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
Phase: NA
Conditions: Chronic Disease, Diabetes, Vascular Diseases, Chronic Lung Disease, Cancer, Psychiatric Disorder
Sponsor: University of Oslo

 
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 
Short title: Pragmatic RCT of telehealth vs standard care in follow-up of patients with chronic conditions 
 
Date: July 2nd 2019 
Name 
Telephone 
E-mail 
Visiting address Mailing 
address 
Project Leader 
Tor Iversen +47 22 84 50 32 tor.iversen@medisin.uio.no 
Forskningsveien 3A
0373 Oslo, 
Norway 
Postboks 
1089 Blindern 
0317 Oslo, 
Norway  
Project Manager 
Susanna  
Sten-
Gahmberg 
+47 45 13 41 35 ssg@osloeconomics.no 
Kronprinsesse  
Märthas plass 1 
0160 Oslo, 
Norway 
Postboks 
1562 
Vika 
0118 Oslo, 
Norway 
The Norwegian 
Directorate of 
Health  
Siw  
Helene  
Myhrer 
+47 90 67 91 53 siw.helene.myhrer@helsedir.no
Vitaminveien 4 
0483 Oslo, 
Norway 
Postboks 220 
Skøyen, 0213 
Oslo, Norway 
 
 
 
Contact information 

 
Title of the study 
A pragmatic randomized control trial comparing telehealth with standard 
clinical care in the follow-up of patients with chronic conditions 
Short title 
Pragmatic RCT of telehealth vs standard care in follow-up of patients with 
chronic conditions 
Treatment 
 
Control treatment 
Standard clinical care 
Study centers planned 
The following six municipalities are included in the study: Oslo, Eid, Kristiansand 
(recruiting from the Agder counties), Ullensaker (in cooperation with Gjerdrum), 
Larvik and Bodø 
Study period 
First patient recruited: February 19th, 2019  
Anticipated recruitment period: February 1st, 2019 to June 30th, 2020 
Estimated date of last patient completed: June 30th, 2021 
 
Treatment duration 
Patients in the intervention group will be followed up using telehealth solutions 
for 12 – 18 months 
Patients in the control group receive standard clinical care throughout the study 
period 
Study objectives 
Primary: 
1. To assess whether patients who are followed up using telehealth 
experience an improved health state (or lower reduction in health 
state for patients with deteriorating health) compared to patients 
receiving standard clinical care. 
2. To assess whether patients who are followed up using telehealth are 
more satisfied with the health care services than patients receiving 
standard clinical care. 
3. To assess whether patients who are followed up using telehealth 
utilize less healthcare resources than patients receiving standard 
clinical care    
Exploratory:  
1. To evaluate the organization of the service 
2. To evaluate the cost-effectiveness of telehealth compared to standard 
clinical care 
Study endpoints 
Primary endpoints:  
• 
Health related quality of life (EQ-5D) 
• 
Overall satisfaction with treatment and follow-up  
• 
Health and care cost per person 
Secondary endpoints: 
• 
Physical functioning  
• 
Sleep 
• 
Coping 
Protocol synopsis 

 
• 
Satisfaction with the telehealth technology (only in the intervention 
group) 
• 
Satisfaction with health care personnel 
• 
Patient involvement 
• 
Perceived benefits 
• 
Use of health and care services 
Exploratory endpoints:  
• 
Describe and evaluate the service: organization, cooperation between 
health and care providers, user involvement, technological solutions 
 
• 
Summarize costs and benefits of the intervention and comparator 
strategy 
• 
Evaluate cost-effectiveness 
• 
Compare cost-effectiveness across local projects 
Study design and 
description 
A randomized, open, controlled, multicenter, pragmatic comparative study 
Study population 
Norwegian adult male and female patients (aged >=18 years) with chronic 
conditions, with medium to high risk of worsening of their condition, 
hospitalization or increased need for health and care services. Although the 
inclusion criteria do not restrict to specific diseases or conditions, examples of 
relevant patient groups include; patients with chronic conditions, mental illness, 
physical disabilities, and cancer patients. 
Main inclusion criteria 
• 
>18 years of age 
• 
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 
Main exclusion criteria 
• 
Patients who are not competent to consent 
• 
Patients who are unable to handle the tablet and the measuring 
equipment to be used 
• 
Patients with substance abuse 
Sample size 
600 patients are planned to be recruited. The sample size was decided by the 
Norwegian Directorate of Health. 
Randomization procedure 
Eligible patients are allocated in a 1:1 ratio between telehealth and standard 
clinical care, using sealed paper-based envelopes with a note that states either 
“intervention group” or “control group”.  
Efficacy assessments 
Efficacy variables include health related quality of life, assessments of patient’s 
own physical and mental health, coping, user experience, resource use  
Safety assessments 
Physical examination and vital signs, record of adverse events, user experience 
Other assessments 
Resource utilization and cost-benefit assessments 
Dara analysis 
The main analysis in planned when all patients have concluded the study, and 
all data have been collected. Preliminary analyses will be conducted, and 
results presented in two midterm reports during the period of the trial. 

