- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02686970
Spanish Adaptation and Study of Reliability of the European Quality Questionnaire (EuroQ2)
February 6, 2019 updated by: Francisca Pérez-López, Corporacion Parc Tauli
The aim of this study is to adapt and validate to the Spanish the European Quality Questionnaire (EuroQ2) to evaluate families' experiences of quality of care for critically ill and dying patients in the ICU.
Study Overview
Status
Terminated
Conditions
Detailed Description
The aim of this study is to adapt and validate a Spanish-language version of the European Quality Questionnaire (EuroQ2).
Using a forward-backward translation methodology, we will translate the EuroQ2 into Spanish and will evaluate its psychometric characteristics in a clinical sample of 200 family members responsible for making medical decisions for patients who are discharged from the ICU or who died in the ICU.
Cronbach's alpha values, confirmatory factor analysis (CFA) will be evaluated in order to know the reliability, construct validity, and convergent validity.
Study Type
Observational
Enrollment (Actual)
132
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Barcelona
-
Sabadell, Barcelona, Spain, 08208
- Corporacion Parc Tauli
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Family member or person responsible for patient decision making in the ICU
Description
Inclusion Criteria:
- Family members of patients admitted to the ICU for 48 hours or more.
- Family members responsible for patient decision making in the ICU who consent participate.
Exclusion Criteria:
- Family members younger than 18 years,
- Family members not able to read or write Spanish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
European Quality Questionnaire (euroq2)
Time Frame: 48 h after discharge of patients alive from ICU or 1 month after the death into ICU
|
Opinions about Quality of care of ICU after the stay
|
48 h after discharge of patients alive from ICU or 1 month after the death into ICU
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francisca Pérez-López, RN, MSc, Corporacion Parc Tauli
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jensen HI, Gerritsen RT, Koopmans M, Zijlstra JG, Curtis JR, Ording H. Families' experiences of intensive care unit quality of care: Development and validation of a European questionnaire (euroQ2). J Crit Care. 2015 Oct;30(5):884-90. doi: 10.1016/j.jcrc.2015.06.004. Epub 2015 Jun 16.
- Gerritsen RT, Hofhuis JGM, Koopmans M, van der Woude M, Bormans L, Hovingh A, Spronk PE. Perception by family members and ICU staff of the quality of dying and death in the ICU: a prospective multicenter study in The Netherlands. Chest. 2013 Feb 1;143(2):357-363. doi: 10.1378/chest.12-0569.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2016
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
January 18, 2016
First Submitted That Met QC Criteria
February 16, 2016
First Posted (Estimate)
February 22, 2016
Study Record Updates
Last Update Posted (Actual)
February 7, 2019
Last Update Submitted That Met QC Criteria
February 6, 2019
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CorporationPT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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