- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03066232
Delirium in Home-dwelling Old People Receiving Home Nursing Care
August 21, 2018 updated by: Maria Krogseth, Oslo University Hospital
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
211
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sandefjord, Norway
- Sandefjord kommune
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Persons older than 65 years living in their own home receiving home nursing care at least once a week.
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trajectory of cognitive function using the MoCa test
Time Frame: 2 years
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The impact of an episode of delirium upon cognitive function measured by the Montreal Cognitive Assessment every 6th months for two years.
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Torgeir Bruun Wyller, MD, PhD, Oslo University Hospital, University of Oslo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2015
Primary Completion (Actual)
July 8, 2018
Study Completion (Actual)
July 8, 2018
Study Registration Dates
First Submitted
February 20, 2017
First Submitted That Met QC Criteria
February 22, 2017
First Posted (Actual)
February 28, 2017
Study Record Updates
Last Update Posted (Actual)
August 22, 2018
Last Update Submitted That Met QC Criteria
August 21, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/1972
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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