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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02686970
Other study ID # CorporationPT
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 15, 2016
Est. completion date May 1, 2017

Study information

Verified date May 2017
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 132
Est. completion date May 1, 2017
Est. primary completion date May 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Corporacion Parc Taulí Sabadell Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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): — View Citation

Jensen HI, Gerritsen RT, Koopmans M, Zijlstra JG, Curtis JR, Ørding 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary European Quality Questionnaire (euroq2) 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
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