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NCT03405766 Clinical Trial

Barriers in the Process of Achieving Informed Consent From Critically Ill Patients

Critically Ill Clinical Trial

Official title:
Barriers in the Process of Achieving Informed Consent From Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03405766
Other study ID # REK 2017/1254
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2018
Est. completion date November 20, 2018

Study information
Verified date November 2018
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study will explore barriers in the process of achieving informed consent from critically ill patients

Description:

The barriers will be divided into four major categories:

- Practical barriers

- Medical barriers

- Legal barriers

- Ethical barriers

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date November 20, 2018
Est. primary completion date November 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients considered for inclusion in the NORIDES study

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (3)
Lead Sponsor Collaborator
Oslo University Hospital University Hospital, Akershus, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Study recruitment barriers, Medical Number (%) of patients unable to give consent or to sign 2018-2022
Primary Study recruitment barriers, Ethical Number (%) of patients not asked to give consent due to ethical issues 2018-2022
Secondary Study recruitment barriers, Practical Number (%) of cases where practical reasons made consent impossible 2018-2022
Secondary Study recruitment barriers, Legal Number (%) of patients where legal issues made consent impossible 2018-2022
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