GRACE - Graduated Response for Advanced COPD With Enhanced Support
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- ICECAP-SCM
研究概览
简要总结
The aim of this study is to explore the feasibility and potential for a positive impact of a graduated response for advanced COPD with Enhanced Support. The study is a randomized controlled trial of:
- systematic needs assessment
- advance care planning
- crossectoral virtual conferences. Researchers will compare quality of life and healthcare use of the intervention group with a control group that will be assessed for intervention need at the last follow-up.
详细描述
The current study is a non-blinded randomized controlled pilot trial. The control group will be offered treatment as usual whereas the intervention group will be allocated to the GRACE model of care. In total, 100 patients and their caregivers will be included. The patients are all community dwelling and attached to the Outpatient Respiratory Medicine Clinic at Hvidovre Hospital. The patients will be randomized by block randomization to intervention and control group with a ratio of 1:1. Furthermore, the patients will be stratified according to which municipality they belong to, to ensure we gather feasibility data from two municipalities. The control group will be offered to be assessed for their eligibility for palliative care through the existing visitation conference at the end of the trial period. Endpoints include: Patient-reported (quality of life, anxiety and depression, self-efficacy), caregiver-reported ( caregiver burden, anxiety and depression, well-being) and patient healthcare use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exacerbation within the last year
- •Living in Høje Taastrup or Copenhagen
- •Cognitively relevant
- •ICECAP-SCM at least two scores of:
排除标准
- •Psychosis
- •Substance abuse
- •Hearing or speech impairment
- •Receiving specialized palliative care or other similar interventions
- •Immediately dying
结局指标
主要结局
ICECAP-SCM
时间窗: 6 months
次要结局
- ICECAP-SCM(12 months)
- HADS(12 months)
- GSE(12 months)
- Hospital admissions(12 months)
- Healthcare use, municipality(12 months)
- Healthcare use, hospital(12 months)
- Healthcare use, general practice(12 months)
- Survival(12 months)
- SF12(12 months)
研究者
Kirstine Skov Benthien
Senior Researcher, associate professor
Copenhagen University Hospital, Hvidovre