 
 
Contact information _______________________________________________________ 1 
Protocol synopsis _________________________________________________________ 2 
Content _________________________________________________________________ 4 
List of abbreviations and definition of terms ___________________________________ 7 
1. Introduction __________________________________________________________ 9 
1.1 Previous evidence on the use of telehealth _______________________________ 9 
1.2 Background for the study ____________________________________________ 9 
1.3 Evaluation of the telehealth trial ______________________________________ 10 
1.4 Organization of the trial ___________________________________________ 11 
1.5 Participating municipalities and scope of the trial ________________________ 11 
2. Study objectives and related endpoints ___________________________________ 11 
3. Study population and study period ______________________________________ 12 
3.1 Inclusion criteria __________________________________________________ 13 
3.2 Exclusion criteria __________________________________________________ 13 
3.3 The number of participants __________________________________________ 14 
3.4 Recruitment of patients _____________________________________________ 14 
4. Treatment – telehealth vs. standard clinical care ____________________________ 14 
4.1 Telehealth _______________________________________________________ 14 
4.2 Standard clinical care _____________________________________________ 15 
5. Recruitment of study participants ________________________________________ 15 
5.1 Step 1: Potential participants are proposed for the trial ___________________ 15 
5.2 Step 2: The GP assesses eligibility ____________________________________ 16 
5.3 Step 3: Patients are invited to participate in the trial _____________________ 16 
5.4 Step 4: Consenting patients are randomized ____________________________ 17 
5.5 Step 5: Assessments of participants ___________________________________ 17 
5.6 After the follow-up period __________________________________________ 18 
5.7 Withdrawal from the intervention and/or the trial ________________________ 18 
5.8 Exceptions from the study procedure: patients enrolled in the previous trial who wishes to continue 
receiving telehealth___________________________________________________ 18 
5.9 Linkage to other registers ___________________________________________ 18 
6. Assessments ________________________________________________________ 19 
6.1 Physical and mental health __________________________________________ 19 
6.2 Patient experience ________________________________________________ 20 
6.3 Use of health and care services ______________________________________ 20 
Content 

 
6.4 Process evaluation ________________________________________________ 21 
6.5 Cost-benefit analysis ______________________________________________ 21 
7. Safety monitoring and reporting _________________________________________ 21 
8. Data Management and monitoring_______________________________________ 21 
8.1 Case report forms (eCRF) ___________________________________________ 22 
8.2 Source data _____________________________________________________ 22 
8.2.1 Data from national administrative health registers _______________________________________ 22 
8.2.2 Data from surveys _______________________________________________________________ 22 
8.2.3 Interviews ______________________________________________________________________ 23 
8.2.4 Data from the follow-up service _____________________________________________________ 24 
8.3 Study monitoring__________________________________________________ 25 
8.4 Confidentiality ___________________________________________________ 25 
8.5 Database management ____________________________________________ 25 
8.6 Collection and storage of data ______________________________________ 26 
9. Statistical method and data analysis _____________________________________ 26 
9.1 Determination of sample size ________________________________________ 26 
9.2 Randomization ___________________________________________________ 27 
9.3 Sample for analysis _______________________________________________ 28 
9.4 Statistical analysis ________________________________________________ 28 
9.5 Analysis of loss-to-follow-up _________________________________________ 29 
10. Study management ___________________________________________________ 29 
10.1 The Norwegian Directorate of Health ________________________________ 29 
10.2 The researchers _________________________________________________ 29 
10.3 The participating municipalities _____________________________________ 29 
10.4 Study amendments _______________________________________________ 29 
10.5 Audit and inspections _____________________________________________ 30 
11. Risk assessment _____________________________________________________ 30 
12. Ethical and regulatory requirements ______________________________________ 30 
12.1 Privacy Policy ___________________________________________________ 30 
12.2 Informed consent procedure ________________________________________ 31 
12.3 Patient Identification _____________________________________________ 31 
12.4 Confidentiality __________________________________________________ 31 
12.5 Ethical committee approval ________________________________________ 31 
12.6 Other regulatory approvals ________________________________________ 31 
13. Trial sponsorship and financing _________________________________________ 31 
14. Publication Policy ____________________________________________________ 31 
15. Overall progress plan _________________________________________________ 32 
References ______________________________________________________________ 33 
Appendix A: Participant consent form________________________________________ 34 

 
Appendix B: Participant questionnaire _______________________________________ 38 
Appendix C: GP questionnaire _____________________________________________ 50 
Appendix D: Follow-up service questionnaire _________________________________ 58 
 
 
 
 

