT03066232
Delirium in Home-dwelling Old People Receiving Home Nursing Care
An observational study of Delirium, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Study the prevalence of delirium among old persons with home-nursing care living in the community. By recruiting the persons in a stable phase, the investigators wish to study the influence of an episode of delirium upon further cognitive and physical function. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium
- How many people
- 211 participants
- Where
- 1 siteNorway
- Study dates
- 11 May 2015to 8 Jul 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Persons older than 65 years living in their own home receiving home nursing care at least once a week.
Who may be able to join
- Home nursing service at least once a week.
- Home dwelling (not permanently institutionalised)
- Age 65 years or more
- Informed consent by the patient or a close relative (if the patient is unable to give a valid informed consent)
Who cannot join
- Patient or relative denies inclusion
- Terminal illness
- Patients diagnosed with dementia with Lewy bodies (its fluctuating course makes the diagnosis of delirium challenging)
- Patients with chronic diseases that have needed assistance from the home nursing service before the age of 65.
- Assistance from the home nursing service is due to addictive substances.
- Assistance from the home nursing service is due to psychiatric illnesses other than dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Study the prevalence of delirium among old persons with home-nursing care living in the community. By recruiting the persons in a stable phase, the investigators wish to study the influence of an episode of delirium upon further cognitive and physical function.
- Conditions
- Delirium
- Keywords
- Delirium, Dementia, Physical function
- Medical subject headings
- Delirium, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Trajectory of cognitive function using the MoCa test
The impact of an episode of delirium upon cognitive function measured by the Montreal Cognitive Assessment every 6th months for two years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start11 May 2015
- Primary completion8 Jul 2018
- Study completion8 Jul 2018
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 Oslo 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sandefjord kommune, Norwegian Centre for Ageing and Health, The Hospital of Vestfold
- Responsible party
- Principal investigator, Maria Krogseth, Oslo University Hospital
- Investigators
- Torgeir Bruun Wyller, MD, PhD, Study chair, Oslo University Hospital, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066232
- Sponsor's protocol ID
- 2014/1972
- Status last verified
- Aug 2018
- First submitted
- 20 Feb 2017
- Last updated
- 22 Aug 2018
- 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 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium in Home-dwelling Old People Receiving Home Nursing Care
- ClinicalTrials.gov ID
- NCT03066232
- Acronym / sponsor ID
- 2014/1972
- Conditions
- Delirium
- Keywords
- Delirium, Dementia, Physical function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sandefjord kommune, Norwegian Centre for Ageing and Health, The Hospital of Vestfold
- Study start
- 11 May 2015 (actual)
- Primary completion
- 8 Jul 2018 (actual)
- Study completion
- 8 Jul 2018 (actual)
- First posted
- 28 Feb 2017 (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.
Study the prevalence of delirium among old persons with home-nursing care living in the community. By recruiting the persons in a stable phase, the investigators wish to study the influence of an episode of delirium upon further cognitive and physical function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Persons older than 65 years living in their own home receiving home nursing care at least once a week.
Key inclusion criteria (4 listed)
- Home nursing service at least once a week.
- Home dwelling (not permanently institutionalised)
- Age 65 years or more
- Informed consent by the patient or a close relative (if the patient is unable to give a valid informed consent)
Key exclusion criteria (6 listed)
- Patient or relative denies inclusion
- Terminal illness
- Patients diagnosed with dementia with Lewy bodies (its fluctuating course makes the diagnosis of delirium challenging)
- Patients with chronic diseases that have needed assistance from the home nursing service before the age of 65.
- Assistance from the home nursing service is due to addictive substances.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trajectory of cognitive function using the MoCa test
Time frame: 2 years
The impact of an episode of delirium upon cognitive function measured by the Montreal Cognitive Assessment every 6th months for two years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- 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.
Torgeir Bruun Wyller, MD, PhD study chair
Oslo University Hospital, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Aug 2018. 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 Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trajectory of cognitive function using the MoCa test (time frame: 2 years). 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 22 Aug 2018.