Evaluation of a Digital Support and Communication Platform for COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of hospital days during intervention and up 12 months after inclusion
研究概览
简要总结
To evaluate whether a digital support and communication platform for COPD patients after 6 months provides:
- Decreased breathlessness on the basis of modified medical research council dyspnea scale [mMRC]
- Improved health status and symptom relief based on COPD assessment scale [CAT]
- Improved quality of life based on EQ-5D
- Reduction in the number of incidents, hospital nights, the number of hospitalizations, outpatient contacts or the number of deaths related to COPD
- A change in the classification of COPD severity based on GOLD A-D
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is included in the study in connection with visits to COPD.
- •Diagnosed COPD J44 (newly discovered or existing)
- •Have completed the consent form
- •Is judged to be able to handle the intervention himself or with the help of staff or relatives
排除标准
- •Patient who declines to participate in the trial.
- •Impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner.
- •Life expectancy <8 months
- •In other ways, treating physicians are deemed to be inappropriate to participate in the study, e.g. due to participation in another study.
研究组 & 干预措施
Standard COPD care and a digital COPD support system
Device: LifePod The intervention group is testing LifePod on a digital communication platform between patient and healthcare provide
干预措施: LifePod (Device)
Control group Standard COPD Care
干预措施: LifePod (Device)
结局指标
主要结局
Number of hospital days during intervention and up 12 months after inclusion
时间窗: 12 months
Change in health status and symptom relief based on COPD assessment scale [CAT]
时间窗: 6 months
Health status and symptom is evaluated with COPD assessment scale (CAT) where the scale is from 0-40 and where high score represent worse health status and symptoms
Change in quality of life
时间窗: 6 months
Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life
A change in the classification of COPD severity based on GOLD A-D
时间窗: 6 months
A change in the classification of COPD severity based on GOLD 1-4 (A-D) where high figure represent worse severity
Change in patient reported symptoms
时间窗: 6 months
Improved patient-reported symptoms as measured by questionnaire EuroQol three-dimensional questionnaire (EQ-5D-3L ) where high score represent worse symptoms. The minimum score is 7 points and the maximum score is 23 points.
Severity of dyspnea on the basis of modified medical research council dyspnea scale [mMRC]
时间窗: 6 months
Dyspnea is measured with mMRC from 0-4 where high figure represent dyspnea in minimal exertion
Number of participants with new hospitalization up 12 months after inclusion
时间窗: 12 months
Number of health care visits during intervention and up to 12 months after inclusion
时间窗: 12 months
Number of participants with COPD related events and deaths during intervention and up to 12 months after inclusion
时间窗: 12 months
次要结局
未报告次要终点
研究者
Sofia Gerward
Principal Investigator, MD, PhD
Lund University