 
Term 
Explanation 
Telehealth 
"Telehealth includes those activities/actions that allow the patient, outside the 
traditional arenas where patients face healthcare professionals, to acquire, 
record and share clinically relevant information about their health status 
electronically, with the purpose of providing information or guidance to the 
patient's self-management, and/or provide decision support for diagnosis, 
treatment or follow-up for health professionals.” (Scottish Center for Telehealth 
& Telecare, 2016) 
Technological solutions allow the health and care service to monitor and follow-
up the patient remotely. Users of telehealth can answer simple questions about 
their health condition and/or perform agreed 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 service 
The follow-up service is the center that receives and follows the measurements 
from the patients who receive telehealth. The municipalities are free to organize 
the follow-up service according to local needs, but it is required that the 
employees have nursing competence. The follow-up service may be co-located 
with other municipal services such as home nursing or the emergency room 
service. In municipalities that have multidisciplinary care teams, the nurse in the 
multidisciplinary care team may follow-up the patients using telehealth. 
User 
A user is a patient who receives telehealth. 
Participant 
A participant is a patient who is included in the clinical trial of telehealth - either 
in the intervention group or the control group. 
Trial 
Trial refers to the research-based evaluation and pragmatic randomized-
controlled trial comparing telehealth with standard clinical care, initiated by the 
Norwegian Directorate of Health in 2018. The trial is carried out at six local 
centers.  
Project 
Project refers to one of the six local trials of telehealth. The projects receive co-
financing from the Norwegian Directorate of Health in order to carry out the 
trial of telehealth in line with the Directorate of Health's guidelines. 
Evaluation 
Evaluation refers to the research-based evaluation of the trial. The Directorate 
of Health has commissioned an evaluation of the trial. The evaluation 
constellation includes researchers from the Institute of Health and Society at the 
University of Oslo, Oslo Economics and the Norwegian Centre for Rural 
Medicine (NCRM) at UiT - the Arctic University of Norway, Tromsø. The purpose 
List of abbreviations and definition of terms 

 
of the evaluation is to estimate the effects of telehealth within a primary care 
setting on the users' health status, the user’s experience with the service and 
healthcare resource utilization. The aim of the evaluation is to inform the 
decision about whether and how to implement telehealth as part of primary 
care services in Norway. 
 
 
 

 
The Norwegian health authorities has initiated a three-year trial of telehealth as part of the treatment of patients 
with chronic illness in the period 2018-2021 (Helsedirektoratet, 2018). Within the trial, telehealth indicates that 
patients (or ‘users of healthcare’, herein referred to as ‘users’) are followed-up outside health-care facilities using 
information and communication technologies (ICTs), so-called “welfare technological solutions”. Users receiving 
telehealth 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 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. 
A consortium of researchers from the Institute of Health and Society at the University of Oslo, Oslo Economics and 
the Norwegian Centre for Rural Medicine (NCRM) at UiT - the Arctic University of Norway has been engaged by 
the Norwegian Directorate of Health to evaluate the effects of the trial.  
The evaluation includes three main parts: 1) An effect evaluation, 2) a cost-benefit analysis, and 3) a process 
evaluation which aims to provide recommendations for how to organize and implement telehealth in clinical 
practice. The main effect outcomes include physical and mental health, patient experience and use of health 
services. 
1.1 Previous evidence on the use of telehealth 
There is a large literature that studies the effects of telehealth on patient outcomes. One challenge related to this 
literature is the extent of variation in the existing studies. Studies vary in the type and design of telehealth 
solution, in the study population, in the endpoints studied, in the design and quality of the study, among other 
things. This makes comparisons and generalizations of studies and findings challenging.  
The evidence on clinical outcomes are mixed, but some general patterns emerge. Numerous studies, systematic 
reviews and reviews of reviews suggest that there are positive effects on clinical outcomes in treatment of chronic 
diseases. For example, an evidence mapping prepared for the U.S. Department of Health and Human Services 
(Totten, et al., 2016), found that a large body of research found positive patient outcomes for remote patient 
monitoring for several chronic conditions. The most consistent finding of this evidence mapping was the 
effectiveness of telehealth when used for communication and counseling or remote monitoring for chronic 
conditions such as cardiovascular disease and respiratory disease, showing improvements in i.e., mortality and 
quality of life and reductions in hospital admissions.  
The evidence related to costs and resource utilization is even more mixed. There are several potential 
explanations for this. One is that costs may be more easily affected by the type of telehealth intervention, by the 
organization and financing of the health service. This also provides extra challenges for researchers who are to 
conduct systematic reviews, resulting in fewer systematic reviews of the cost-effectiveness of telehealth. The 
evidence mapping mentioned above found fewer positive results for cost and utilization of health care services. 
15 of 32 systematic reviews that reported on cost/utilization found a benefit or a potential benefit from 
telehealth. Most of these focused on remote patient monitoring. For other types of telehealth, the no or limited 
evidence of reductions in cost of utilization of health services. 
A more extensive literature review on the effects of telehealth in the primary care service on patient outcomes will 
be delivered by the Norwegian Institute of Public Health to the NDH by the end of 2019. 
1.2 Background for the study 
Norway has an ageing population, and the need for health and care services will likely increase in the coming 
years. There is a need for innovation to face these challenges. Technology is one of the pillars of the future health 
1. Introduction 

