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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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11 February 2019 |
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Main ID: |
ISRCTN56463078 |
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Date of registration:
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01/06/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Validation study of a delirium detection tool completed by families
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Scientific title:
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Evaluation of the psychometric properties of a delirium detection tool completed by families in cardiology |
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Date of first enrolment:
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18/06/2018 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://isrctn.com/ISRCTN56463078 |
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Study type:
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Observational |
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Study design:
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Validation study (Screening)
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Tanya
Mailhot |
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Address:
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Montreal Heart Institute
5000 Belanger Street, #S-2490
H1T 1C8
Montreal
Canada |
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Telephone:
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Email:
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Affiliation:
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Name:
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Address:
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Telephone:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. The family caregiver had to identify as a family caregiver (spouse, child, other family, friend) of an inpatient
2. Report having regular contact before hospitalization (= once a week). In the literature, this frequency of interaction was considered sufficient for the family member to report the usual cognitive and functional state of the patient, a knowledge necessary to be able to identify changes (Martins et al., 2014; Steis et al., 2012)
3. Have visited the patient at the hospital at least twice
4. Have the capacity to provide informed consent
5. 18 years old or older
6. Understand and read French
7. The hospitalized patient had to have the ability to provide informed consent or have a legal representative if their cognitive functioning was altered and present a stable clinical condition, allowing the evaluation of delirium using a questionnaire such as FAMCAM
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Delirium
Mental and Behavioural Disorders
Delirium, unspecified
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Intervention(s)
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The original English version of the FAM-CAM was translated and culturally adapted to French for Quebec, Canada with the method suggested by Sousa and Rojjanasrirat (2011). The process included obtaining the copyright clearance from the author for use and translation; double forward and backward translations; expert committee decision making and assessment of degree of clarity of the translated version by members of the population. Following this a validation study was performed using the French FAM-CAM. There is no follow-up planned in this study.
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Primary Outcome(s)
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The sensitivity and specificity of the French FAM-CAM compared with the reference standard (medical diagnosis according to DSM-5 criteria)
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Secondary Outcome(s)
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1. The sensitivity and specificity of the French FAM-CAM compared with delirium defined from a set of keywords associated with delirium (encephalopathy, confusion, agitation, hallucination, somnolence, haldol [Puelle et al., 2015]) and with scores on the Confusion Assessment Method (CAM)
2. The FAMCAM’s predictive value compared with the reference standard using a ROC curve
3. The reliability of the FAM-CAM compared with the CAM
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Secondary ID(s)
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ICM 2019-2426
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Source(s) of Monetary Support
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Montreal Heart Institute Foundation
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Ethics review
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Status:
Approval date:
Contact:
Montreal Heart Institute Ethics Board - approval pending
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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15/06/2019 |
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URL:
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