Social Responsibility Clinical Trial
Official title:
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.
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.
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