Systematic Support for Relatives of Palliative Care Patients

Prolonged Grief Disorder Clinical Trial

— BALANCE  

Official title:

Implementation of Systematic Support of Relatives of Palliative Care Patients : a Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05274841
• Other study ID #: P-2020-429
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• relatives of palliative care patients with relation to Department of Palliative Care, (Rigshospitalet)

• relatives identified by the patient

Exclusion Criteria:

• relatives who do not read or understand danish

• relatives who are cognitive disabled

Related Conditions & MeSH terms

• Prolonged Grief Disorder

Intervention

Other:
• Support of relatives
Screening of the support needs of relatives

Locations

Country	Name	City	State
Denmark	Julie Høgh Rasmussen	Copenhagen	Vesterbro

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 month from the time that the patient is referred to the palliative care team.
Primary	Change in Support needs of relatives of palliative patients from baseline	Identification of support needs of relatives assessed by the prognostic screening tool from	6 months
Primary	Change in Support needs of relatives of palliative patients from baseline	Identification of support needs of relatives assessed by the prognostic screening tool from	12 months
Primary	Change in Support needs of relatives of palliative patients from baseline	Identification of support needs of relatives assessed by the prognostic screening tool from	18 months
Secondary	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).	6 months post-loss.
Secondary	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).	18 months post-loss.