 
and care service, and the evaluation of telehealth will help inform how technology can be used as a tool for 
follow-up in patient trajectories. 
During the period 2016-2018, the Norwegian Directorate of Health conducted an initial trial of welfare 
technology solutions for telehealth (Intro International, 2018). A total of 822 people in seven projects in four 
municipalities participated in the trial. The study population included people with chronic conditions, and primarily 
people with COPD, diabetes and heart failure. The study showed that the users were satisfied with the 
intervention. However, due to the lack of a control group in the trial, it was not possible to draw conclusions about 
health effects and costs. Although the trial provided useful insight to the potential value of telehealth, the study 
did not provide enough evidence on the effects to inform national recommendations. Thus, there is a need for 
more knowledge about the effects and consequences of telehealth for all the actors involved, i.e. both patients 
and service providers. 
The Norwegian Directorate of Health has therefore initiated a new trial, conducted as a pragmatic randomized 
control trial, of telehealth for people with chronic disease. The trial is carried out in the period 2018 - 2021 and 
is part of the National Welfare Technology Program (Nasjonalt Velferdsteknologiprogram). 2018 involved 
recruitment of local centers to participate in the trial as well as planning and study design. The first patients are 
recruited to the trial in 2019. The purpose for the new trial, as defined by the Norwegian Directorate of Health, 
is to obtain knowledge about the effects of telehealth that can inform recommendations for national 
implementation. The intervention is described in more detail in Section 4. 
1.3 Evaluation of the telehealth trial 
On behalf of the Norwegian Directorate of Health, the research consortium will evaluate the telehealth trial using 
a mixed-methods approach, with three main evaluation components: 1) effect evaluation, aimed at measuring the 
effect of telehealth on the users' health status, patient experience and resource utilization in the healthcare 
system; 2) process evaluation, aimed at evaluating the organization of the service, collaboration and interaction 
between different actors; and 3) cost-benefit analysis, aimed at comparing health benefits and costs of telehealth 
compared to standard clinical care (Figure 1).  
The evaluation is based on a wide range of data sources, including repeated surveys and interviews with patients 
and health personnel in various parts of the health service. Registry data will also be obtained on the use of 
health services within both the municipal health and care service, the GP service and the specialist health service. 
In addition, data from the follow-up service will be analyzed if available. 
Figure 1: Evaluation of trial of telehealth 
 

 
1.4 Organization of the trial 
The Norwegian Directorate of Health has initiated the trial and is responsible for its implementation. The 
Norwegian Directorate of Health has designed the scope of the trial, including central elements of the 
intervention, such as main features of the intervention, study population, inclusion and exclusion criteria, 
organization of the service, overall outcome measures, study duration and number of participants. When 
designing the scope of the trial, the Norwegian Directorate of Health has involved participants in the previous 
trial, as well as representatives for various stake holders, such as patient associations and health care providers 
and municipalities. The Norwegian Directorate of Health is also responsible for recruiting the participating 
municipalities, and for providing guidance to these local projects regarding practical implementation of the 
telehealth.  
The Norwegian Directorate of Health is also the principal for the evaluation. The evaluation is carried out by a 
constellation of researchers at the University of Oslo, Oslo Economics and the National Center for District Medicine 
(hereafter referred to as the research consortium). The researchers are responsible for the development of the 
evaluation design within the scope of the trial set by the Norwegian Directorate of Health, data collection and 
management and statistical method and data analysis. The Norwegian Directorate of Health will not have access 
to the raw data material but will receive summarized reports with results along the way and after the trial has 
ended. 
1.5 Participating municipalities and scope of the trial 
The trial of telehealth is conducted at a total of six local centers. The participating centers are situated in the 
municipalities of Eid, Bodø, Larvik, Oslo (in the districts of Sagene, Grünerløkka, Gamle Oslo, St. Hanshaugen), 
Ullensaker (in cooperation with Gjerdrum) and Kristiansand. Kristiansand municipality is leading a local center 
recruiting patients from 30 municipalities in the Agder county. 
Eid municipality, as well as a general practitioner office in Kristiansand and one in the Sagene district also 
participate in the pilot study of multidisciplinary care teams within primary care. The Norwegian Directorate of 
Health has asked the research consortium to evaluate synergies between the two trials. However, the telehealth 
trial is not designed to explicitly examine the effect of participating in both studies, as this was not possible within 
the frames given by the Norwegian Directorate of Health. Instead, synergies will be investigated through 
interviews. 
The local centers carry out the trial in line with the guidelines from the Norwegian Directorate of Health. The 
centers also undertake to follow the study protocol for the trial. It is the centers’ responsibility to recruit 
participants to the trial. 
As described above, the evaluation of telehealth consists of three main parts: 1) an effect evaluation, 2) a process 
evaluation, and 3) a cost-benefit analysis. The effect study is designed as a randomized, non-blinded, controlled 
study conducted at six local centers in Norway. The telehealth trial and the related evaluation will provide more 
knowledge about effects, benefits and costs, as well as highlight how telehealth can contribute to fulfilling 
national goals for the primary health service as stated in Report No. 26 (2014-2015) to the Storting (Meld. St. 
26, 2014–2015) and the Government report Omsorg 2020 [Care 2020] (Helse- og omsorgsdepartementet, 
2015). The results from the evaluation will inform recommendations on the national implementation of telehealth. 
Table 1: Study objectives and related endpoints 
 
