- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03175276
Informant Questionaire on Cognitive Decline in the Elderly (IQCODE) and Delirium in Geriatric Patients (Delirium)
Predict IQCODE Delirium in Geriatric Patients
Study Overview
Status
Conditions
Detailed Description
Design: The project will be conducted as a prospective study.
Methods:
Exposure: The short IQCODE is a 16-item questionnaire that ask relatives about changes in the elderly patients cognitive performance over the previous 10 years. The score range from one to five, with a high score reflecting bad evolution through the years.
Settings: Patients (aged ≥75 years) admitted to ED (medical and surgery) and transferred to a geriatric ward at Aarhus University Hospital, who meet the inclusion criteria will be asked if the staff is allowed to contact their relatives. By oral consent, the relatives are interviewed by telephone or at the hospital. The IQCODE are filled in during the interview.
In the geriatric ward the assessment of delirium by a positive Confusion Assesment Method (CAM) is done twice a day and is part of the regular procedure in the Geriatric Department at Aarhus University Hospital.
Sample size: The power calculation is based on a pilot study of IQCODE. The study that included 32 75-year-olds from geriatric ward at Aarhus University hospital, showed an no incidence of delirium of when the IQCODE-score was ≤3,125. On the contrary the incidence of delirium was 15% when the IQCODE-score was >3,125. With a power of 90% and a significance level of 5%, 76 patients should be included in each group to predict delirium.
Time frame: Of the 80 admitted to the geriatric wards, only 20% in the pilot study had an IQCODE-score ≤3,125. With an expected response rate of 70%, the data collection period is expected to last five months.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Central Danmark Region
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Aarhus, Central Danmark Region, Denmark, 8200
- Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients admitted to the emergency medical and surgery ward and transferred to a geriatric ward at Aarhus University Hospital in the period from the 20th of March to September 2017.
Exclusion Criteria:
- Patients transferred to the geriatric ward in the evening and night as well as weekends and holidays, when there is no Geriatric staff present.
- Patients who upon admission are dying assessed by a geriatrician
- Patients with stroke where aphasia is present
- Patients with severe dementia without language
- Patients who are inability to understand or speak Danish
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delirium
Time Frame: Repeated measurements twice a day at 7-11 AM and 5-10 PM until discharge
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Delirium diagnosed using the Confusion Assessment Method (CAM) - Danish version.
Incidence of delirium is measured by the first positive CAM score.
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Repeated measurements twice a day at 7-11 AM and 5-10 PM until discharge
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Else Marie Damsgaard, Professor, Department of Geriatrics , Aarhus University Hospital Palle Juul-Jensens Boulevard 99, Building J, J513, DK-8200 Aarhus N
Publications and helpful links
General Publications
- Siddiqi N, Harrison JK, Clegg A, Teale EA, Young J, Taylor J, Simpkins SA. Interventions for preventing delirium in hospitalised non-ICU patients. Cochrane Database Syst Rev. 2016 Mar 11;3:CD005563. doi: 10.1002/14651858.CD005563.pub3.
- Priner M, Jourdain M, Bouche G, Merlet-Chicoine I, Chaumier JA, Paccalin M. Usefulness of the short IQCODE for predicting postoperative delirium in elderly patients undergoing hip and knee replacement surgery. Gerontology. 2008;54(2):116-9. doi: 10.1159/000117574. Epub 2008 Feb 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cognitive decline and delirium
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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