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Completed

NCT Number: NCT02712541

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.

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Key information

Conditions

Social Responsibility

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Stockholm, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Non-Swedish-speaking
  • Overt or documented cognitive impairment

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Short Form-36

    Time frame: Three months after patients' ICU discharge

    Relation between Caregiver burden Index scores and mental component score in SF-36

  2. Hospital Anxiety and Depression Scale

    Time frame: Three months post ICU discharge

    Relation between outcomes in patients and scores in nearest of kin

  3. Posttraumatic stress symptoms Inventory - 14

    Time frame: Three months post ICU discharge

    Relation between patients outcome and nearest of kin scores

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Region Örebro County
  • Stockholm South General Hospital
  • Uppsala University Hospital

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2016
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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