NCT03466580已完成不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 466
- 试验地点
- 10
- 主要终点
- Caregiver strain
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Intervention
Experimental
('Standard' specialized palliative care +) The Carer Support Needs Assessment Tool (CSNAT) intervention.
干预措施: The Carer Support Needs Assessment Tool (CSNAT) intervention (Behavioral)
Control
No Intervention
('Standard' specialized palliative care). No intervention offered.
结局指标
主要结局
Caregiver strain
时间窗: 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.
次要结局
- Caregiver grief(Measured six months after the patient's death)
- Satisfaction with communication with health care professionals(Change from baseline (enrollment) to day 28)
- Caregiver distress(Change from baseline (enrollment) to day 28)
- Caregiving workload(Change from baseline (enrollment) to day 28)
- Satisfaction with attention from health care professionals(Change from baseline (enrollment) to day 28)
- Survival time(From enrollment to up to six months after the project recruitment period has closed)
- Caregiver strain(Change from baseline (enrollment) to day 28)
- Positive caregiving appraisals(Change from baseline (enrollment) to day 28)
- Fatigue(Change from baseline (enrollment) to day 28)
- Positive emotional functioning(Change from baseline (enrollment) to day 28)
- Acute hospitalizations(From enrollment to day 28)
- Hospice referrals (for in-patient care)(From enrollment to day 28)
- Satisfaction with information from health care professionals(Change from baseline (enrollment) to day 28)
- Caregiver involvement(Change from baseline (enrollment) to day 28)
- Help from health care professionals(Change from baseline (enrollment) to day 28)
- Quality of life(Change from baseline (enrollment) to day 28)
- Emotional functioning(Change from baseline (enrollment) to day 28)
- Place of death(From enrollment to up to six months after the project recruitment period has closed)
- Positive caregiving appraisals(Change from baseline (enrollment) to day 14)
- Caregiver distress(Change from baseline (enrollment) to day 14)
- Satisfaction with attention from health care professionals(Change from baseline (enrollment) to day 14)
- Satisfaction with communication with health care professionals(Change from baseline (enrollment) to day 14)
- Satisfaction with information from health care professionals(Change from baseline (enrollment) to day 14)
- Caregiving workload(Change from baseline (enrollment) to day 14)
- Caregiver involvement(Change from baseline (enrollment) to day 14)
- Help from health care professionals(Change from baseline (enrollment) to day 14)
- Quality of life(Change from baseline (enrollment) to day 14)
- Emotional functioning(Change from baseline (enrollment) to day 14)
- Fatigue(Change from baseline (enrollment) to day 14)
- Positive emotional functioning(Change from baseline (enrollment) to day 14)
- Acute hospitalizations(From enrollment to day 14)
- Hospice referrals (for in-patient care)(From enrollment to day 14)
研究者
Mogens Groenvold
Professor, DMSc, PhD, MD
Bispebjerg Hospital
研究点 (10)
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