Health and Quality of Life One Year After Discharge From... | NCT02671916

Studies
Health and Quality of Life One Year After Discharge From the Intensive Care Unit (ICU)

NCT02671916

Sponsor

Prof. Dr. med. Cristoph Haberthür

Status

Terminated

Last Update Posted

Mar 6, 2019Actual

Enrollment

55Actual

Phase

Not provided

Conditions

Critically Ill

Interventions

questionnaire

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient number of replies by patients

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Aug 17, 2015

First Submission Date that Met QC Criteria

Jan 29, 2016

First Posted Date

Feb 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2019

Last Update Posted Date

Mar 6, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. med. Cristoph Haberthür, Prof. Dr. med., Klinik Hirslanden, ZurichSponsor-Investigator

Lead Sponsor

Prof. Dr. med. Cristoph HaberthürOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal is to capture the Quality of life and survival of patients one year after the stay at ICU. Data will be collected during the stay in the ICU and evaluated. One year after the ICU stay patients will be send a Quality of Life questionnaire they need to fill out and return. All data will be evaluated together.

Detailed Description

no detailled description necessary

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
all patients		questionnaire for patients with ICU stay at least 5 days or longer without interruption at the ICU	Behavioral: questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Behavioral	Investigation on all study patients, no Intervention, no groups	all patients

Measure	Description	Time Frame
Survival		1 year after ICU discharge

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who are at least 5 days or longer without interruption at the ICU

Exclusion Criteria:

patients with less than 4 days at the ICU

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all patients with conditions that lead to an ICU stay

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christoph Haberthür, MD	Klinik Hirslanden, Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik Hirslanden		Zurich	Canton of Zurich	8032	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided