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临床试验/NCT01984840
NCT01984840已完成不适用

Effectiveness and Cost-effectiveness of Telemedicine for Chronic Obstructive Pulmonary Disease: The Danish "TeleCare North" Pragmatic Cluster-randomized Trial.

Aalborg University2 个研究点 分布在 1 个国家目标入组 1,225 人开始时间: 2013年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,225
试验地点
2
主要终点
Incremental cost-effectiveness ratio (ICER)

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 COPD 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 COPD across patients and municipality districts.

It is hypothesized that telehealth care will increase patients quality adjusted life years at both the cluster and individual level 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

入选标准

  • diagnosed COPD by spirometry
  • in treatment corresponding to GOLD-guidelines
  • motivated for treatment of COPD
  • COPD is the primary disease
  • fixed residence and be affiliated to a general practitioner in North Denmark Region
  • At least one of the following criteria should also be met: MRCm (modified) ≥ 2 or MRC ≥3, CAT ≥ 10, have had at least 2 exacerbations within the last 12 months

排除标准

  • no phone line or GSM coverage
  • unable to understand Danish sufficiently to complete study questionnaires
  • have a cognitive impairment

结局指标

主要结局

Incremental cost-effectiveness ratio (ICER)

时间窗: 12 month follow-up

Health related quality of life

时间窗: 12 month follow-up

SF-36

次要结局

未报告次要终点

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ole K Hejlesen, PhD

Professor

Aalborg University

研究点 (2)

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