Delirium in Old AgeDeliriumNCT03175276
Informant Questionaire on Cognitive Decline in the Elderly (IQCODE) and Delirium in Geriatric Patients
An observational study of Delirium in Old Age and Cognitive Decline, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Delirium in Old Age, Cognitive Decline
- How many people
- 315 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Mar 2017to 31 Jan 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older patients (aged ≥75 years), acutely admitted to ED and transferred to a geriatric ward at Aarhus University Hospital in the period from March to September 2017 for diseases that need either medical or surgical treatment.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predict IQCODE Delirium in Geriatric Patients
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.
Read the 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.
- Conditions
- Delirium in Old Age, Cognitive Decline
- Keywords
- Delirium, Cognitive decline, IQCODE
- Medical subject headings
- Cognitive Dysfunction, Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Delirium diagnosed using the Confusion Assessment Method (CAM) - Danish version. Incidence of delirium is measured by the first positive CAM score.
Measured: Repeated measurements twice a day at 7-11 AM and 5-10 PM until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start20 Mar 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- 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
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Else Marie Damsgaard, Professor, Study chair, Department of Geriatrics , Aarhus University Hospital Palle Juul-Jensens Boulevard 99, Building J, J513, DK-8200 Aarhus N
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175276
- Sponsor's protocol ID
- Cognitive decline and delirium
- Acronym
- Delirium
- Status last verified
- Mar 2017
- First submitted
- 1 Jun 2017
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18285677Siddiqi 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(3):CD005563. doi: 10.1002/14651858.CD005563.pub3.
PubMed 26967259
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predict IQCODE Delirium in Geriatric Patients
- ClinicalTrials.gov ID
- NCT03175276
- Acronym / sponsor ID
- Delirium / Cognitive decline and delirium
- Conditions
- Delirium in Old Age, Cognitive Decline
- Keywords
- Delirium, Cognitive decline, IQCODE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 5 Jun 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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older patients (aged ≥75 years), acutely admitted to ED and transferred to a geriatric ward at Aarhus University Hospital in the period from March to September 2017 for diseases that need either medical or surgical treatment.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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
Delirium
Time frame: 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.
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 25 Apr 2018.
- Background: PubMed 18285677Priner 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.
- Background: PubMed 26967259Siddiqi 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(3):CD005563. doi: 10.1002/14651858.CD005563.pub3.
- 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.
Else Marie Damsgaard, Professor study chair
Department of Geriatrics , Aarhus University Hospital Palle Juul-Jensens Boulevard 99, Building J, J513, DK-8200 Aarhus N
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 in Old Age and Cognitive Decline, run by Aarhus University Hospital at 1 site in Denmark.
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 1 inclusion and 5 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 25 Apr 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 Denmark. 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?
Delirium (time frame: Repeated measurements twice a day at 7-11 AM and 5-10 PM until discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03175276, which also lists 2 linked publications.
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 25 Apr 2018.