A Pragmatic Randomized Control Trial Comparing Telehealth With Standard Clinical Care in the Follow-up of Patients With Chronic Conditions Within the Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 732
- 试验地点
- 9
- 主要终点
- Mean change in overall satisfaction with treatment and follow-up from baseline at 18 months
研究概览
简要总结
The Norwegian health authorities has initiated a three-year trial of telehealth solutions as part of the treatment of patients with chronic illness in the period 2018-2021. Within the trial, telehealth indicates that patients are followed-up outside health-care facilities using information and communication technologies (ICTs). Patients who are followed up using telehealth solutions can answer questions about their own health and/or perform measurements related to their health (e.g. blood pressure, blood glucose, oxygen measurement, weight) via a tablet according to a personalized schedule. The measurement values are transferred from the measuring devices to a tablet so that the users can easily see them and track their results over time. The results are also transmitted digitally to a follow-up service, a healthcare center with nurses, who contacts the patient when needed. The follow-up service provides medical support and guidance based on the patient's needs and planned follow-up, and will, in consultation with the user, evaluate whether the user should contact the general practitioner (GP) or emergency room.
The study population of the trial includes users with comprehensive medical needs, with medium to high risk of worsening of their condition, hospitalization or increased need for health and care services.
The evaluation includes three main parts: 1) An effect evaluation which is designed as a randomized control trial, 2) a cost-benefit analysis, and 3) a process evaluation which aims to provide recommendations for how to organize and implement telemedicine in clinical practice. The primary outcomes include physical and mental health state, patient experience and use of health services.
The effect evaluation is designed as a pragmatic open label multi-center randomized control trial, with two parallel arms with 300 patients in each arm. Patients are recruited between February 2019 and June 2020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a considerable disease burden and comprehensive medical needs
- •The patient has a chronic disease
- •The patient has medium to high risk of worsening of their condition, hospitalization or increased need for health and care services
- •The patient has a high consumption of healthcare services
- •The patient has a reduced level of function
- •The patient is motivated to use telehealth solutions
- •The patient is likely to benefit from the use of telehealth solutions
排除标准
- •The patient is not competent to consent
- •The patient is unable to handle the tablet and the measuring equipment to be used
- •The patient has a substance abuse
结局指标
主要结局
Mean change in overall satisfaction with treatment and follow-up from baseline at 18 months
时间窗: Measured as change from baseline to 18 months after inclusion
Patients are asked to assess their overall satisfaction with their health care services: "To what extent are you satisfied with the follow-up of your health?". Answers on a four point scale ranging from "Not satisfied at all" to "Very satisfied"
Change in yearly health and care cost per person from baseline at 12 months
时间窗: Yearly health and care cost per person is calculated at baseline and at 12 months after inclusion.
The total cost of health and care services per patient is calculated by combining information on the use of health and care services with information about private and public costs of health and care services. Yearly health and care cost per person at baseline is defined as the yearly cost 365 days before inclusion. Similarly, the health and care cost at 12 months in defined as the total cost in the first year after inclusion. The change in mean is the primary outcome measure. Other changes, such as distributional changes, may be of interest.
Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 6 months
时间窗: Measured as change from baseline to 6 months after inclusion
Patient's assessment of her health-related quality of life using Visual Analogue Scale (VAS). The scale goes from 0 to 100 where higher scores mean a better outcome.
Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 12 months
时间窗: Measured as change from baseline to 12 months after inclusion
Patient's assessment of her health-related quality of life using the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire. The scale goes from 0 to 1 where higher scores mean a better outcome.
Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 18 months
时间窗: Measured as change from baseline to 18 months after inclusion
Patient's assessment of her health-related quality of life using the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire. The scale goes from 0 to 1 where higher scores mean a better outcome.
Mean change in overall satisfaction with treatment and follow-up from baseline at 6 months
时间窗: Measured as change from baseline to 6 months after inclusion
Patients are asked to assess their overall satisfaction with their health care services: "To what extent are you satisfied with the follow-up of your health?". Answers on a four point scale ranging from "Not satisfied at all" to "Very satisfied"
Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 6 months
时间窗: Measured as change from baseline to 6 months after inclusion
Patient's assessment of her health-related quality of life using the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire. The scale goes from 0 to 1 where higher scores mean a better outcome.
Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 12 months
时间窗: Measured as change from baseline to 12 months after inclusion
Patient's assessment of her health-related quality of life using Visual Analogue Scale (VAS). The scale goes from 0 to 100 where higher scores mean a better outcome.
Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 18 months
时间窗: Measured as change from baseline to 18 months after inclusion
Patient's assessment of her health-related quality of life using Visual Analogue Scale (VAS). The scale goes from 0 to 100 where higher scores mean a better outcome.
Mean change in overall satisfaction with treatment and follow-up from baseline at 12 months
时间窗: Measured as change from baseline to 12 months after inclusion
Patients are asked to assess their overall satisfaction with their health care services: "To what extent are you satisfied with the follow-up of your health?". Answers on a four point scale ranging from "Not satisfied at all" to "Very satisfied"
次要结局
- Mean change in patients' satisfaction with involvement of the GP from baseline at 6 months(Measured as change from baseline to 6 months after inclusion)
- Mean change in patients' satisfaction with involvement of the GP from baseline at 12 months(Measured as change from baseline to 12 months after inclusion)
- Mean change in sleep quality from baseline at 12 months(Measured as change from baseline to 12 months after inclusion)
- Mean change in patients' sense of control over their health situation from baseline at 6 months(Measured as change from baseline to 6 months after inclusion)
- Mean change in sleep quality from baseline at 6 months(Measured as change from baseline to 6 months after inclusion)
- Mean change in sleep quality from baseline at 18 months(Measured as change from baseline to 18 months after inclusion)
- Mean change in patients' sense of control over their health situation from baseline at 12 months(Measured as change from baseline to 12 months after inclusion)
- Mean change in patients' sense of control over their health situation from baseline at 18 months(Measured as change from baseline to 18 months after inclusion)
- Mean change in the patients' number of appointments with the GP services from baseline at 12 months(Yearly use of the GP services is calculated at baseline and at 12 months after inclusion.)
- Mean change in the patients' number of home nursing visits from baseline at 6 months(Use of home nursing visits is measured one month prior to inclusion and 6 months after inclusion.)
- Mean change in the patients' duration of home nursing visits from baseline at 12 months(Total duration of home nursing visits is measured one month prior to inclusion and 12 months after inclusion.)
- Mean change in the patients' number of municipal emergency day care unit visits from baseline at 6 months(Use of municipal emergency day care unit visits is measured one month prior to inclusion and 6 months after inclusion.)
- Mean change in the patients' number of municipal emergency day care unit visits from baseline at 18 months(Use of municipal emergency day care unit visits is measured one month prior to inclusion and 18 months after inclusion.)
- Mean change in patients' satisfaction with involvement of the GP from baseline at 18 months(Measured as change from baseline to 18 months after inclusion)
- Mean change in patients' sense of user involvement from baseline at 6 months(Measured as change from baseline to 6 months after inclusion)
- Mean change in patients' sense of user involvement from baseline at 12 months(Measured as change from baseline to 12 months after inclusion)
- Mean change in the patients' number of home nursing visits from baseline at 12 months(Use of home nursing visits is measured one month prior to inclusion and 12 months after inclusion.)
- Mean change in the patients' duration of municipal emergency day care unit visits from baseline at 12 months(Total duration of municipal emergency day care unit visits is measured one month prior to inclusion and 12 months after inclusion.)
- Mean change in patients' sense of user involvement from baseline at 18 months(Measured as change from baseline to 18 months after inclusion)
- Mean change in the patients' number of home nursing visits from baseline at 18 months(Use of home nursing visits is measured one month prior to inclusion and 18 months after inclusion.)
- Mean change in the patients' duration of home nursing visits from baseline at 6 months(Total duration of home nursing visits is measured one month prior to inclusion and 6 months after inclusion.)
- Mean change in the patients' duration of home nursing visits from baseline at 18 months(Total duration of home nursing visits is measured one month prior to inclusion and 18 months after inclusion.)
- Mean change in the patients' number of municipal emergency day care unit visits from baseline at 12 months(Use of municipal emergency day care unit visits is measured one month prior to inclusion and 12 months after inclusion.)
- Mean change in the patients' number of outpatient visits from baseline at 12 months(Yearly number of outpatient visits is calculated at baseline and at 12 months after inclusion.)
- Mean change in the patients' number of inpatient visits from baseline at 12 months(Yearly number of inpatient visits is calculated at baseline and at 12 months after inclusion.)
- Mean change in the patients' duration of inpatient visits from baseline at 12 months(Total duration of inpatient visits is calculated at baseline and at 12 months after inclusion.)
- Mean change in the patients' number of emergency room visits from baseline at 12 months(Yearly number of emergency room visits is calculated at baseline and at 12 months after inclusion.)
- Mean change in the patients' duration of municipal emergency day care unit visits from baseline at 6 months(Total duration of municipal emergency day care unit visits is measured one month prior to inclusion and 6 months after inclusion.)
- Mean change in the patients' duration of municipal emergency day care unit visits from baseline at 18 months(Total duration of municipal emergency day care unit visits is measured one month prior to inclusion and 18 months after inclusion.)
研究者
Tor Iversen
Professor of Health Economics
University of Oslo