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Bereavement Management - Description, Assessment and Care

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ClinicalTrials.gov Identifier: NCT01292512
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : March 12, 2012
Sponsor:
Collaborators:
Dæhnfeldt Foundation
TrygFonden, Denmark
Danish Cancer Society
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
This study aims to develop a risk assessment tool to identify bereaved in risk of complicated grief reactions and to implement a bereavement management programme in primary health care based on the Dual Process Model of coping with bereavement. Furthermore to enhance bereavement care in general practice and to enhance patients' self-management in bereavement care.

Condition or disease Intervention/treatment Phase
Bereavement Grief Other: Prognostic screening for complicated grief Not Applicable

Detailed Description:
In Denmark alone there are approximately 55.000 deaths annually which leave approximately 200.000 bereaved close relatives. International studies show that 10-15% of bereaved persons develop complications following the death of a close relative. If those studies hold true, approximately 20 - 30.000 individuals annually will develop complications as a result of suffering a loss, and there is hardly any knowledge of how bereavement is treated or even legitimized in primary care and referred on to specialized (psychological or psychiatric) care. The field of bereavement is in need of studies that validate the theoretical underpinnings of the research area, enhanced assessment of predictive risk factors and updated intervention methods: in short a scientifically valid management programme.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Bereavement Management. Description, Assessment and Care. A Randomized Controlled Study.
Study Start Date : June 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Interventiongroup

A) Professional level. B) Patient level.

Intervention

Professional level:

GPs receive updated information on bereavement related symptoms, how to identify complicated grief, and the DPM of coping.

GPs receive suggestions on how to provide psycho-educational support for the patient.

GPs are informed about the results of the initial assessment of their patient prognostic screening for complicated grief.

Patient level:

Patients receive updated information on bereavement related symptoms, the DPM of coping and suggestions on when to seek professional help.

Patients are informed of the results of their initial assessment of their prognostic grief screening.

Patients are encouraged to contact their GP if they worry about handling their bereavement reaction.

Other: Prognostic screening for complicated grief
Patients in the intervention group are prognostically screened for development of complicated grief to identify those in need of help.
No Intervention: Control group
Treatment as usual (in the Danish health care system).
Other: Prognostic screening for complicated grief
Patients in the intervention group are prognostically screened for development of complicated grief to identify those in need of help.



Primary Outcome Measures :
  1. Effect of the intervention measured by an increase in the diagnosis of complicated grief. [ Time Frame: 20 months ]
    GPs receive updated information on bereavement related symptoms, how to identify complicated grief, and the Dual Process Model of coping.


Secondary Outcome Measures :
  1. Effect of the intervention measured by register-based data. [ Time Frame: 20 months ]
    Effect of the intervention measured by register-based data on frequency in contact with GP, referrals to psychological/psychiatric counselling, medicine consumption and use of emergency services.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly bereaved from one of the inclusion facilities.
  • 18 years or older.
  • Danish citizen.
  • Able to understand and speak Danish.
  • Informed consent.
  • Mentally able to cooperate

Exclusion Criteria:

  • Patients with known substance abuse.
  • Patients with recently (within 5 years) diagnosed psychopathological disorders that trigger psychotic episodes.

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): NCT01292512


Locations
Denmark
Research Unit for General Practice
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Dæhnfeldt Foundation
TrygFonden, Denmark
Danish Cancer Society
Investigators
Study Chair: Frede Olesen, Professor Research Unit for General Practice, Aarhus University, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01292512     History of Changes
Other Study ID Numbers: Bereavement Management.
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012

Keywords provided by University of Aarhus:
Bereavement management
Complicated grief