NCT01292512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2012

Enrollment Period

2.6 years

First QC Date

February 8, 2011

Last Update Submit

March 25, 2020

Conditions

Keywords

Bereavement managementComplicated grief

Outcome Measures

Primary Outcomes (1)

  • Effect of the intervention measured by an increase in the diagnosis of complicated grief.

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

    20 months

Secondary Outcomes (1)

  • Effect of the intervention measured by register-based data.

    20 months

Study Arms (2)

Intervention group

EXPERIMENTAL

A) Professional level. B) Patient level. Intervention Professional level: General Practitioners (GP) receive updated information on bereavement related symptoms, how to identify complicated grief, and the Dual Process Model (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

Control group

OTHER

Treatment as usual (in the Danish health care system).

Other: Prognostic screening for complicated grief

Interventions

Patients in the intervention group are prognostically screened for development of complicated grief to identify those in need of help.

Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older.
  • Danish citizen.
  • Able to understand and speak Danish.
  • Informed consent.
  • Mentally able to cooperate

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for General Practice

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Guldin MB, Vedsted P, Jensen AB, Olesen F, Zachariae R. Bereavement care in general practice: a cluster-randomized clinical trial. Fam Pract. 2013 Apr;30(2):134-41. doi: 10.1093/fampra/cms053. Epub 2012 Sep 10.

Study Officials

  • Frede Olesen, Professor

    Research Unit for General Practice, Aarhus University, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2011

First Posted

February 9, 2011

Study Start

June 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 27, 2020

Record last verified: 2012-03

Locations