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Completed

NCT Number: NCT03466580

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

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

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Key information

Conditions

Palliative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen NV, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Caregiver strain

    Time frame: Change from baseline (enrollment) to day 14

    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.

Secondary outcomes

  1. Caregiver strain

    Time frame: Change from baseline (enrollment) to day 28

    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.

  2. Positive caregiving appraisals

    Time frame: Change from baseline (enrollment) to day 14

    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.

  3. Positive caregiving appraisals

    Time frame: Change from baseline (enrollment) to day 28

    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.

  4. Caregiver distress

    Time frame: Change from baseline (enrollment) to day 14

    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.

  5. Caregiver distress

    Time frame: Change from baseline (enrollment) to day 28

    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

  6. Satisfaction with attention from health care professionals

    Time frame: Change from baseline (enrollment) to day 14

    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

  7. Satisfaction with attention from health care professionals

    Time frame: Change from baseline (enrollment) to day 28

    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

  8. Satisfaction with communication with health care professionals

    Time frame: Change from baseline (enrollment) to day 14

    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

  9. Satisfaction with communication with health care professionals

    Time frame: Change from baseline (enrollment) to day 28

    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

  10. Satisfaction with information from health care professionals

    Time frame: Change from baseline (enrollment) to day 14

    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

  11. Satisfaction with information from health care professionals

    Time frame: Change from baseline (enrollment) to day 28

    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

  12. Caregiving workload

    Time frame: Change from baseline (enrollment) to day 14

    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

  13. Caregiving workload

    Time frame: Change from baseline (enrollment) to day 28

    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

  14. Caregiver involvement

    Time frame: Change from baseline (enrollment) to day 14

    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

  15. Caregiver involvement

    Time frame: Change from baseline (enrollment) to day 28

    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

  16. Help from health care professionals

    Time frame: Change from baseline (enrollment) to day 14

    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

  17. Help from health care professionals

    Time frame: Change from baseline (enrollment) to day 28

    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

  18. Quality of life

    Time frame: Change from baseline (enrollment) to day 14

    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

  19. Quality of life

    Time frame: Change from baseline (enrollment) to day 28

    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

  20. Emotional functioning

    Time frame: Change from baseline (enrollment) to day 14

    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

  21. Emotional functioning

    Time frame: Change from baseline (enrollment) to day 28

    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

  22. Fatigue

    Time frame: Change from baseline (enrollment) to day 14

    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

  23. Fatigue

    Time frame: Change from baseline (enrollment) to day 28

    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

  24. Positive emotional functioning

    Time frame: Change from baseline (enrollment) to day 14

    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

  25. Positive emotional functioning

    Time frame: Change from baseline (enrollment) to day 28

    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

  26. Caregiver grief

    Time frame: Measured six months after the patient's death

    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

  27. Acute hospitalizations

    Time frame: From enrollment to day 14

    Number of acute patient hospitalizations

  28. Acute hospitalizations

    Time frame: From enrollment to day 28

    Number of acute patient hospitalizations

  29. Hospice referrals (for in-patient care)

    Time frame: From enrollment to day 14

    Number of patients referred to hospice in-patient care

  30. Hospice referrals (for in-patient care)

    Time frame: From enrollment to day 28

    Number of patients referred to hospice in-patient care

  31. Survival time

    Time frame: From enrollment to up to six months after the project recruitment period has closed

    Number of days the patient lives

  32. Place of death

    Time frame: From enrollment to up to six months after the project recruitment period has closed

    The place in which the patient dies

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • 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

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2018
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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