Informant Questionaire on Cognitive Decline in the Elderly (IQCODE) and Delirium in Geriatric Patients

Sponsor
Aarhus University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03175276
Collaborator
University of Aarhus (Other)
315
1
10.4
30.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    315 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Predict IQCODE Delirium in Geriatric Patients
    Actual Study Start Date :
    Mar 20, 2017
    Actual Primary Completion Date :
    Jan 31, 2018
    Actual Study Completion Date :
    Jan 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Delirium [Repeated measurements twice a day at 7-11 AM and 5-10 PM until discharge]

      Delirium diagnosed using the Confusion Assessment Method (CAM) - Danish version. Incidence of delirium is measured by the first positive CAM score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University hospital Aarhus Central Danmark Region Denmark 8200

    Sponsors and Collaborators

    • Aarhus University Hospital
    • University of Aarhus

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Aarhus University Hospital
    ClinicalTrials.gov Identifier:
    NCT03175276
    Other Study ID Numbers:
    • Cognitive decline and delirium
    First Posted:
    Jun 5, 2017
    Last Update Posted:
    Apr 25, 2018
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aarhus University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 25, 2018