Objectives 
Outcomes 
Assessments 
Primary 
To assess whether patients who are 
followed up using telehealth 
experience an improved health state 
(or lower reduction in health state for 
patients with deteriorating health) 
Primary 
• 
Health related quality of life 
(EQ-5D) 
Secondary 
• 
Physical functioning  
• 
Sleep 
Section 6.1 
2. Study objectives and related endpoints 

 
compared to patients receiving 
standard clinical care. 
• 
Coping 
Primary 
To assess whether patients who are 
followed up using telehealth are more 
satisfied with the health care services 
than patients receiving standard clinical 
care.  
Primary 
• 
Overall satisfaction with 
treatment and follow-up  
Secondary 
• 
Satisfaction with the telehealth 
technology (only in the 
intervention group) 
• 
Satisfaction with health care 
personnel 
• 
Patient involvement 
• 
Perceived benefits 
Section 6.2 
Primary 
To assess whether patients who are 
followed up using telehealth utilize less 
healthcare resources than patients 
receiving standard clinical care    
Primary 
• 
Health and care cost per 
person 
Secondary 
• 
Use of health and care services  
Section 6.3 
Explanatory 
To evaluate the organization of the 
service 
• 
Describe and evaluate the 
service: organization, 
cooperation between health 
and care providers, user 
involvement, technological 
solutions 
Section 6.4 
Explanatory 
To evaluate the cost-effectiveness of 
telehealth compared to standard 
clinical care 
• 
Summarize costs and benefits 
of the intervention and 
comparator strategy 
• 
Evaluate cost-effectiveness 
• 
Compare cost-effectiveness 
across local projects 
Section 6.5 
 
The target population includes people with chronic diseases, with a medium to high risk of worsening their 
condition, re-admission to hospital or an increased need for health and care services. The inclusion criteria are set 
by the Norwegian Directorate of Health. Patients who meet the inclusion criteria and who consent to participation 
are randomized 1:1 in accordance with the procedure described in Section 5. Patients in the intervention group 
receives follow-up using telehealth (which is described in more detail in Chapter 4), while patients in the control 
group receive standard clinical care.  
Testing Period: 
• 
Date for inclusion of first patient: February 2019 
• 
Expected recruitment period: February 2019 to June 2020 
• 
Expected closing date for follow-up of last patient June 2021 
Follow-up period: 12 to 18 months 
3. Study population and study period 

 
3.1 Inclusion criteria 
The primary inclusion criterion is that the individual has a considerable disease burden and comprehensive 
medical needs. Thus, the target population for the trial is patients with chronic diseases, with medium to high risk 
of worsening of their condition, hospitalization or increased need for health and care services. These patients are 
characterized by a high consumption of healthcare services (such as hospital services, regular medical services, 
and home services, or a combination of these) and are largely composed of patients with non-infectious chronic 
diseases such as diabetes, COPD, cardiovascular disease, mental illness and cancer. These patients often have 
comorbidities and comprehensive medical needs. Only adults, aged 18 or older, can be included in the trial.  
Specific inclusion criteria include: 
• 
>18 years of age 
• 
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 
For each potential participant, the patient’s GP evaluates whether these criteria are met.  
Figure 2 illustrates groups of the population with different needs for health and care services, and the figure can 
be used to illustrate which groups should be included in the trial. The previous trial focused on patients 
categorized into groups 2 to 4. This trial will focus on patients categorized into groups 3 and 4. In group 4, 
however, most patients are expected to have such comprehensive need for healthcare services that they are less 
likely to benefit from telehealth compared to patients in group 3. At the same time, some patients in this group 
can probably benefit greatly from telehealth because it provides better control of their own health situation and 
reduced risk of deterioration. 
Figure 2: National model for telehealth in Scotland 
Source: Scottish Centre for Telehealth & Telecare (2017, s. 20), modified in The Norwegian Directorate of Health (2017, s. 10) 
3.2 Exclusion criteria 
Patients who are not competent to consent are excluded from participating in the trial. This means that patients 
who participate in the trial must be able to make their own decisions and understand the consequences of their 

