Caregiver Burden and Wellbeing in Relatives of Intensive Care Unit Patients

Social Responsibility Clinical Trial

Official title:

Caregiver Burden and Wellbeing in Relatives of Intensive Care Unit Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712541
• Other study ID #: EPN Dnr 2015/1799-31 (b)
• Status: Completed
• Phase: N/A
• First received: February 5, 2016
• Last updated: February 12, 2018
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: February 2018
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Social Responsibility

Locations

Country	Name	City	State
Sweden	Örebro Universitetssjukhus	Örebro
Sweden	Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital	Stockholm
Sweden	Stockholm South Hospital	Stockholm
Sweden	Dept of Anesthesia and Intensive Care, Uppsala Akademiska	Uppsala

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska University Hospital	Region Örebro County, Stockholm South General Hospital, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

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