Bereavement Management - Description, Assessment and Care

This study has been completed.
Sponsor:
Collaborators:
Dæhnfeldt Foundation
TrygFonden, Denmark
Kræftens Bekæmpelse
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01292512
First received: February 8, 2011
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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 Intervention
Bereavement
Grief
Other: Prognostic screening for complicated grief

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Bereavement Management. Description, Assessment and Care. A Randomized Controlled Study.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Effect of the intervention measured by an increase in the diagnosis of complicated grief. [ Time Frame: 20 months ] [ Designated as safety issue: No ]
    GPs receive updated information on bereavement related symptoms, how to identify complicated grief, and the Dual Process Model of coping.


Secondary Outcome Measures:
  • Effect of the intervention measured by register-based data. [ Time Frame: 20 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 402
Study Start Date: June 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292512

Locations
Denmark
Research Unit for General Practice
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Dæhnfeldt Foundation
TrygFonden, Denmark
Kræftens Bekæmpelse
Investigators
Study Chair: Frede Olesen, Professor Research Unit for General Practice, Aarhus University, Denmark
  More Information

No publications provided by University of Aarhus

Additional 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.
Study First Received: February 8, 2011
Last Updated: March 9, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Bereavement management
Complicated grief

ClinicalTrials.gov processed this record on October 19, 2014