Psychological Distress in Relatives of Severely Injured Patients

NCT03137420 | Unknown

• 1 other identifier: 2017-00074
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who have sustained and survived a polytrauma do heavily depend on the support and functioning of their family. This is only possible if the family members are physically and mentally able to cope with the situation. It is the investigators' hypothesis that the true percentage of polytrauma patients' relatives suffering under relevant psychological distress is higher than commonly assumed. The investigators conduct a prospective cohort study where we follow up on a cohort of patients and their relatives over 1 year after trauma - one group with severely injured patients (case) and one group with minor musculo-skeletal injuries (control). In order to assess the influence of the patients' disability and their own psychological distress on the psychological distress of the relatives, the investigators also collect corresponding data from the patients themselves. In order to assess the influence of the trauma itself, the investigators compare a group of multiple injured patients and their relatives with a group of patients with isolated musculoskeletal injuries and their relatives. In addition, the investigators record the ISS of each patient. In order to investigate the changes in relatives' distress over time and to find out more about potential risk factors or con-founders it is necessary to conduct a prospective study.

Conditions

Polytrauma; Psychological Distress; Relatives

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale (HADS)

  Questionnaire on anxiety and depression

  12 months

Secondary Outcomes (2)

• Brief Family Distress Scale (BFDS)

  12 months

• Numeric Scale of Family Distress (NSFD)

  12 months

Study Arms (2)

Severely injured patients and their relatives

Severely injured patients (ISS \> 16) and their relatives. Relatives are defined as on of the following: spouse/partner, son/daughter, parent, sibling, cousin.

Diagnostic Test: Numeric Scale of Family Distress

Monotrauma patients and theri relatives

Patients with isolated non-life threatening musculo-skeletal injuries and their relatives (control). Relatives are defined as on of the following: spouse/partner, son/daughter, parent, sibling, cousin.

Diagnostic Test: Numeric Scale of Family Distress

Interventions

Numeric Scale of Family Distress DIAGNOSTIC_TEST

Questionnaires at 1, 3, 6 and 12 months

Also known as: Hospital Anxiety and Depression Scale, Brief Family Distress Scale

Monotrauma patients and theri relatives; Severely injured patients and their relatives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 prospective severely injured patients and their relatives (cases) and 50 prospective patients with isolated non-life threatening musculo-skeletal injuries and their relatives (control).

You may qualify if:

• age ≥ 18 years
• Severely injured patients and their relatives (ISS \> 16) orpatients with isolated non-life threatening musculo-skeletal injuries and their relatives (control). Relatives are defined as on of the following: spouse/partner, son/daughter, parent, sibling, cousin.
• patients admitted to the Klinik für Traumatologie, UniversitätsSpital Zürich, during the years 2017/18 and their relatives (control)

You may not qualify if:

• Patients who are still in a life-threatening situation and their relatives
• Patients and relatives without signed informed consent
• Participants with cognitive disabilities not allowing to complete the questionnaires or to give informed consent (their relatives can still be included as the relatives of disabled patients most likely suffer under pronounced distress)
• Participants that are able to read and understand German language

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Division of Trauma Surgery, University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Georg Osterhoff, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georg Osterhoff, MD

CONTACT

+41 44 255 1111; georg.osterhoff@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 2, 2017
• Study Start: April 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: November 1, 2019
• Last Updated: October 31, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)