Systematic Support for Relatives of Palliative Care Patients (BALANCE)

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.

Study Overview

• Status: Recruiting
• Conditions: Prolonged Grief Disorder
• Intervention / Treatment: Other: Support of relatives

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Vesterbro
    • Copenhagen, Vesterbro, Denmark, 1721
      • Recruiting
      • Julie Høgh Rasmussen
      • Contact: Julie Høgh Rasmussen, Cand.Psych.Aut.; Phone Number: +4528707323; Email: julie.hoegh.rasmussen@regionh.dk
      • Contact: Louise Laursen, Cand.Scient.Sand.; Phone Number: +4521449323; Email: louise.laursen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Identified support needs; Identified need of either support from a psychologist, nurse, doctor, socialworker or a combination of theese.	Other: Support of relatives; Screening of the support needs of relatives

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Palliative Care; Caregivers; Relatives; Screening tool; Support needs; Assessment tool; Anticipatory Grief; Palliative patients
• Other Study ID Numbers: P-2020-429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No