Prolonged Grief DisorderBALANCENCT05274841
Systematic Support for Relatives of Palliative Care Patients
A study testing Support of relatives in people with Prolonged Grief Disorder, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The primary purpose of this study is to validate the prognostic screening tool from The Aarhus Bereavement Study (TABS) and to implement a systematic support for relatives of palliative care patients in order to prevent the development of prolonged grief disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Grief Disorder
- What is being tested?
- Support of relatives
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2021to 1 Jan 2025
- 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
- relatives of palliative care patients with relation to Department of Palliative Care, (Rigshospitalet)
- relatives identified by the patient
Who cannot join
- relatives who do not read or understand danish
- relatives who are cognitive disabled
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Julie Høgh Rasmussen
Copenhagen, Vesterbro, 1721
Julie Høgh Rasmussen, Cand.Psych.Aut., +4528707323, julie.hoegh.rasmussen@regionh.dk
Louise Laursen, Cand.Scient.Sand., +4521449323, louise.laursen@regionh.dk
About this study
Official title: Implementation of Systematic Support of Relatives of Palliative Care Patients : a Cohort Study
The primary purpose of this study is to validate the prognostic screening tool from The Aarhus Bereavement Study (TABS) and to implement a systematic support for relatives of palliative care patients in order to prevent the development of prolonged grief disorder. Depending on their identified support needs, the relatives are offered different interventions. It is evaluated whether this procedure of screening and intervening are able to reduce the risk of developing prolonged grief disorder.
Read the detailed description
PRIMARY OUTCOME: identification of the support needs of relatives of palliative care patients
SECONDARY OUTCOME: evaluation of the initiated interventions and whether these are able to reduce the risk of developing prolonged grief disorder
PARTICIPANTS: Relatives (age 18-90) of patients affiliated with specialized palliative care in The Capital Region of Denmark.
The relatives will complete a survey and prognostic screening tool at respectively 2 weeks (T1) and every 6 months (T2) from the time that the patients is affiliated to the specialized palliative care and until the death of the patient. This will happen regardless the status of the patient - that is, whether or not the patient continues being affiliated with specialized palliative care, or the patient is being referred to another palliative care units or doesn't need palliative care anymore.
Furthermore the relatives will complete a follow-up survey and the diagnostic questionnaire PGD-13 at respectively 6 months (T3) and 18 months (T4) after the death of the patient (post loss). It will be evaluated whether there are any diffences in the grief symptoms of relatives of patients with a malign versus non-malign disease. It will also be evaluated whether there is an association between the intervention the relatives received from the palliative care unit at Rigshospital and their grief symptoms post loss.
- Conditions
- Prolonged Grief Disorder
- Being tested
- Support of relatives
- Keywords
- Palliative Care, Screening tool, Assessment tool, Relatives, Support needs, Anticipatory Grief, Palliative patients, Caregivers
- Medical subject headings
- Prolonged Grief Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support of relativesOther
Screening of the support needs of relatives
| Study group | Role | What they receive |
|---|---|---|
| Identified support needs | Other | Identified need of either support from a psychologist, nurse, doctor, socialworker or a combination of theese. Receives: Other: Support of relatives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Support needs of relatives of palliative patients (baseline)
Identification of support needs of relatives assessed by the prognostic screening tool from The Aarhus Bereavement Study (TABS).
Measured: 1 month from the time that the patient is referred to the palliative care team.
Change in Support needs of relatives of palliative patients from baseline
Identification of support needs of relatives assessed by the prognostic screening tool from
Measured: 6 months
Change in Support needs of relatives of palliative patients from baseline
Identification of support needs of relatives assessed by the prognostic screening tool from
Measured: 12 months
Change in Support needs of relatives of palliative patients from baseline
Identification of support needs of relatives assessed by the prognostic screening tool from
Measured: 18 months
Secondary outcomes (2)
Prolonged grief
Symptoms of prolonged grief measured using the Prolonged Grief Disorder - 13 (PG-13, Prigerson et al, 2009). Scores ranging from 11 to 55 are used in the current study, and a higher score indicates a worse outcome. However, there are no officially recommended cut-off scores (Pohlkamp et al, 2018).
