NCT03405766

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
Last Updated

November 30, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

December 13, 2017

Last Update Submit

November 29, 2018

Conditions

Critically IllEthicsInformed ConsentStudy Recruitment

Outcome Measures

Primary Outcomes (2)

  • Study recruitment barriers, Medical

    Number (%) of patients unable to give consent or to sign

    2018-2022

  • Study recruitment barriers, Ethical

    Number (%) of patients not asked to give consent due to ethical issues

    2018-2022

Secondary Outcomes (2)

  • Study recruitment barriers, Practical

    2018-2022

  • Study recruitment barriers, Legal

    2018-2022

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Intensive care unit patients

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0540, Norway

Location

Related Publications (1)

  • Dahlberg J, Eriksen C, Robertsen A, Beitland S. Barriers and challenges in the process of including critically ill patients in clinical studies. Scand J Trauma Resusc Emerg Med. 2020 Jun 8;28(1):51. doi: 10.1186/s13049-020-00732-x.

    PMID: 32513204DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 13, 2017

First Posted

January 23, 2018

Study Start

May 2, 2018

Primary Completion

November 20, 2018

Study Completion

November 20, 2018

Last Updated

November 30, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Not planned to share data

Locations

NO(1)