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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03175276
Other study ID # Cognitive decline and delirium
Secondary ID
Status Completed
Phase
First received June 1, 2017
Last updated April 24, 2018
Start date March 20, 2017
Est. completion date January 31, 2018

Study information

Verified date March 2017
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate the usefulness of the Informant Questionaire on Cognitive Decline in the Elderly (IQCODE) to predict delirium in elderly patients admitted to Emergency Department (ED) with geriatric assessment and transferred to Geriatric ward.


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.


Recruitment information / eligibility

Status Completed
Enrollment 315
Est. completion date January 31, 2018
Est. primary completion date January 31, 2018
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 Design


Locations

Country Name City State
Denmark Aarhus University hospital Aarhus Central Danmark Region

Sponsors (2)

Lead Sponsor Collaborator
Aarhus University Hospital University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Delirium Delirium diagnosed using the Confusion Assessment Method (CAM) - Danish version. Incidence of delirium is measured by the first positive CAM score. Repeated measurements twice a day at 7-11 AM and 5-10 PM until discharge
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