Clinical trial: NCT04142710
Section: Confidentiality
Subsections: What Happens To The Information About You?

The information recorded about you will be used as described above. You have the right to access the information that is registered about you and the right to correct any errors in the information that is registered. All information will be processed without name and birth number or any other directly recognizable information. A code links you to your information through a link key. Information obtained is stored on a secure data server. Audio recordings are stored in a locked safe, and notes are stored in a workbook that only the research group has access to on the Oslo Economics network. The project is scheduled to end on 31 December 2024, and audio recordings and information collected will be deleted within three years of the end of the project (by 31 December 2027). Information recorded about you by the employees in your municipality can be used for internal quality assurance in the municipality.
Clinical trial: NCT04142710
Section: Participant Responsibilities
Subsections: What Does Participation Mean To You?

- As a participant in the trial, you will be asked to complete a short questionnaire up to four times over 18 months, regardless of whether you are part of the group that receives follow-up using telehealth solutions or the control group. Your questionnaire responses are recorded electronically or on paper. In addition, some users will be asked to be interviewed by the researchers. It will take approximately one hour, and audio recordings and notes will be taken from the interviews.  
- We will collect and record information about you from various local and national registers. All data will be de-identified, and results will be presented at group level. This means that you will not be able to recognize data that is being analyzed or presented. Table 1 (p. 4) gives an overview of what types of information are collected about you and from which registers.  
- The purpose of the data collection is to investigate whether your state of health, experience and use of health services has changed during the trial period. This knowledge will help to further develop and improve the Norwegian health service.
Clinical trial: NCT04142710
Section: Participant's Rights
Subsections: Your Rights

As long as you can be identified in the data material, you are entitled to:
- insight into what personal information is registered about you, - obtaining personal information about you, - to delete personal information about you, - obtain a copy of your personal data (data portability), and - to submit a complaint to the Privacy Ombudsman or the Data Inspectorate regarding the processing of your personal data.
Clinical trial: NCT04142710
Section: Procedures
Subsections: More About The Testing

The Directorate of Health has been commissioned by the Ministry of Health and Care Services to conduct a trial of medical distance monitoring in the period 2018-2021. The University of Oslo, Oslo Economics and the National Center for District Medicine are responsible for the research. In practice, distance monitoring means that you as a user answer health-related questions on a tablet and/or record measurements related to your health (e.g. blood pressure, blood sugar, oxygen measurement). The information is sent electronically to a follow-up service, where health professionals monitor the measurements and follow you up in accordance with a treatment plan that your GP has prepared in consultation with you. The equipment is easy to use, and you get training at startup. The purpose of the trial is to find out how distance follow-up affects the physical and mental health of users, user experience and use of resources in the health service. We will also examine how the service is delivered, and assess the costs and benefits of distance follow-up, both for the users, the health service and society as a whole. The Directorate of Health will use the results of the research as the basis for national recommendations on distance followup.  
In order to establish knowledge about the effect of distance follow-up compared to current practice, the test is conducted as a randomized controlled trial in selected municipalities. This means that half of those who agree to participate in the trial receive distance follow-up (socalled 'action group') while the other half receive regular follow-up from the health service
(so-called 'control group'). It is a coincidence which group you end up in (is determined by lottery). To investigate the effect of distance monitoring on participants' consumption of health services in both the short and long term, we will collect and record information about you from various local and national registries in the period from 2017 to 2022. If your municipality continues the offer with distance follow-up after the end of the follow-up period (18 months), participants in both the action and control group will have the opportunity to be considered for distance follow-up.
Clinical trial: NCT04142710
Section: Voluntary Participation
Subsections: Participation In The Trial Of Telehealth

This Statement is for your consent to participate in a trial of medical distance follow-up. The purpose of the trial is to find out how telehealth affects health, experience of the health service and consumption of health services. Participation is voluntary. You can withdraw your consent at any time. Below you can read more about the trial and what participation means to you and give your consent if you accept the invitation to participate.