BereavementNCT01292512
Bereavement Management - Description, Assessment and Care
A study testing Prognostic screening for complicated grief in people with Bereavement and Grief, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bereavement, Grief
- What is being tested?
- Prognostic screening for complicated grief
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with known substance abuse.
- Patients with recently (within 5 years) diagnosed psychopathological disorders that trigger psychotic episodes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bereavement Management. Description, Assessment and Care. A Randomized Controlled Study.
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.
Read the 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.
- Conditions
- Bereavement, Grief
- Being tested
- Prognostic screening for complicated grief
- Keywords
- Bereavement management, Complicated grief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognostic screening for complicated griefOther
Patients in the intervention group are prognostically screened for development of complicated grief to identify those in need of help.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Prognostic screening for complicated grief |
| Control group | Other | Treatment as usual (in the Danish health care system). Receives: Other: Prognostic screening for complicated grief |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 months
Secondary outcomes (1)
Effect of the intervention measured by register-based data.
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.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJun 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BereavementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Dæhnfeldt Foundation, TrygFonden, Denmark, Danish Cancer Society
- Responsible party
- Sponsor
- Investigators
- Frede Olesen, Professor, Study chair, Research Unit for General Practice, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292512
- Sponsor's protocol ID
- Bereavement Management.
- Status last verified
- Mar 2012
- First submitted
- 8 Feb 2011
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22964078
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bereavement Management. Description, Assessment and Care. A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT01292512
- Acronym / sponsor ID
- Bereavement Management.
- Conditions
- Bereavement, Grief
- Keywords
- Bereavement management, Complicated grief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Dæhnfeldt Foundation, TrygFonden, Denmark, Danish Cancer Society
- Study start
- Jun 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Prognostic screening for complicated griefA) 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. |
| Control group | Other | Other: Prognostic screening for complicated griefTreatment as usual (in the Danish health care system). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly bereaved from one of the inclusion facilities.
- 18 years or older.
- Danish citizen.
- Able to understand and speak Danish.
- Informed consent.
Key exclusion criteria (2 listed)
- Patients with known substance abuse.
- Patients with recently (within 5 years) diagnosed psychopathological disorders that trigger psychotic episodes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prognostic screening for complicated griefPatients in the intervention group are prognostically screened for development of complicated grief to identify those in need of help. | Other | Control group, Intervention group |
Primary outcome
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.
1 secondary outcome
Effect of the intervention measured by register-based data.
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Derived from this study: PubMed 22964078Guldin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frede Olesen, Professor study chair
Research Unit for General Practice, Aarhus University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prognostic screening for complicated grief in people with Bereavement and Grief, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the intervention measured by an increase in the diagnosis of complicated grief. (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01292512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.