Condition category
Mental and Behavioural Disorders
Date applied
23/05/2018
Date assigned
01/06/2018
Last edited
12/10/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Delirium among patients hospitalized in cardiology is widespread but challenging to identify. Family members are an untapped resource for detecting delirium as they know the patients’ baseline level of cognitive function, which is key in detecting subtle cognitive changes occurring in delirium. The family confusion assessment method (FAM-CAM), is a tool that could support family involvement in the detection of delirium. However, the French version of the FAM-CAM has not yet been validated, which limits its use. The aim of this study is to translate, culturally adapt and validate the French version of the FAM-CAM among a cardiology population.

Who can participate?
Hospitalized patients and their family caregivers (spouse, child, other family, friend), aged 18 or older

What does the study involve?
For participants this study involves completing the translated FAM-CAM (an 11 item questionnaire) at the bedside of their loved one.

What are the possible benefits and risks of participating?
Participants will not derive any personal benefit from their participation in this study. However, the results that are obtained could contribute to the advancement of knowledge in this area. Aside from time spent completing the questionnaire, there are no other anticipated consequences or risks associated with participation.

Where is the study run from?
Montreal Heart Institute (Canada)

When is the study starting and how long is it expected to run for?
June 2018 to June 2019

Who is funding the study?
Montreal Heart Institute Foundation (Canada)

Who is the main contact?
Tanya Mailhot

Trial website

Contact information

Type

Scientific

Primary contact

Miss Tanya Mailhot

ORCID ID

http://orcid.org/0000-0002-3156-4955

Contact details

Montreal Heart Institute
5000 Belanger Street
#S-2490
Montreal
H1T 1C8
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICM 2019-2426

Study information

Scientific title

Evaluation of the psychometric properties of a delirium detection tool completed by families in cardiology

Acronym

Detect_D

Study hypothesis

The trialists performed the translation and cultural adaptation of the FAM-CAM according to the rigorous approach proposed by Sousa and Rojjanasrirat (2011). Following this, the psychometric properties of the French version of FAM-CAM were assessed among hospitalized patients in in cardiovascular care. To do so, the first aim (Aim#1) of this study was to assess the sensitivity and specificity of the French FAM-CAM by contrasting it with the reference standard (medical diagnosis according to DSM-5 criteria). The secondary aim was to assess the sensitivity and specificity of the French FAM-CAM by contrasting it with (Aim#2a) delirium defined from a set of keywords associated with delirium (encephalopathy, confusion, agitation, hallucination, somnolence, haldol [Puelle et al., 2015]) and with (Aim#2b) scores on the Confusion Assessment Method (CAM). The third aim (Aim#3) consisted of assessing the FAMCAM’s predictive value by contrasting it with the reference standard using a ROC curve. Finally, the last aim (Aim#4) was to assess the reliability of the FAM-CAM by contrasting it with the CAM.

Ethics approval

Montreal Heart Institute Ethics Board - approval pending

Study design

Validation study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Delirium

Intervention

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.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The sensitivity and specificity of the French FAM-CAM compared with the reference standard (medical diagnosis according to DSM-5 criteria)

Secondary outcome measures

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

Overall trial start date

15/06/2018

Overall trial end date

15/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

100 family caregivers and patient dyads

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

18/06/2018

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Canada

Trial participating centre

Montreal Heart Institute
Montreal
H1T 1C8
Canada

Sponsor information

Organisation

Montreal Heart Institute Research Center

Sponsor details

5000 Belanger Street
Montreal
H1T 1C8
Canada

Sponsor type

Research organisation

Website

http://www.icm-mhi.org/en/index.html

Funders

Funder type

Charity

Funder name

Montreal Heart Institute Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists do not plan on publishing the study protocol for this study. Planned publication of the study results in a high-impact peer reviewed journal in May 2019.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to policies of the ethics committee.

Intention to publish date

01/05/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/10/2018: The recruitment end date was changed from 03/09/2018 to 31/12/2018.