NCT02712541

Brief Summary

The purpose of this study is to determine whether there is an association between adverse physical and/or psychological outcome in ICU survivors and the caregiver burden for their relatives. We hypothesize that relatives to ICU survivors with an incomplete physical and/or psychological recovery three months after ICU stay report a higher caregiver burden.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

February 5, 2016

Last Update Submit

February 12, 2018

Conditions

Social Responsibility

Keywords

Caregiver burden Index

Outcome Measures

Primary Outcomes (1)

  • Caregiver burden Index score

    Score compared between nearest of kin to patients with good or poor physical or psychological outcome (obtained in the main PROGRESS-ICU Study), three months after ICU discharge

    Three months after patients' discharge from the ICU

Secondary Outcomes (3)

  • Short Form-36

    Three months after patients' ICU discharge

  • Hospital Anxiety and Depression Scale

    Three months post ICU discharge

  • Posttraumatic stress symptoms Inventory - 14

    Three months post ICU discharge

Eligibility Criteria

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

Relative living together with a patient included in the study PROGRESS-ICU.

You may qualify if:

  • \. Relatives are considered eligible if they are a) partner to the patient b) adult children, siblings, parents or close friend that share household with the ICU survivor

You may not qualify if:

  • Non-Swedish-speaking
  • Overt or documented cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Örebro Universitetssjukhus

Örebro, Sweden

Location

Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Stockholm South Hospital

Stockholm, Sweden

Location

Dept of Anesthesia and Intensive Care, Uppsala Akademiska

Uppsala, Sweden

Location

Study Officials

  • Peter Sackey, MD, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, Associate Professor

Study Record Dates

First Submitted

February 5, 2016

First Posted

March 18, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

SE(4)