Evaluation of a Digital Support and Communication Platform for Heart Failure:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Self-care behaviour
研究概览
简要总结
The purpose of the study is to evaluate if the digital support and communication platform for heart failure can provide patients with heart failure increased knowledge, compliance and quality of life and thus affect re-admissions and visit structure.
To evaluate whether a digital support and communication platform for heart failure patients after 6 months can provide:
- Improved self-care
- Improved quality of life and reduced number of patient-assessed symptoms
- Reduction in the number of cardiovascular events, hospital nights, the number of hospitalizations or the number of deaths and out-patient visits
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
- Double (Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed heart failure I.50 (newly discovered or existing) in NYHA Class I-IV in principle with ESC guidelines
- •Have completed the "consent form" or consent form, see §4.2 Exclusion criteria: * Patient who refuses to participate in the trial.
- •It is assessed that they can handle the intervention themselves or with the help of personal 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, by the treating physician, it is deemed inappropriate to participate in the study, e.g. due to participation in another study.
结局指标
主要结局
Self-care behaviour
时间窗: 6 month
Improvement in self-care behaviour measured by the questionnaire European Heart Failure Self-care behaviour scale (EHFScB-9) A higher EHFScB-9 score indicates a worse self-care behaviour. The minimum score is 9 points and the maximum score is 45.
Cardiovascular events and deaths
时间窗: 12 month
Number of participants with cardiovascular events and deaths during intervention and up to 12 months after inclusion
Hospitalization and hospital days
时间窗: 12 months
Number of participants with new hospitalization and number of hospital days during intervention and up 12 months after inclusion
Health care visits
时间窗: 12 months
Type and number of health care visits during intervention and up to 12 months after inclusion
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.
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
次要结局
未报告次要终点
研究者
Sofia Gerward
Principal Investigator
Lund University