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

Palliative Care Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466580
• Other study ID #: R137-A8861
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2021
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 466
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Palliative Care

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Denmark	Department of Palliative Medicine, Bispebjerg Hospital	Copenhagen NV
Denmark	The Palliative unit, Rigshospitalet	Copenhagen O
Denmark	Diakonissestiftelsens Hospice	Frederiksberg
Denmark	The Palliative Unit, Nordsjaellands Hospital	Frederikssund
Denmark	Arresoedal Hospice	Frederiksvaerk
Denmark	The Palliative Unit, Amager-Hvidovre Hospital	Hvidovre
Denmark	Hospice Soendergaard	Maaloev
Denmark	Palliative Team Fyn, OUH	Odense C
Denmark	The Palliative Team NORTH, University Hospital Sjaelland	Roskilde
Denmark	Palliative Team, Hospital Soenderjylland	Soenderborg

Sponsors (12)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 28
Secondary	Positive caregiving appraisals	Positive caregiving appraisals is measured by the subscale 'Positive caregiving appraisals' in the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). Subscale score range: 1-5. A higher score represents a better outcome, i.e. more positive caregiving appraisals.	Change from baseline (enrollment) to day 14
Secondary	Positive caregiving appraisals	Positive caregiving appraisals is measured by the subscale 'Positive caregiving appraisals' in the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). Subscale score range: 1-5. A higher score represents a better outcome, i.e. more positive caregiving appraisals.	Change from baseline (enrollment) to day 28
Secondary	Caregiver distress	Caregiver distress is measured by the subscale 'Caregiver distress' 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 distress.	Change from baseline (enrollment) to day 14
Secondary	Caregiver distress	Caregiver distress is measured by the subscale 'Caregiver distress' 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 distress	Change from baseline (enrollment) to day 28
Secondary	Satisfaction with attention from health care professionals	Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals	Change from baseline (enrollment) to day 14
Secondary	Satisfaction with attention from health care professionals	Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals	Change from baseline (enrollment) to day 28
Secondary	Satisfaction with communication with health care professionals	Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals	Change from baseline (enrollment) to day 14
Secondary	Satisfaction with communication with health care professionals	Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals	Change from baseline (enrollment) to day 28
Secondary	Satisfaction with information from health care professionals	Measured with selected items from the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals	Change from baseline (enrollment) to day 14
Secondary	Satisfaction with information from health care professionals	Measured with selected items from the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals	Change from baseline (enrollment) to day 28
Secondary	Caregiving workload	Measured with selected items from the subscale 'Caregiving workload' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more caregiving workload	Change from baseline (enrollment) to day 14
Secondary	Caregiving workload	Measured with selected items from the subscale 'Caregiving workload' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more caregiving workload	Change from baseline (enrollment) to day 28
Secondary	Caregiver involvement	Measured with item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement	Change from baseline (enrollment) to day 14
Secondary	Caregiver involvement	Measured with item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement	Change from baseline (enrollment) to day 28
Secondary	Help from health care professionals	Measured with two newly developed items which ask whether the health care professionals have talked with the caregiver about what burdens them, and whether the health care professionals have helped with these burdens. Item score range: 0-100. A higher score represents a worse outcome, i.e. less help from health care professionals	Change from baseline (enrollment) to day 14
Secondary	Help from health care professionals	Measured with two newly developed items which ask whether the health care professionals have talked with the caregiver about what burdens them, and whether the health care professionals have helped with these burdens. Item score range: 0-100. A higher score represents a worse outcome, i.e. less help from health care professionals	Change from baseline (enrollment) to day 28
Secondary	Quality of life	Measured by the two items assessing overall health and quality of life in the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Item score range: 0-100. A higher score represents a better outcome, i.e. better quality of life	Change from baseline (enrollment) to day 14
Secondary	Quality of life	Measured by the two items assessing overall health and quality of life in the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Item score range: 0-100. A higher score represents a better outcome, i.e. better quality of life	Change from baseline (enrollment) to day 28
Secondary	Emotional functioning	Measured by the four emotional functioning items in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) supplemented with three selected items from the EORTC Computerized Adaptive Test (CAT) emotional functioning item bank. Item/subscale score range: 0-100. A higher score represents a better outcome, i.e. better emotional functioning	Change from baseline (enrollment) to day 14
Secondary	Emotional functioning	Measured by the four emotional functioning items in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) supplemented with three selected items from the EORTC Computerized Adaptive Test (CAT) emotional functioning item bank. Item/subscale score range: 0-100. A higher score represents a better outcome, i.e. better emotional functioning	Change from baseline (enrollment) to day 28
Secondary	Fatigue	Measured by the three fatigue items in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) supplemented with three selected items from the EORTC Computerized Adaptive Test (CAT) fatigue item bank. Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more fatigue	Change from baseline (enrollment) to day 14
Secondary	Fatigue	Measured by the three fatigue items in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) supplemented with three selected items from the EORTC Computerized Adaptive Test (CAT) fatigue item bank. Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more fatigue	Change from baseline (enrollment) to day 28
Secondary	Positive emotional functioning	Measured by five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Item score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning	Change from baseline (enrollment) to day 14
Secondary	Positive emotional functioning	Measured by five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Item score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning	Change from baseline (enrollment) to day 28
Secondary	Caregiver grief	Measured by the Prolonged Grief Scale-13 (PG-13). Symptom subscale score range: 9-45. A higher score represents a worse outcome, i.e. higher level of prolonged grief symptoms	Measured six months after the patient's death
Secondary	Acute hospitalizations	Number of acute patient hospitalizations	From enrollment to day 14
Secondary	Acute hospitalizations	Number of acute patient hospitalizations	From enrollment to day 28
Secondary	Hospice referrals (for in-patient care)	Number of patients referred to hospice in-patient care	From enrollment to day 14
Secondary	Hospice referrals (for in-patient care)	Number of patients referred to hospice in-patient care	From enrollment to day 28
Secondary	Survival time	Number of days the patient lives	From enrollment to up to six months after the project recruitment period has closed
Secondary	Place of death	The place in which the patient dies	From enrollment to up to six months after the project recruitment period has closed