Effectiveness and Cost-effectiveness of Telemedicine for Heart Failure: The Danish "TeleCare North" Pragmatic Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Mental health related quality of life (SF-36 questionnaire mental scores)
研究概览
简要总结
There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from Heart Failure that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with Heart Failure across patients and municipality districts.
It is hypothesized that telehealth care will increase patients quality adjusted life years compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All heart failure patients that may benefit from telehealthcare.
- •Participants are qualified for inclusion if they have been diagnosed with HF according to national guidelines and are NYHA classified 2,3, and
- •Patients must have a permanent residence and be motivated for using telehealthcare. *Patients must have a landline or mobile phone and be able to speak Danish or they must live with a relative speaking Danish. Such that the relative must be able to help the patient in translating the information in the use of telehealthcare.
排除标准
- •Patients without landline phone / mobile phone or GSM (Global System for Mobile Communications) coverage.
- •Patients not able to understand Danish adequately to complete the questionnaires in the study or patients having a cognitive impairment.
- •Comorbidity is not an exclusion criterion.
结局指标
主要结局
Mental health related quality of life (SF-36 questionnaire mental scores)
时间窗: 12 month follow-up
Changes in mental health-related quality of life (SF-36 questionnaire mental score) at baseline to follow-up.
Incremental cost-effectiveness ratio (ICER)
时间窗: 12 month follow-up
The main outcome for cost is incremental cost-effectiveness ratio (ICER). ICER is measured as the total cost per quality adjusted life years (QALY) increased from baseline to follow-up.
次要结局
- Changes in daily functioning (KCCQ questionnaire score)(12 month follow-up)
- Physical health related quality of life (SF-36 questionnaire Physical scores)(12 month follow-up)
研究者
Ole K. Hejlesen
Professor
Aalborg University
