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

University of Oslo

Status: Completed

Conditions: Chronic Lung Disease; Psychiatric Disorder; Diabetes; Chronic Disease; Cancer; Vascular Diseases

Treatments: Device: Telemedicine: tablet and possibly tools to perform measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT04142710

Medisinsk avstandsoppfølging

Details and patient eligibility

About

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.

Enrollment: 732 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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732 participants in 3 patient groups

Follow-up using telehealth solutions

Experimental group

Description:

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.

Treatment:

Device: Telemedicine: tablet and possibly tools to perform measurements

Standard clinical care

No Intervention group

Description:

Participants in this arm receive standard clinical care in accordance with their medinal needs.

Non-randomized follow-up using telehealth solutions

Experimental group

Description:

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.

Treatment:

Device: Telemedicine: tablet and possibly tools to perform measurements