 
own choices. A person who is competent to consent can reason and evaluate alternatives, can express credible 
choices and understand the consequences of their own choices.  
Other exclusion criteria include: 
• 
Patients who are unable to handle the tablet and the measuring equipment to be used 
• 
Patients with substance abuse; this patient group is often unstable, and telehealth is likely more applicable 
for patients who are likely to use the tablet and any measuring devices regularly and as intended. 
3.3 The number of participants 
The Norwegian Directorate of Health has defined a target number of participants at a minimum of 600 patients. 
3.4 Recruitment of patients 
Anybody, including health and care personnel, the patients themselves and their relatives can suggest patients for 
participation in the trial. In most cases, health personnel recruit patients. Suggestions are made to the project 
administration, which consists of municipality employees.  
The Norwegian Directorate of Health has stressed that it is important that the participating municipalities focus on 
recruiting patients. All participating municipalities have written plans for recruitment that are regularly evaluated 
and updated. Among actions that are undertaken to promote recruitment of patients are information meeting at 
hospitals and GP offices, newspaper articles and the like. 
4.1 Telehealth 
Organization and responsibilities 
The Norwegian Directorate of Health has outlined guidelines on how to organize telehealth in clinical practice, yet 
the participating municipalities may adapt the service according to local needs (within the guidelines). The local 
centers are responsible for facilitating cooperation between the general practitioner scheme, the follow-up 
service and the municipalities’ other health and care services. The centers are also responsible for equipment, 
technological solutions and telehealth software. This includes the procurement, logistics, training in the use of 
equipment and user support. Four different suppliers of technological solutions are involved in the trial, and 
consequently, technological solutions may vary across the municipalities. In addition, the centers may differ in their 
target population (with respect to main diagnoses), main recruitment channels, and the design of the service itself. 
For example, the follow-up service may have different opening hours or different physical location (e.g. at the 
emergency room or at the home nursing care unit).  
Patient follow-up 
Once it has been decided that a patient will receive telehealth, the GP should, together with the patient, nurse 
and possibly other health personnel, prepare a follow-up plan based on the patient's goals, disease burden and 
risk of deterioration. The Norwegian Directorate of Health, in collaboration with the participating centers are 
currently developing standardized follow-up plans. 
Once the follow-up plan has been outlined, the user receives a tablet and potentially measuring instruments. The 
user is offered training in how to use the equipment. The tablet is used to answer simple questions about the 
patient’s own health and/or perform measurements related to health status (such as blood pressure, blood sugar, 
oxygen saturation, weight). The registered results are automatically transferred from the measuring devices to the 
tablet so that user can see them and track their own results over time. The results are also automatically 
transmitted digitally to the follow-up service, which contacts the user in case of abnormal results.  
Patients receiving telehealth will receive follow-up from a nurse1 at the follow-up service. The nurse monitors the 
user’s measurements and provide medical support and guidance based on the user’s needs. The nurse will respond 
                                                     
1 Centers involved in the pilot study with multidisciplinary care teams may engage the same nurses in follow-up of patients 
receiving care from both multidisciplinary care teams and telehealth follow-up. 
4. Treatment – telehealth vs. standard clinical care 

 
to abnormal results, and will, in consultation with the patient, consider whether the user should contact the GP or 
the emergency room.  
The health personnel will, in consultation with the user, determine how often the user should carry out the 
measurements. For most user’s, the frequency of the measurements will be gradually reduced over time. Different 
health conditions and diagnoses will require different follow-up; thus, the frequency of measurements will vary 
across users. The frequency of measurements will be recorded. 
The technological solutions will inform the patient and the follow-up center when the measurement results deviate 
from the normal values for the user. The threshold values for when measurements are considered abnormal are 
dynamic and defined in consultation between the health personnel and the user. The notifications are illustrated 
by red, yellow or green, and the employees in the follow-up service act based on previous measurements from 
the user, threshold values and / or the user's perception of their own health that day. If a user does not perform 
the scheduled measurements, this can also cause the follow-up service to contact the user. 
4.2 Standard clinical care 
Patients who are assigned to the control group will receive standard clinical care. Exactly what kind of care they 
will receive depends om their illness and their needs.  
Potential participants are first proposed by health personnel at hospitals or in municipal health and care services, 
by GPs, by patients themselves or their relatives, either directly to the patient's GP or to the project 
administration (possibly via the municipal allocation office2) (step 1 in Figure 3). Participation proposals are 
forwarded from the project administration to the GP. Then, the GP, who has the medical responsibility for the 
patients on their patient list (i.e., within the GP scheme), is responsible for deciding whether the patient is eligible 
for receiving telehealth (step 2). In cases where the GP receives proposals directly, the GP makes this assessment 
immediately. If a patient is considered eligible, the patient is invited to an information meeting with a project 
employee where the patient is offered the opportunity to participate in the trial (step 3). If the patient gives her 
consent to participate in the trial, the patient is randomized into an intervention or a control group (step 4). 
Randomization takes place in connection with the information meeting, and the project administration is 
responsible for the randomization. Thereafter, the patient receives further follow-up depending on which group 
they are allocated to (step 5). 
Figure 3: Recruitment in the randomized control trial of telehealth 
 
5.1 Step 1: Potential participants are proposed for the trial 
Both patients themselves, relatives, general practitioners and health care personnel at hospitals or in the municipal 
health and care service may propose relevant patients for the trial of telehealth. If the patient himself proposes to 
participate, the procedure will be adapted depending on where the patient first approaches his / her desire for 
participation (see below). Patients who are proposed as study participants will be informed that the trial of 
telehealth is carried out as a randomized-controlled trial. 
Recruitment via health personnel in hospitals or in municipal health and care services 
Health personnel (of any type) in the specialist health service or in the municipal health and care service may 
propose patients for the trial. Health personnel who recruit patients should be familiar with the inclusion criteria. 
The health personnel may conduct an informal, introductory conversation with relevant patients and inform about 
                                                     