Measured: 6 months post-loss.
Prolonged grief
Symptoms of prolonged grief measured using the Prolonged Grief Disorder - 13 (PG-13, Prigerson et al, 2009). Scores ranging from 11 to 55 are used in the current study, and a higher score indicates a worse outcome. However, there are no officially recommended cut-off scores (Pohlkamp et al, 2018).
Measured: 18 months post-loss.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Jan 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Grief DisorderStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Høgh Rasmussen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274841
- Sponsor's protocol ID
- P-2020-429
- Acronym
- BALANCE
- Status last verified
- Mar 2022
- First submitted
- 28 Jan 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Systematic Support of Relatives of Palliative Care Patients : a Cohort Study
- ClinicalTrials.gov ID
- NCT05274841
- Acronym / sponsor ID
- BALANCE / P-2020-429
- Conditions
- Prolonged Grief Disorder
- Keywords
- Palliative Care, Screening tool, Assessment tool, Relatives, Support needs, Anticipatory Grief, Palliative patients, Caregivers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 11 Mar 2022 (actual)
- 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.
The primary purpose of this study is to validate the prognostic screening tool from The Aarhus Bereavement Study (TABS) and to implement a systematic support for relatives of palliative care patients in order to prevent the development of prolonged grief disorder. Depending on their identified support needs, the relatives are offered different interventions. It is evaluated whether this procedure of screening and intervening are able to reduce the risk of developing prolonged grief disorder.
Detailed description
PRIMARY OUTCOME: identification of the support needs of relatives of palliative care patients
SECONDARY OUTCOME: evaluation of the initiated interventions and whether these are able to reduce the risk of developing prolonged grief disorder
PARTICIPANTS: Relatives (age 18-90) of patients affiliated with specialized palliative care in The Capital Region of Denmark.
The relatives will complete a survey and prognostic screening tool at respectively 2 weeks (T1) and every 6 months (T2) from the time that the patients is affiliated to the specialized palliative care and until the death of the patient. This will happen regardless the status of the patient - that is, whether or not the patient continues being affiliated with specialized palliative care, or the patient is being referred to another palliative care units or doesn't need palliative care anymore.
Furthermore the relatives will complete a follow-up survey and the diagnostic questionnaire PGD-13 at respectively 6 months (T3) and 18 months (T4) after the death of the patient (post loss). It will be evaluated whether there are any diffences in the grief symptoms of relatives of patients with a malign versus non-malign disease. It will also be evaluated whether there is an association between the intervention the relatives received from the palliative care unit at Rigshospital and their grief symptoms post loss.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Identified support needs | Other | Other: Support of relativesIdentified need of either support from a psychologist, nurse, doctor, socialworker or a combination of theese. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- relatives of palliative care patients with relation to Department of Palliative Care, (Rigshospitalet)
- relatives identified by the patient
Key exclusion criteria (2 listed)
- relatives who do not read or understand danish
- relatives who are cognitive disabled
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 |
|---|---|---|
| Support of relativesScreening of the support needs of relatives | Other | Identified support needs |
Primary outcome
Support needs of relatives of palliative patients (baseline)
Time frame: 1 month from the time that the patient is referred to the palliative care team.
Identification of support needs of relatives assessed by the prognostic screening tool from The Aarhus Bereavement Study (TABS).
Change in Support needs of relatives of palliative patients from baseline
Time frame: 6 months
Identification of support needs of relatives assessed by the prognostic screening tool from
Change in Support needs of relatives of palliative patients from baseline
Time frame: 12 months
Identification of support needs of relatives assessed by the prognostic screening tool from
Change in Support needs of relatives of palliative patients from baseline
Time frame: 18 months
Identification of support needs of relatives assessed by the prognostic screening tool from
2 secondary outcomes
Prolonged grief
Time frame: 6 months post-loss.
Prolonged grief
Time frame: 18 months post-loss.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support of relatives in people with Prolonged Grief Disorder, run by Copenhagen University Hospital, Rigshospitalet 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 2 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: status not confirmed, as of the sponsor's last update on 11 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Support needs of relatives of palliative patients (baseline) (time frame: 1 month from the time that the patient is referred to the palliative care team.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2022.