NCT04142710

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 732 (actual)
• Sponsor: University of Oslo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Disease
• Diabetes
• Vascular Diseases
• Chronic Lung Disease
• Cancer
• Psychiatric Disorder

Interventions

Type	Name	Description
DEVICE	Telemedicine: tablet and possibly tools to perform measurements	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.

Timeline

• Start date: 2019-02-09
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2019-10-29
• Last updated: 2021-10-07

Locations

9 sites across 1 country: Norway