Improvement of Support to Caregivers of Patients in Specialized Palliative Care at Home

NCT ID: NCT03466580

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

466 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2019-12-31

Brief Summary

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The aim of the project is to evaluate the use of the caregiver-led 'CSNAT intervention' to identify, prioritize and address support needs among caregivers of patients who are starting in specialized palliative care at home in Denmark

Detailed Description

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Conditions

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Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A stepped wedge cluster randomized controlled trial. All clusters (i.e., specialized palliative care (SPC) units) will start as controls and will change to intervention at various times determined by randomization. In this way, all SPC units will contribute to control and intervention groups, thus accounting for variation between SPC units.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

('Standard' specialized palliative care +) The Carer Support Needs Assessment Tool (CSNAT) intervention.

Group Type EXPERIMENTAL

The Carer Support Needs Assessment Tool (CSNAT) intervention

Intervention Type BEHAVIORAL

The CSNAT intervention is a caregiver-led approach where the caregiver first identifies his/her needs of support in the CSNAT, which consists of 14 support domains. Then the practitioner facilitates the intervention where the caregiver prioritizes which domains to discuss. In the conversation, the caregiver's domain priorities and subsequently identified support needs are discussed with the practitioner to agree on actions/solutions and a shared action plan. The intervention will be offered each caregiver twice: the first time between 0 and 13 days after enrollment, and the second time between 15 and 27 days after enrollment.

Control

('Standard' specialized palliative care). No intervention offered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The Carer Support Needs Assessment Tool (CSNAT) intervention

The CSNAT intervention is a caregiver-led approach where the caregiver first identifies his/her needs of support in the CSNAT, which consists of 14 support domains. Then the practitioner facilitates the intervention where the caregiver prioritizes which domains to discuss. In the conversation, the caregiver's domain priorities and subsequently identified support needs are discussed with the practitioner to agree on actions/solutions and a shared action plan. The intervention will be offered each caregiver twice: the first time between 0 and 13 days after enrollment, and the second time between 15 and 27 days after enrollment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* The caregiver and patient should be able to read and understand Danish
* The caregiver and patient should give written informed consent
* The patient should be newly referred to specialized palliative care (SPC) in the SPC unit.

Exclusion Criteria

* The caregiver is viewed by the practitioners as being too distressed to be asked about participation
* The caregiver has a known cognitive impairment precluding participation (based on the practitioners' clinical judgement)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

The A.P. Moeller Foundation

UNKNOWN

Sponsor Role collaborator

The Palliative Unit, Amager-Hvidovre Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Arresoedal Hospice

UNKNOWN

Sponsor Role collaborator

Diakonissestiftelsens Hospice

UNKNOWN

Sponsor Role collaborator

Hospice Soendergaard

UNKNOWN

Sponsor Role collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role collaborator

The Palliative Team NORTH, University Hospital Sjaelland

OTHER

Sponsor Role collaborator

Soenderjylland Hospital

UNKNOWN

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mogens Groenvold

Professor, DMSc, PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mogens Groenvold, DMSc PhD MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Department of Palliative Medicine, Bispebjerg Hospital

Copenhagen NV, , Denmark

Site Status

The Palliative unit, Rigshospitalet

Copenhagen O, , Denmark

Site Status

Diakonissestiftelsens Hospice

Frederiksberg, , Denmark

Site Status

The Palliative Unit, Nordsjaellands Hospital

Frederikssund, , Denmark

Site Status

Arresoedal Hospice

Frederiksværk, , Denmark

Site Status

The Palliative Unit, Amager-Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Hospice Soendergaard

Maaloev, , Denmark

Site Status

Palliative Team Fyn, OUH

Odense C, , Denmark

Site Status

The Palliative Team NORTH, University Hospital Sjaelland

Roskilde, , Denmark

Site Status

Palliative Team, Hospital Soenderjylland

Sønderborg, , Denmark

Site Status

Countries

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Denmark

References

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Lund L, Ross L, Petersen MA, Rosted E, Bollig G, Juhl GI, Farholt H, Winther H, Laursen L, Blaaberg EG, Weensgaard S, Guldin MB, Ewing G, Grande G, Groenvold M. Process, content, and experiences of delivering the Carer Support Needs Assessment Tool Intervention (CSNAT-I) in the Danish specialised palliative care setting. Support Care Cancer. 2022 Jan;30(1):377-387. doi: 10.1007/s00520-021-06432-1. Epub 2021 Jul 23.

Reference Type DERIVED
PMID: 34296334 (View on PubMed)

Lund L, Ross L, Petersen MA, Blach A, Rosted E, Bollig G, Juhl GI, Farholt HB, Winther H, Laursen L, Hasse M, Weensgaard S, Guldin MB, Ewing G, Grande G, Groenvold M. Effect of the Carer Support Needs Assessment Tool intervention (CSNAT-I) in the Danish specialised palliative care setting: a stepped-wedge cluster randomised controlled trial. BMJ Support Palliat Care. 2020 Oct 28:bmjspcare-2020-002467. doi: 10.1136/bmjspcare-2020-002467. Online ahead of print.

Reference Type DERIVED
PMID: 33115831 (View on PubMed)

Other Identifiers

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R137-A8861

Identifier Type: -

Identifier Source: org_study_id

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