Clinical trial NCT03466580: Improvement of Support to Caregivers of Patients in Specialized Palliative Care at Home
Official title: Testing a Caregiver-led Intervention to Improve Support to Caregivers of Patients in Specialized Palliative Care at Home: a Stepped Wedge (Cluster) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: Caregivers
Support needs
Intervention
Randomised controlled trial
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: The A.P. Moeller Foundation
name: The Palliative Unit, Amager-Hvidovre Hospital
name: Rigshospitalet, Denmark
name: Odense University Hospital
name: Arresoedal Hospice
name: Diakonissestiftelsens Hospice
name: Hospice Soendergaard
name: Nordsjaellands Hospital
name: The Palliative Team NORTH, University Hospital Sjaelland
name: Soenderjylland Hospital
First posted: 2018-03-15
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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)

Primary outcomes:
measure: Caregiver strain
timeFrame: Change from baseline (enrollment) to day 14
Secondary outcomes:
measure: Caregiver strain
timeFrame: Change from baseline (enrollment) to day 28
measure: Positive caregiving appraisals
timeFrame: Change from baseline (enrollment) to day 14
measure: Positive caregiving appraisals
timeFrame: Change from baseline (enrollment) to day 28
measure: Caregiver distress
timeFrame: Change from baseline (enrollment) to day 14
measure: Caregiver distress
timeFrame: Change from baseline (enrollment) to day 28
measure: Satisfaction with attention from health care professionals
timeFrame: Change from baseline (enrollment) to day 14
measure: Satisfaction with attention from health care professionals
timeFrame: Change from baseline (enrollment) to day 28
measure: Satisfaction with communication with health care professionals
timeFrame: Change from baseline (enrollment) to day 14
measure: Satisfaction with communication with health care professionals
timeFrame: Change from baseline (enrollment) to day 28
measure: Satisfaction with information from health care professionals
timeFrame: Change from baseline (enrollment) to day 14
measure: Satisfaction with information from health care professionals
timeFrame: Change from baseline (enrollment) to day 28
measure: Caregiving workload
timeFrame: Change from baseline (enrollment) to day 14
measure: Caregiving workload
timeFrame: Change from baseline (enrollment) to day 28
measure: Caregiver involvement
timeFrame: Change from baseline (enrollment) to day 14
measure: Caregiver involvement
timeFrame: Change from baseline (enrollment) to day 28
measure: Help from health care professionals
timeFrame: Change from baseline (enrollment) to day 14
measure: Help from health care professionals
timeFrame: Change from baseline (enrollment) to day 28
measure: Quality of life
timeFrame: Change from baseline (enrollment) to day 14
measure: Quality of life
timeFrame: Change from baseline (enrollment) to day 28
measure: Emotional functioning
timeFrame: Change from baseline (enrollment) to day 14
measure: Emotional functioning
timeFrame: Change from baseline (enrollment) to day 28
measure: Fatigue
timeFrame: Change from baseline (enrollment) to day 14
measure: Fatigue
timeFrame: Change from baseline (enrollment) to day 28
measure: Positive emotional functioning
timeFrame: Change from baseline (enrollment) to day 14
measure: Positive emotional functioning
timeFrame: Change from baseline (enrollment) to day 28
measure: Caregiver grief
timeFrame: Measured six months after the patient's death
measure: Acute hospitalizations
timeFrame: From enrollment to day 14
measure: Acute hospitalizations
timeFrame: From enrollment to day 28
measure: Hospice referrals (for in-patient care)
timeFrame: From enrollment to day 14
measure: Hospice referrals (for in-patient care)
timeFrame: From enrollment to day 28
measure: Survival time
timeFrame: From enrollment to up to six months after the project recruitment period has closed
measure: Place of death
timeFrame: From enrollment to up to six months after the project recruitment period has closed
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Department of Palliative Medicine, Bispebjerg Hospital
city: Copenhagen O
country: Denmark
facility: The Palliative unit, Rigshospitalet
city: Frederiksberg
country: Denmark
facility: Diakonissestiftelsens Hospice
city: Frederikssund
country: Denmark
facility: The Palliative Unit, Nordsjaellands Hospital
city: Frederiksvaerk
country: Denmark
facility: Arresoedal Hospice
city: Hvidovre
country: Denmark
facility: The Palliative Unit, Amager-Hvidovre Hospital
city: Maaloev
country: Denmark
facility: Hospice Soendergaard
city: Odense C
country: Denmark
facility: Palliative Team Fyn, OUH
city: Roskilde
country: Denmark
facility: The Palliative Team NORTH, University Hospital Sjaelland
city: Soenderborg
country: Denmark
facility: Palliative Team, Hospital Soenderjylland
Study officials:
affiliation: Bispebjerg Hospital
name: Mogens Groenvold, DMSc PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.