Validation study of a delirium detection tool completed by families
| ISRCTN | ISRCTN56463078 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56463078 |
| Secondary identifying numbers | ICM 2019-2426 |
- Submission date
- 23/05/2018
- Registration date
- 01/06/2018
- Last edited
- 10/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Montreal Heart Institute
5000 Belanger Street, #S-2490
Montreal
H1T 1C8
Canada
 ORCID ID |
0000-0002-3156-4955 |
|---|
Study information
| Study design | Validation study |
|---|---|
| Primary study design | Observational |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation of the psychometric properties of a delirium detection tool completed by families in cardiology |
| Study acronym | Detect_D |
| Study objectives | 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(s) | Montreal Heart Institute Ethics Board - approval pending |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/06/2018 |
| Completion date | 15/06/2019 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 family caregivers and patient dyads |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 18/06/2018 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- Canada
Study participating centre
H1T 1C8
Canada
Sponsor information
Research organisation
5000 Belanger Street
Montreal
H1T 1C8
Canada
| Website | http://www.icm-mhi.org/en/index.html |
|---|---|
"ROR" |
https://ror.org/03vs03g62 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Editorial Notes
10/01/2019: The following changes have been made:
1. The recruitment end date has been updated from 31/12/2018 to 01/03/2019.
2. The intention to publish date has been updated from 01/05/2019 to 15/06/2020.
12/10/2018: The recruitment end date was changed from 03/09/2018 to 31/12/2018.
