HELPing Older People With Very Severe Chronic Obstructive Pulmonary Disease (COPD) Towards the End of Their Lives: Developing, Piloting and Refining a Practical Intervention (HELP-COPD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- FACIT
研究概览
简要总结
The purpose of this study is to develop, refine and pilot a novel complex (HELP-COPD) assessment, undertaken during or immediately after a hospital admission, which addresses the holistic care needs of people with severe chronic obstructive pulmonary disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered with Lothian General Practice
- •Admitted with an exacerbation of COPD as their primary diagnosis at Royal Infirmary of Edinburgh
排除标准
- •People with lung cancer
- •People unable to give informed consent and complete questionnaire booklets in English
研究组 & 干预措施
Intervention group
干预措施: HELP-COPD action plan (Other)
Control group
结局指标
主要结局
FACIT
时间窗: 3 and 6 months
The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system has a core of 27 validated questions in four domains: Physical, Social/Family, Emotional, and Functional well-being. Scores range from 0 (worst quality of life) to 108, and are responsive to change with a minimum clinically important difference for improvement of 5.5. A sub-scale of 10 questions for use in lung cancer is considered to be appropriate in other respiratory conditions.
次要结局
- MRC Dyspnoea score(3 and 6 months)
- Dyspnoea 12(3 and 6 months)
- The St George Respiratory Questionnaire (SGRQ)(3 and 6 months)
- COPD Assessment Test (CAT)(3 and 6 months)
- The Hospital Anxiety and Depression Scale (HADS)(3 and 6 months)
- FACIT Spiritual Well-Being sub-scale (FACIT-Sp)(3 and 6 months)
- Palliative care Outcome Scale (POS)(3 and 6 months)
- EQ-5D(3 and 6 months)