Clinical trial NCT04142710: Pragmatic Randomized Control Trial of Telehealth vs Standard Care in Follow-up of Patients With Chronic Conditions
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Diabetes
Vascular Diseases
Chronic Lung Disease
Cancer
Psychiatric Disorder
Keywords: telemedicine
telehealth
randomized control trial
chronic disease
health services research
primary health care
primary care nursing
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo Economics
name: Norwegian Centre for Rural Medicine
name: Norsk Gallup Institutt AS
First posted: 2019-10-29
Enrollment: 732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 6 months
timeFrame: Measured as change from baseline to 6 months after inclusion
measure: Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 12 months
timeFrame: Measured as change from baseline to 12 months after inclusion
measure: Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 18 months
timeFrame: Measured as change from baseline to 18 months after inclusion
measure: Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 6 months
timeFrame: Measured as change from baseline to 6 months after inclusion
measure: Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 12 months
timeFrame: Measured as change from baseline to 12 months after inclusion
measure: Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 18 months
timeFrame: Measured as change from baseline to 18 months after inclusion
measure: Mean change in overall satisfaction with treatment and follow-up from baseline at 6 months
timeFrame: Measured as change from baseline to 6 months after inclusion
measure: Mean change in overall satisfaction with treatment and follow-up from baseline at 12 months
timeFrame: Measured as change from baseline to 12 months after inclusion
measure: Mean change in overall satisfaction with treatment and follow-up from baseline at 18 months
timeFrame: Measured as change from baseline to 18 months after inclusion
measure: Change in yearly health and care cost per person from baseline at 12 months
timeFrame: Yearly health and care cost per person is calculated at baseline and at 12 months after inclusion.
Secondary outcomes:
measure: Mean change in sleep quality from baseline at 6 months
timeFrame: Measured as change from baseline to 6 months after inclusion
measure: Mean change in sleep quality from baseline at 12 months
timeFrame: Measured as change from baseline to 12 months after inclusion
measure: Mean change in sleep quality from baseline at 18 months
timeFrame: Measured as change from baseline to 18 months after inclusion
measure: Mean change in patients' sense of control over their health situation from baseline at 6 months
timeFrame: Measured as change from baseline to 6 months after inclusion
measure: Mean change in patients' sense of control over their health situation from baseline at 12 months
timeFrame: Measured as change from baseline to 12 months after inclusion
measure: Mean change in patients' sense of control over their health situation from baseline at 18 months
timeFrame: Measured as change from baseline to 18 months after inclusion
measure: Mean change in patients' satisfaction with involvement of the GP from baseline at 6 months
timeFrame: Measured as change from baseline to 6 months after inclusion
measure: Mean change in patients' satisfaction with involvement of the GP from baseline at 12 months
timeFrame: Measured as change from baseline to 12 months after inclusion
measure: Mean change in patients' satisfaction with involvement of the GP from baseline at 18 months
timeFrame: Measured as change from baseline to 18 months after inclusion
measure: Mean change in patients' sense of user involvement from baseline at 6 months
timeFrame: Measured as change from baseline to 6 months after inclusion
measure: Mean change in patients' sense of user involvement from baseline at 12 months
timeFrame: Measured as change from baseline to 12 months after inclusion
measure: Mean change in patients' sense of user involvement from baseline at 18 months
timeFrame: Measured as change from baseline to 18 months after inclusion
measure: Mean change in the patients' number of appointments with the GP services from baseline at 12 months
timeFrame: Yearly use of the GP services is calculated at baseline and at 12 months after inclusion.
measure: Mean change in the patients' number of outpatient visits from baseline at 12 months
timeFrame: Yearly number of outpatient visits is calculated at baseline and at 12 months after inclusion.
measure: Mean change in the patients' number of inpatient visits from baseline at 12 months
timeFrame: Yearly number of inpatient visits is calculated at baseline and at 12 months after inclusion.
measure: Mean change in the patients' duration of inpatient visits from baseline at 12 months
timeFrame: Total duration of inpatient visits is calculated at baseline and at 12 months after inclusion.
measure: Mean change in the patients' number of emergency room visits from baseline at 12 months
timeFrame: Yearly number of emergency room visits is calculated at baseline and at 12 months after inclusion.
measure: Mean change in the patients' number of home nursing visits from baseline at 6 months
timeFrame: Use of home nursing visits is measured one month prior to inclusion and 6 months after inclusion.
measure: Mean change in the patients' number of home nursing visits from baseline at 12 months
timeFrame: Use of home nursing visits is measured one month prior to inclusion and 12 months after inclusion.
measure: Mean change in the patients' number of home nursing visits from baseline at 18 months
timeFrame: Use of home nursing visits is measured one month prior to inclusion and 18 months after inclusion.
measure: Mean change in the patients' duration of home nursing visits from baseline at 6 months
timeFrame: Total duration of home nursing visits is measured one month prior to inclusion and 6 months after inclusion.
measure: Mean change in the patients' duration of home nursing visits from baseline at 12 months
timeFrame: Total duration of home nursing visits is measured one month prior to inclusion and 12 months after inclusion.
measure: Mean change in the patients' duration of home nursing visits from baseline at 18 months
timeFrame: Total duration of home nursing visits is measured one month prior to inclusion and 18 months after inclusion.
measure: Mean change in the patients' number of municipal emergency day care unit visits from baseline at 6 months
timeFrame: Use of municipal emergency day care unit visits is measured one month prior to inclusion and 6 months after inclusion.
measure: Mean change in the patients' number of municipal emergency day care unit visits from baseline at 12 months
timeFrame: Use of municipal emergency day care unit visits is measured one month prior to inclusion and 12 months after inclusion.
measure: Mean change in the patients' number of municipal emergency day care unit visits from baseline at 18 months
timeFrame: Use of municipal emergency day care unit visits is measured one month prior to inclusion and 18 months after inclusion.
measure: Mean change in the patients' duration of municipal emergency day care unit visits from baseline at 6 months
timeFrame: Total duration of municipal emergency day care unit visits is measured one month prior to inclusion and 6 months after inclusion.
measure: Mean change in the patients' duration of municipal emergency day care unit visits from baseline at 12 months
timeFrame: Total duration of municipal emergency day care unit visits is measured one month prior to inclusion and 12 months after inclusion.
measure: Mean change in the patients' duration of municipal emergency day care unit visits from baseline at 18 months
timeFrame: Total duration of municipal emergency day care unit visits is measured one month prior to inclusion and 18 months after inclusion.
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Bodø municipality
city: Eidfjord
country: Norway
facility: Eid municipality
city: Jessheim
country: Norway
facility: Ullensaker municipality
city: Kristiansand
country: Norway
facility: Kristiansand municipality
city: Larvik
country: Norway
facility: Larvik municipality
city: Oslo
country: Norway
facility: Gamle Oslo district, Oslo
city: Oslo
country: Norway
facility: Grünerløkka district, Oslo
city: Oslo
country: Norway
facility: Sagene ditrict, Oslo
city: Oslo
country: Norway
facility: St.Hanshaugen district, Oslo
Study officials:
affiliation: University of Oslo
name: Tor Iversen, Professor
role: PRINCIPAL_INVESTIGATOR
References: