Chronic DiseaseMAONCT04142710
Pragmatic Randomized Control Trial of Telehealth vs Standard Care in Follow-up of Patients With Chronic Conditions
A study testing Telemedicine: tablet and possibly tools to perform measurements in people with Chronic Disease and Diabetes, run by University of Oslo at 9 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Diabetes, Vascular Diseases
- What is being tested?
- Telemedicine: tablet and possibly tools to perform measurements
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- 9 sitesNorway
- Study dates
- 9 Feb 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
Norway9 sites
Bodø municipality
Bodø
Eid municipality
Eidfjord
Ullensaker municipality
Jessheim
Kristiansand municipality
Kristiansand
Larvik municipality
Larvik
Gamle Oslo district, Oslo
Oslo
Grünerløkka district, Oslo
Oslo
Sagene ditrict, Oslo
Oslo
St.Hanshaugen district, Oslo
Oslo
About this study
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
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.
Read more
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
- Being tested
- Telemedicine: tablet and possibly tools to perform measurements
- Keywords
- telemedicine, telehealth, randomized control trial, chronic disease, health services research, primary health care, primary care nursing
- Medical subject headings
- Chronic Disease, Diabetes Mellitus, Vascular Diseases, Neoplasms, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine: tablet and possibly tools to perform measurementsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Telemedicine: tablet and possibly tools to perform measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: 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: 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: 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: 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: 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.
Measured: 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
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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Total duration of municipal emergency day care unit visits is measured one month prior to inclusion and 18 months after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start9 Feb 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 732 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Economics, Norwegian Centre for Rural Medicine, Norsk Gallup Institutt AS
- Responsible party
- Principal investigator, Tor Iversen, University of Oslo
- Investigators
- Tor Iversen, Professor, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142710
- Sponsor's protocol ID
- Medisinsk avstandsoppfølging
- Acronym
- MAO
- Status last verified
- Oct 2021
- First submitted
- 5 Jul 2019
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers are not allowed to share individual patient data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04142710
- Acronym / sponsor ID
- MAO / Medisinsk avstandsoppfølging
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 732 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo Economics, Norwegian Centre for Rural Medicine, Norsk Gallup Institutt AS
- Study start
- 9 Feb 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Follow-up using telehealth solutions | Experimental | Device: Telemedicine: tablet and possibly tools to perform measurementsParticipants 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. |
| 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 | Device: Telemedicine: tablet and possibly tools to perform measurementsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine: tablet and possibly tools to perform measurementsUsers 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. | Device | Follow-up using telehealth solutions, Non-randomized follow-up using telehealth solutions |
Primary outcome
Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 6 months
Time frame: Measured as change from baseline to 6 months after inclusion
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.
Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 12 months
Time frame: Measured as change from baseline to 12 months after inclusion
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.
Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 18 months
Time frame: Measured as change from baseline to 18 months after inclusion
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.
Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 6 months
Time frame: Measured as change from baseline to 6 months after inclusion
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.
Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 12 months
Time frame: Measured as change from baseline to 12 months after inclusion
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.
Mean change in health-related quality of life (Visual Analogue Scale (VAS)) from baseline at 18 months
Time frame: Measured as change from baseline to 18 months after inclusion
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.
Mean change in overall satisfaction with treatment and follow-up from baseline at 6 months
Time frame: Measured as change from baseline to 6 months after inclusion
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"
Mean change in overall satisfaction with treatment and follow-up from baseline at 12 months
Time frame: Measured as change from baseline to 12 months after inclusion
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"
Mean change in overall satisfaction with treatment and follow-up from baseline at 18 months
Time frame: Measured as change from baseline to 18 months after inclusion
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"
Change in yearly health and care cost per person from baseline at 12 months
Time frame: Yearly health and care cost per person is calculated at baseline and at 12 months after inclusion.
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.
29 secondary outcomes
Mean change in sleep quality from baseline at 6 months
Time frame: Measured as change from baseline to 6 months after inclusion
Mean change in sleep quality from baseline at 12 months
Time frame: Measured as change from baseline to 12 months after inclusion
Mean change in sleep quality from baseline at 18 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured as change from baseline to 18 months after inclusion
Mean change in patients' sense of user involvement from baseline at 6 months
Time frame: Measured as change from baseline to 6 months after inclusion
Mean change in patients' sense of user involvement from baseline at 12 months
Time frame: Measured as change from baseline to 12 months after inclusion
Mean change in patients' sense of user involvement from baseline at 18 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Total duration of municipal emergency day care unit visits is measured one month prior to inclusion and 18 months after inclusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: No. Researchers are not allowed to share individual patient data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tor Iversen, Professor principal investigator
University of Oslo
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine: tablet and possibly tools to perform measurements in people with Chronic Disease and Diabetes, run by University of Oslo at 9 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in health-related quality of life (EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)) from baseline at 6 months (time frame: Measured as change from baseline to 6 months after inclusion). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.