Clinical trial NCT02712541: Caregiver Burden and Wellbeing in Relatives of Intensive Care Unit Patients
Official title: Caregiver Burden and Wellbeing in Relatives of Intensive Care Unit Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Responsibility
Keywords: Caregiver burden Index
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
name: Uppsala University Hospital
name: Region Örebro County
First posted: 2016-03-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Relative living together with a patient included in the study PROGRESS-ICU.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver burden Index score
timeFrame: Three months after patients' discharge from the ICU
Secondary outcomes:
measure: Short Form-36
timeFrame: Three months after patients' ICU discharge
measure: Hospital Anxiety and Depression Scale
timeFrame: Three months post ICU discharge
measure: Posttraumatic stress symptoms Inventory - 14
timeFrame: Three months post ICU discharge
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Stockholm South Hospital
city: Uppsala
country: Sweden
facility: Dept of Anesthesia and Intensive Care, Uppsala Akademiska
city: Örebro
country: Sweden
facility: Örebro Universitetssjukhus
Study officials:
affiliation: Karolinska University Hospital
name: Peter Sackey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: