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

NCT03466580 | Completed

• 1 other identifier: R137-A8861
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Palliative Care

Keywords

Caregivers; Support needs; Intervention; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Caregiver strain

  Caregiver strain is measured by the subscale 'Caregiver Strain' in the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). Subscale score range: 1-5. A higher score represents a worse outcome, i.e. more caregiver strain.

  Change from baseline (enrollment) to day 14

Secondary Outcomes (32)

• Caregiver strain

  Change from baseline (enrollment) to day 28

• Positive caregiving appraisals

  Change from baseline (enrollment) to day 14

• Positive caregiving appraisals

  Change from baseline (enrollment) to day 28

• Caregiver distress

  Change from baseline (enrollment) to day 14

• Caregiver distress

  Change from baseline (enrollment) to day 28

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: The Carer Support Needs Assessment Tool (CSNAT) intervention

Control

NO INTERVENTION

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

Interventions

The Carer Support Needs Assessment Tool (CSNAT) intervention 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Danish Cancer Society: collaborator
• The A.P. Moeller Foundation: collaborator
• The Palliative Unit, Amager-Hvidovre Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Odense University Hospital: collaborator
• Arresoedal Hospice: collaborator
• Diakonissestiftelsens Hospice: collaborator
• Hospice Soendergaard: collaborator
• Nordsjaellands Hospital: collaborator
• The Palliative Team NORTH, University Hospital Sjaelland: collaborator
• Soenderjylland Hospital: collaborator

Study Sites (10)

Department of Palliative Medicine, Bispebjerg Hospital

Copenhagen NV, DK-2400, Denmark

Location

The Palliative unit, Rigshospitalet

Copenhagen O, DK-2100, Denmark

Location

Diakonissestiftelsens Hospice

Frederiksberg, DK-2000, Denmark

Location

The Palliative Unit, Nordsjaellands Hospital

Frederikssund, DK-3600, Denmark

Location

Arresoedal Hospice

Frederiksværk, DK-3300, Denmark

Location

The Palliative Unit, Amager-Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Location

Hospice Soendergaard

Maaloev, DK-2760, Denmark

Location

Palliative Team Fyn, OUH

Odense C, DK-5000, Denmark

Location

The Palliative Team NORTH, University Hospital Sjaelland

Roskilde, DK-4000, Denmark

Location

Palliative Team, Hospital Soenderjylland

Sønderborg, DK-6400, Denmark

Location

Related Publications (2)

• 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.

  PMID: 34296334 DERIVED

• 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.

  PMID: 33115831 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Mogens Groenvold, DMSc PhD MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DMSc, PhD, MD

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 15, 2018
• Study Start: March 15, 2018
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (10)