2 By municipal allocation office, we mean the unit in the municipality that makes decisions about which municipal services are to 
be granted. 
5. Recruitment of study participants 

 
telehealth and the related trial (including the recruitment process and follow-up). The conversation will form the 
basis for an assessment of the patient's interest and motivation for participating in the trial, as well as the 
prerequisites for using simple technology. The patient must (orally) consent to being proposed for participation in 
the trial. Health personnel make an overall assessment of eligibility based on the conversation with the patient 
and, if deemed eligible, send a proposal for participation in the trial. The proposal is sent to the patient’s GP or 
the center’s administration (depending on how the local organization of the service). Such a notification constitutes 
an important part of the decision-making basis for the GP who decides whether the patient is suitable for 
participation in the trial. The message should be concise and contain information about the patient's state of 
health, suitability for telehealth, and motivation, as well as confirmation that the patient is informed about the 
trial. The centers prepare routines for how the message is transmitted from health personnel to the GP, to ensure 
the patient’s safety and privacy. 
Recruitment via the general practitioner 
GPs who participate in the trial assess which patients on their list can benefit from the use of telehealth, based on 
their own knowledge of the patients. In the face of patients who are suitable for telehealth, the GP can discuss the 
items as described above (in the section "Recruitment via health professionals in hospitals or in municipal health 
and care services") with the patient and then report the patient to the project administration. 
Self-recruitment or recruitment through relatives / acquaintances 
Patients and their relatives may suggest themselves as participants in the trial. This may occur if the patient for 
example hears about medical distance monitoring via acquaintances, reads about it in the newspaper or the like. 
These patients can contact the GP, the health personnel in the municipality or the specialist health service to get in 
touch with the project administration. 
5.2 Step 2: The GP assesses eligibility  
The Norwegian Directorate of Health has planned that approximately 100 GPs will participate in the trial. The 
centers have signed letters of intent with GPs who are committed to recruiting patients for the trial. The GP has 
the medical responsibility for the patients on their list and should therefore assess the patient’s eligibility for 
telehealth (i.e., whether the patient meets the inclusion criteria) based on their knowledge of the patient, patient 
records and the information in the proposal message from the project administration or other health personnel.  
Practitioners who are not informed about the trial 
Some patients, who are recruited from hospitals, home care services or others, may have a GP who is not involved 
in the trial (and thus did not sign a letter of intent). These GPs may not be familiar with the trial. In these cases, the 
project administration will inform the GPs about the trial. These GPs can recruit patients to the trial on the same 
basis as GPs who have been involved from the start of the trial. 
5.3 Step 3: Patients are invited to participate in the trial 
Patients who have been deemed eligible for participation by the GP will be contacted by the project 
administration and invited to an individual meeting where the patient is invited to participate in the trial. The 
information meeting can be held at the project employee's workplace, or at the patient's home if necessary due to 
the patient's health condition. At the information meeting, the project employee will inform the patient about the 
trial and about telehealth. The meeting will include: 
• 
Information about the trial and what participation means for the patient. The Norwegian Directorate of 
Health and the centers have prepared information material (a brochure and an information film) that can be 
used as a basis for the discussion. 
• 
Obtaining consent for participation (see details below) 
• 
Completion of a questionnaire about her physical and mental health, follow-up from and experiences with 
the health and care service, and background information, including demographics, marital status, place of 
residence and housing, scope of informal care from family and friends, use of other types of welfare 
technology (security alarm, self-help tools, etc.). 
• 
Randomization into intervention or control group (see section 5.4) 
• 
Information on further follow-up (see section 5.5) 

