Critical IllnessNCT02686970
Spanish Adaptation and Study of Reliability of the European Quality Questionnaire (EuroQ2)
An observational study of Critical Illness, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 132 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2016to 1 May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Family member or person responsible for patient decision making in the ICU
Who may be able to join
- 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.
Who cannot join
- Family members younger than 18 years,
- Family members not able to read or write Spanish
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Critical Illness
- Keywords
- Family, Quality, Validate, ICU
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
European Quality Questionnaire (euroq2)
Opinions about Quality of care of ICU after the stay
Measured: 48 h after discharge of patients alive from ICU or 1 month after the death into ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study start15 Nov 2016
- Primary completion1 May 2017
- Study completion1 May 2017
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 Critical IllnessStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisca Pérez-López, Corporacion Parc Tauli
- Investigators
- Francisca Pérez-López, RN, MSc, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686970
- Sponsor's protocol ID
- CorporationPT
- Status last verified
- May 2017
- First submitted
- 18 Jan 2016
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 26169545Gerritsen 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.
PubMed 22878897
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Adaptation and Study of Reliability of the European Quality Questionnaire (EuroQ2)
- ClinicalTrials.gov ID
- NCT02686970
- Acronym / sponsor ID
- CorporationPT
- Conditions
- Critical Illness
- Keywords
- Family, Quality, Validate, ICU
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 22 Feb 2016 (estimated)
- 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Family member or person responsible for patient decision making in the ICU
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Family members younger than 18 years,
- Family members not able to read or write Spanish
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
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Background: PubMed 26169545Jensen 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.
- Results publication: PubMed 22878897Gerritsen 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.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Francisca Pérez-López, RN, MSc principal investigator
Corporacion Parc Tauli
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 Critical Illness, run by Corporacion Parc Tauli at 1 site in Spain.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 Feb 2019. 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 Spain. 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 was stopped early. Results are not available in the source record.
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?
European Quality Questionnaire (euroq2) (time frame: 48 h after discharge of patients alive from ICU or 1 month after the death into ICU). 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 NCT02686970, 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 7 Feb 2019.