Caregiver Burden and Wellbeing in Relatives of Intensive Care Unit Patients

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.

Study Overview

• Status: Completed
• Conditions: Social Responsibility

Detailed Description

This is a sub-study to the multicenter "PROGRESS study". Details of the PROGRESS study have been described elsewhere. Briefly, an observational study including 600-1000 adult ICU patients from ten European hospitals will be followed up during three months to identify potential risk factors for physical and psychological problems.

The sub-study is conducted in four Swedish hospitals (Karolinska University Hospital Solna, Södersjukhuset, Stockholm, Örebro University Hospital and Akademiska University Hospital in Uppsala). Relatives to patients included in the PROGRESS study, who give informed consent to participate are consecutively included in the study.

Consenting participants (relatives) will be approached after inclusion of the patient and asked to estimate their own health related quality of life (HRQOL) 2 weeks prior to the time point for patient ICU admission through a HRQOL questionnaire. This self-reported HRQOL data will be used as proxy for baseline data. Three months after ICU discharge, relatives to ICU survivors will receive the following questionnaires by postal mail; Caregiver Burden Index, HRQOL questionnaire, a questionnaire screening for symptoms of anxiety and depression and a questionnaire screening for symptoms of posttraumatic stress.

The relatives will also be asked to state the number of working days lost due to caretaking of the ICU survivor.

ICU survivors' physical and psychological outcome, assessed with BI, SF-36, PTSS-14 and HADS three months after ICU discharge, obtained in the main PROGRESS study, will be compared with relatives' reported caregiver burden.

Secondary outcomes are associations between caregiver burden and reported health-related quality of life between baseline and 3 months after ICU discharge, frequency of symptoms of anxiety, depression and posttraumatic stress 3 months post ICU discharge and number of working days lost because of their relative's critical illness.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Stockholm South Hospital
  • Stockholm, Sweden, 171 76
    • Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital
  • Uppsala, Sweden
    • Dept of Anesthesia and Intensive Care, Uppsala Akademiska
  • Örebro, Sweden
    • Örebro Universitetssjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. 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

Exclusion Criteria:

1. Non-Swedish-speaking
2. Overt or documented cognitive impairment

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form-36	Relation between Caregiver burden Index scores and mental component score in SF-36	Three months after patients' ICU discharge
Hospital Anxiety and Depression Scale	Relation between outcomes in patients and scores in nearest of kin	Three months post ICU discharge
Posttraumatic stress symptoms Inventory - 14	Relation between patients outcome and nearest of kin scores	Three months post ICU discharge

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Region Örebro County; Uppsala University Hospital; Stockholm South General Hospital
• Investigators: Principal Investigator: Peter Sackey, MD, PhD, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Caregiver burden Index
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: EPN Dnr 2015/1799-31 (b)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED