Pragmatic Randomized Control Trial of Telehealth vs Standard Care in Follow-up of Patients With Chronic Conditions

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Disease, Diabetes, Vascular Diseases, Chronic Lung Disease, Cancer, Psychiatric Disorder

Intervention / Treatment
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* Device: Telemedicine: tablet and possibly tools to perform measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Follow-up using telehealth solutions<br>Participants in this arm are followed up using a telehealth solution, as specified by the National Directorate of Health at the local centre. The actual follow-up is personalized to the individual user. All users receive a tablet, which can be used to answer questions about own health and/or transmit clinical measurements. | Device: Telemedicine: tablet and possibly tools to perform measurements<br>* Users of telemedicine can answer simple questions about their health condition and/or perform measurements related to their health (e.g., blood pressure, blood sugar, oxygen saturation, weight) via a tablet or a similar device. The results are transferred from the measuring devices to the tablet so that users can easily see them and track their own results over time. The results are transmitted digitally to a follow-up service. The follow-up service contacts the patient in case of signs of deterioration or when measurements lie outside what is normal values for the individual. The follow-up service provides medical support and guidance based on the patient's needs and plan for follow-up, and will, in consultation with the patient, assess whether this should contact their GP/emergency room.<br>|
| No Intervention: Standard clinical care<br>Participants in this arm receive standard clinical care in accordance with their medinal needs. | |
| Experimental: Non-randomized follow-up using telehealth solutions<br>Participants in this arm are followed up using a telehealth solution, as specified by the National Directorate of Health at the local centre. The actual follow-up is personalized to the individual user. All users receive a tablet, which can be used to answer questions about own health and/or transmit clinical measurements. This arm is not randomized, but otherwise identical to the randomized experimental arm. | Device: Telemedicine: tablet and possibly tools to perform measurements<br>* Users of telemedicine can answer simple questions about their health condition and/or perform measurements related to their health (e.g., blood pressure, blood sugar, oxygen saturation, weight) via a tablet or a similar device. The results are transferred from the measuring devices to the tablet so that users can easily see them and track their own results over time. The results are transmitted digitally to a follow-up service. The follow-up service contacts the patient in case of signs of deterioration or when measurements lie outside what is normal values for the individual. The follow-up service provides medical support and guidance based on the patient's needs and plan for follow-up, and will, in consultation with the patient, assess whether this should contact their GP/emergency room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 6 months | 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. | Measured as change from baseline to 6 months after inclusion | 
| Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 12 months | 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. | Measured as change from baseline to 12 months after inclusion | 
| Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 18 months | 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. | Measured as change from baseline to 18 months after inclusion | 
| Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 6 months | 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. | Measured as change from baseline to 6 months after inclusion | 
| Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 12 months | 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. | Measured as change from baseline to 12 months after inclusion | 
| Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 18 months | 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. | Measured as change from baseline to 18 months after inclusion | 
| Mean change in overall satisfaction with treatment and follow-up from baseline at 6 months | 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 | Measured as change from baseline to 6 months after inclusion | 
| Mean change in overall satisfaction with treatment and follow-up from baseline at 12 months | 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 | Measured as change from baseline to 12 months after inclusion | 
| Mean change in overall satisfaction with treatment and follow-up from baseline at 18 months | 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 | Measured as change from baseline to 18 months after inclusion | 
| Change in yearly health and care cost per person from baseline at 12 months | 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. | Yearly health and care cost per person is calculated at baseline and at 12 months after inclusion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in sleep quality from baseline at 6 months | Participants are asked the following question: If you think about the last 7 days, to what degree have you experienced the following a) had problems sleeping at night b) had problems sleeping too much? Answers on a four point scale ranging from Not at all to To a very large extent. | Measured as change from baseline to 6 months after inclusion | 
| Mean change in sleep quality from baseline at 12 months | Participants are asked the following question: If you think about the last 7 days, to what degree have you experienced the following a) had problems sleeping at night b) had problems sleeping too much? Answers on a four point scale ranging from Not at all to To a very large extent. | Measured as change from baseline to 12 months after inclusion | 
| Mean change in sleep quality from baseline at 18 months | Participants are asked the following question: If you think about the last 7 days, to what degree have you experienced the following a) had problems sleeping at night b) had problems sleeping too much? Answers on a four point scale ranging from Not at all to To a very large extent. | Measured as change from baseline to 18 months after inclusion | 
| Mean change in patients' sense of control over their health situation from baseline at 6 months | Participants are asked the following question: To what extent do you feel that you have control over your health situation? Answers on a four point scale ranging from Not at all to To a very large extent. | Measured as change from baseline to 6 months after inclusion | 
| Mean change in patients' sense of control over their health situation from baseline at 12 months | Participants are asked the following question: To what extent do you feel that you have control over your health situation? Answers on a four point scale ranging from Not at all to To a very large extent. | 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 | Participants are asked the following question: To what extent do you feel that you have control over your health situation? Answers on a four point scale ranging from Not at all to To a very large extent. | Measured as change from baseline to 18 months after inclusion | 
| Mean change in patients' satisfaction with involvement of the GP from baseline at 6 months | Patients answer the question To what extent do you experience your GP is sufficiently involved in the follow-up of your health? Answers are reported on a four point scale: Not at all to To a very large extent. | 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 | Patients answer the question To what extent do you experience your GP is sufficiently involved in the follow-up of your health? Answers are reported on a four point scale: Not at all to To a very large extent. | Measured as change from baseline to 12 months after inclusion | 
| Mean change in patients' satisfaction with involvement of the GP from baseline at 18 months | Patients answer the question To what extent do you experience your GP is sufficiently involved in the follow-up of your health? Answers are reported on a four point scale: Not at all to To a very large extent. | Measured as change from baseline to 18 months after inclusion | 
| Mean change in patients' sense of user involvement from baseline at 6 months | Patients are asked To what extent do you experience that you have opportunity to contribute to your own treatment? Answers are reported on a four point scale: Not at all to To a very large extent. | Measured as change from baseline to 6 months after inclusion | 
| Mean change in patients' sense of user involvement from baseline at 12 months | Patients are asked To what extent do you experience that you have opportunity to contribute to your own treatment? Answers are reported on a four point scale: Not at all to To a very large extent. | Measured as change from baseline to 12 months after inclusion | 
| Mean change in patients' sense of user involvement from baseline at 18 months | Patients are asked To what extent do you experience that you have opportunity to contribute to your own treatment? Answers are reported on a four point scale: Not at all to To a very large extent. | 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 number of appointments with the GP services at baseline is defined as the yearly use 365 days before inclusion. Similarly, the yearly number of appointments with of the GP services at 12 months is defined as the use in the first year after inclusion. The mean change is the primary outcome measure. | Yearly use of the GP services is calculated at baseline and at 12 months after inclusion. | 
| Mean change in the patients' number of outpatient visits from baseline at 12 months | Yearly number of outpatient visits at baseline is defined as the yearly use 365 days before inclusion. Similarly, the yearly number of outpatient visits at 12 months is defined as the use in the first year after inclusion. The mean change is the primary outcome measure. | 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 at baseline is defined as the yearly cost 365 days before inclusion. Similarly, the yearly number of inpatient visits at 12 months is defined as the use in the first year after inclusion. The mean change is the primary outcome measure. | 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 at baseline is defined as the total duration of inpatient visits 365 days before inclusion. Similarly, the total duration of inpatient visits at 12 months is defined as the total duration in the first year after inclusion. The mean change is the primary outcome measure. | 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 at baseline is defined as the yearly use 365 days before inclusion. Similarly, the yearly number of emergency room visits at 12 months is defined as the yearly use in the first year after inclusion. The mean change is the primary outcome measure. | Yearly number of emergency room visits 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 before inclusion is measured as the total number of home nursing visits 30 to 60 days prior to inclusion. Use at 6 months is measured as the total number of home nursing visits 150 to 180 days after inclusion. | Use of home nursing visits is measured one month prior to inclusion and 6 months after inclusion. | 
| Mean change in the patients' number of home nursing visits from baseline at 12 months | Use of home nursing visits before inclusion is measured as the total number of home nursing visits 30 to 60 days prior to inclusion. Use at 12 months is measured as the total number of home nursing visits 335 to 365 days after inclusion. | Use of home nursing visits is measured one month prior to inclusion and 12 months after inclusion. | 
| Mean change in the patients' number of home nursing visits from baseline at 18 months | Use of home nursing visits before inclusion is measured as the total number of home nursing visits 30 to 60 days prior to inclusion. Use at 18 months is measured as the total number of home nursing visits 515 to 545 days after inclusion. | 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 before inclusion is measured as the total duration of home nursing visits 30 to 60 days prior to inclusion. Total duration at 6 months is measured as the total duration of home nursing visits 150 to 180 days after inclusion. | 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 12 months | Total duration of home nursing visits before inclusion is measured as the total duration of home nursing visits 30 to 60 days prior to inclusion. Total duration at 12 months is measured as the total duration of home nursing visits 335 to 365 days after inclusion. | Total duration of home nursing visits is measured one month prior to inclusion and 12 months after inclusion. | 
| Mean change in the patients' duration of home nursing visits from baseline at 18 months | Total duration of home nursing visits before inclusion is measured as the total duration of home nursing visits 30 to 60 days prior to inclusion. Total duration at 18 months is measured as the total duration of home nursing visits 515 to 545 days after inclusion. | 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 6 months | Use of municipal emergency day care unit visits before inclusion is measured as the total number of municipal emergency day care unit visits 30 to 60 days prior to inclusion. Use at 6 months is measured as the total number of municipal emergency day care unit visits 150 to 180 days after inclusion. | 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 12 months | Use of municipal emergency day care unit visits before inclusion is measured as the total number of municipal emergency day care unit visits 30 to 60 days prior to inclusion. Use at 12 months is measured as the total number of municipal emergency day care unit visits 335 to 365 days after inclusion. | 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 municipal emergency day care unit visits from baseline at 18 months | Use of municipal emergency day care unit visits before inclusion is measured as the total number of municipal emergency day care unit visits 30 to 60 days prior to inclusion. Use at 18 months is measured as the total number of municipal emergency day care unit visits 515 to 545 days after inclusion. | Use of municipal emergency day care unit visits is measured one month prior to inclusion and 18 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 before inclusion is measured as the total duration of municipal emergency day care unit visits 30 to 60 days prior to inclusion. Total duration at 6 months is measured as the total duration of municipal emergency day care unit visits 150 to 180 days after inclusion. | 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 12 months | Total duration of municipal emergency day care unit visits before inclusion is measured as the total duration of municipal emergency day care unit visits 30 to 60 days prior to inclusion. Total duration at 12 months is measured as the total duration of municipal emergency day care unit visits 335 to 365 days after inclusion. | Total duration of municipal emergency day care unit 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 18 months | Total duration of municipal emergency day care unit visits before inclusion is measured as the total duration of municipal emergency day care unit visits 30 to 60 days prior to inclusion. Total duration at 18 months is measured as the total duration of municipal emergency day care unit visits 515 to 545 days after inclusion. | Total duration of municipal emergency day care unit visits is measured one month prior to inclusion and 18 months after inclusion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, telehealth, randomized control trial, chronic disease, health services research, primary health care, primary care nursing