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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
466
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.
Department of Palliative Medicine, Bispebjerg Hospital
Copenhagen NV, Denmark
The Palliative unit, Rigshospitalet
Copenhagen O, Denmark
Diakonissestiftelsens Hospice
Frederiksberg, Denmark
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.
Time frame: Change from baseline (enrollment) to day 14
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.
Time frame: Change from baseline (enrollment) to day 28
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.
Time frame: Change from baseline (enrollment) to day 14
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.
Time frame: Change from baseline (enrollment) to day 28
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.
Time frame: Change from baseline (enrollment) to day 14
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The Palliative Unit, Nordsjaellands Hospital
Frederikssund, Denmark
Arresoedal Hospice
Frederiksværk, 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
Sønderborg, Denmark
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
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Change from baseline (enrollment) to day 14
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
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Change from baseline (enrollment) to day 14
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
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Change from baseline (enrollment) to day 14
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
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Change from baseline (enrollment) to day 14
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
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Change from baseline (enrollment) to day 14
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
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Change from baseline (enrollment) to day 14
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
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Change from baseline (enrollment) to day 14
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
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Change from baseline (enrollment) to day 14
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
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Change from baseline (enrollment) to day 14
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
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Change from baseline (enrollment) to day 14
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
Time frame: Change from baseline (enrollment) to day 28
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
Time frame: Measured six months after the patient's death
Acute hospitalizations
Number of acute patient hospitalizations
Time frame: From enrollment to day 14
Acute hospitalizations
Number of acute patient hospitalizations
Time frame: From enrollment to day 28
Hospice referrals (for in-patient care)
Number of patients referred to hospice in-patient care
Time frame: From enrollment to day 14
Hospice referrals (for in-patient care)
Number of patients referred to hospice in-patient care
Time frame: From enrollment to day 28
Survival time
Number of days the patient lives
Time frame: From enrollment to up to six months after the project recruitment period has closed
Place of death
The place in which the patient dies
Time frame: From enrollment to up to six months after the project recruitment period has closed