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

NCT04142710 | Completed

• 1 other identifier: Medisinsk avstandsoppfølging
• Study Type: interventional
• Target: 732
• Locations: 1 country
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (29)

• 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 12 months

  Measured as change from baseline to 12 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 6 months

  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

  Measured as change from baseline to 12 months after inclusion

Study Arms (3)

Follow-up using telehealth solutions

EXPERIMENTAL

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

Standard clinical care

NO INTERVENTION

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

Non-randomized follow-up using telehealth solutions

EXPERIMENTAL

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

Interventions

Telemedicine: tablet and possibly tools to perform measurements DEVICE

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.

Follow-up using telehealth solutions; Non-randomized follow-up using telehealth solutions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead
• Oslo Economics: collaborator
• Norwegian Centre for Rural Medicine: collaborator
• Norsk Gallup Institutt AS: collaborator

Study Sites (9)

Bodø municipality

Bodø, Norway

Location

Eid municipality

Eidfjord, Norway

Location

Ullensaker municipality

Jessheim, Norway

Location

Kristiansand municipality

Kristiansand, Norway

Location

Larvik municipality

Larvik, Norway

Location

Gamle Oslo district, Oslo

Oslo, Norway

Location

Grünerløkka district, Oslo

Oslo, Norway

Location

Sagene ditrict, Oslo

Oslo, Norway

Location

St.Hanshaugen district, Oslo

Oslo, Norway

Location

MeSH Terms

Conditions

Chronic Disease; Diabetes Mellitus; Vascular Diseases; Neoplasms; Mental Disorders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases

Study Officials

• Tor Iversen, Professor

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Economics

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: October 29, 2019
• Study Start: February 9, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (9)