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Trial record 13 of 562 for:    Recruiting, Not yet recruiting Studies | Psychiatric Problem

Psychological Distress in Relatives of Severely Injured Patients

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ClinicalTrials.gov Identifier: NCT03137420
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.


Condition or disease Intervention/treatment
Polytrauma Psychological Distress Relatives Diagnostic Test: Numeric Scale of Family Distress

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychological Distress in Relatives of Severely Injured Patients
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
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
Questionnaires at 1, 3, 6 and 12 months
Other Names:
  • Hospital Anxiety and Depression Scale
  • Brief Family Distress Scale

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
Questionnaires at 1, 3, 6 and 12 months
Other Names:
  • Hospital Anxiety and Depression Scale
  • Brief Family Distress Scale




Primary Outcome Measures :
  1. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 months ]
    Questionnaire on anxiety and depression


Secondary Outcome Measures :
  1. Brief Family Distress Scale (BFDS) [ Time Frame: 12 months ]
    Questionnaire on subjective distress in a family

  2. Numeric Scale of Family Distress (NSFD) [ Time Frame: 12 months ]
    Scale from 0 to 10



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137420


Contacts
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Contact: Georg Osterhoff, MD +41 44 255 1111 georg.osterhoff@usz.ch

Locations
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Switzerland
Division of Trauma Surgery, University Hospital Zurich Recruiting
Zürich, Switzerland, 8091
Contact: Georg Osterhoff, MD    +41 44 255 1111    georg.osterhoff@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Georg Osterhoff, MD University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03137420    
Other Study ID Numbers: 2017-00074
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Trauma
Wounds and Injuries