NCT05274841

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

4 years

First QC Date

January 28, 2022

Last Update Submit

March 8, 2022

Conditions

Prolonged Grief Disorder

Keywords

Palliative CareScreening toolAssessment toolRelativesSupport needsAnticipatory GriefPalliative patientsCaregivers

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Prolonged grief

    6 months post-loss.

  • Prolonged grief

    18 months post-loss.

Study Arms (1)

Identified support needs

OTHER

Identified need of either support from a psychologist, nurse, doctor, socialworker or a combination of theese.

Other: Support of relatives

Interventions

Support of relativesOTHER

Screening of the support needs of relatives

Identified support needs

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • relatives who do not read or understand danish
  • relatives who are cognitive disabled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julie Høgh Rasmussen

Copenhagen, Vesterbro, 1721, Denmark

RECRUITING

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

January 28, 2022

First Posted

March 11, 2022

Study Start

January 1, 2021

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

March 11, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)