Caregiver Burden and Wellbeing in Relatives of Intensive Care Unit Patients

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2016

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.

Clinical Trial Outcome Measures

Primary Measures

  • Caregiver burden Index score
    • Time Frame: Three months after patients’ discharge from the ICU
    • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Karolinska University Hospital
  • Collaborator
    • Stockholm South General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Peter Sackey, Senior Consultant, Associate Professor – Karolinska University Hospital
  • Overall Official(s)
    • Peter Sackey, MD, PhD, Principal Investigator, Karolinska University Hospital

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