 
Obtaining consent for participation 
After the project employee has informed the patient about the trial and what the participation entails, the patient 
is asked whether he / she agrees to participate in the trial. If the patient agrees to participate in the trial, the 
patient signs the consent form. A requirement for participation is that the patient is competent for consent. 
Relatives cannot consent on behalf of the patient. The patient cannot receive telehealth without the consent to 
participate in the trial. 
If the patient does not agree to participate in the trial, the meeting ends, and the patient is followed up further 
by the healthcare service according to standard clinical care. In this case, the patient will not be able to receive 
telehealth, and patient information is not recorded as part of the trial. However, anonymous information is 
registered to inform the analysis of loss-to-follow-up (see section 9.5). If the patient does not agree to participate 
in the trial, the randomization envelope is not opened, and the project employee brings the unopened envelope 
back to the office and place it back in the stack of envelopes.  
If the patient needs more time before he / she decides whether to participate or not, the patient may have a 
reflection period of a maximum of two weeks. Equipment for the use of telehealth cannot be delivered to the 
patient before the patient has signed the consent statement for participation in research. 
5.4 Step 4: Consenting patients are randomized 
Patients who agree to participate in the trial sign the consent form before the randomization process. Once the 
patient has signed the consent form and completed the baseline questionnaire, the patient and the project 
employee open the randomization envelope together. The project employee informs the patient about the 
outcome of the randomization and explains how the follow-up will be organized (described in more detail in 
chapter 5.5). The meeting ends, and the project employee ensures that the patient is followed up in accordance 
with the protocol according to assigned treatment group (i.e., intervention / control). 
Participants in the control group may, after the end of the follow-up period, receive a new assessment of the use 
of telehealth. Participants who withdraw their consent will be able to receive a new assessment no earlier than 
one year after the consent is first signed. 
5.5 Step 5: Assessments of participants 
Assessments the intervention group 
How telehealth will be delivered will vary between both centers and individual patients. During the information 
meeting, the patients are informed of what is expected from them in connection with the evaluation of the trial 
(Table 2). Participants in the intervention group will be asked to complete a questionnaire every six months during 
the follow-up period, which lasts up to18 months. The first questionnaire is completed at the information meeting. 
The questionnaires are distributed by mail.  
Some users (and their relatives) will be requested to be interviewed one or two times during the project period. In 
addition to questionnaires and interviews, we collect information about the patients from various administrative 
registries, including the use of health and care services within municipal health and care services, the fixed-care 
service and the specialist health service. Details of the registry data are described in Table 3.   
Table 2: Assessments of participants in the trial 
 
Intervention group 
Control group 
Questionnaire  
• 
Survey every six months for 18 
months 
• 
The collection of survey information is 
terminated in June 2021 
• 
Survey every 6th month for 18 
months 
• 
The collection of survey information is 
terminated in June 2021 
Interviews 
• 
Selected participants are interviewed 
once or twice during the follow-up 
period 
• 
None 
Registry data 
• 
Registry data are collected for the 
period 2017-2022 
• 
Registry data are collected for the 
period 2017-2022 

 
Patient data from the 
follow-up service 
• 
Data on measurements are collected 
if the patient uses telehealth  
• 
The collection of information is 
terminated in June 2021 
• 
None 
 
Assessments in the control group 
Patients included in the control group receive regular follow-up from the health service. They are informed that 
they are expected to participate in the trial by completing a questionnaire every six months during the follow-up 
period, which lasts for up to 18 months or until the patient withdraws their consent for participation. The first 
questionnaire is filled out at the information meeting. The following questionnaire is distributed by mail. We will 
collect registry data for the participants in the control group (corresponding register data for the participants in 
the intervention group). After the follow-up period, participants in the control group may receive a new 
assessment related to telehealth. 
5.6 After the follow-up period 
After completing the 18-month follow-up period, the participants can have a new the assessment of eligibility for 
the use of telehealth if the municipality continues the service. If a patient in the intervention group still receives 
telehealth, we will continue to record information from the follow-up service unless the patient does not consent to 
this. We will collect this information until June 30, 2021. 
We will obtain registry data information covering all participants in the period 2017-2022. We collect data 
after the follow-up period to allow potential analyses of longer-term effects.  
5.7 Withdrawal from the intervention and/or the trial 
Patients may withdraw from receiving telehealth at any time during the study period, without reasoning, by 
contacting the local project administration. Study participants may withdraw from the trial with or without 
withdrawing their consent to participate. If a participant withdraws from the trial and withdraws the consent, 
collected information about the patient will be deleted and no additional information will be collected. If the 
patient withdraws without withdrawing their consent, collected information will be stored and used in the 
evaluation. The patient will be asked if he/she is willing to participate in the evaluation through questionnaires or 
interviews. The patient will also be asked if registry data can be collected until the end of the project period. 
The municipality is responsible for following up patients who are withdrawing from the trial. 
Trial discontinuation 
The randomized control trial may be discontinued in the event of any of the following 
• 
Occurrence of adverse events unknown to date with respect to their nature, severity and duration 
• 
Medical or ethical reasons affecting the continued performance of the trial 
• 
Difficulties in the recruitment of patients 
• 
Continued financing of the trial is not prioritized by the Parliament 
5.8 Exceptions from the study procedure: patients enrolled in the previous 
trial who wishes to continue receiving telehealth 
Patients who already receive telehealth within the previous trial of telehealth at the start of the new trial continue 
to receive telehealth and will not be included in the current trial. 
5.9 Linkage to other registers 
In addition to variables collected in the trial, patients are asked to give consent to collection of data from 
registries such as the Norwegian Prescription Database, The Norwegian Health Economics Administration and the 
Norwegian Patient Register. This allows certain outcomes to potentially be obtained through linkage to national 
medical or public registers and databases to answer research question related to health economics. 

 
6.1 Physical and mental health 
One of the three main goals of the effect evaluation is to investigate the effect of telehealth on the users' health 
status, including physical and mental health, and associated health-related quality of life.  
The study population consists of relatively old and ill patients with chronical illnesses. Previous experiences suggest 
that comorbidity is common in this group. The hypothesis is that the use of telehealth will improve the physical and 
mental health of the intervention group relative to the control group. Given the medical condition of the study 
population, a relative improvement in the physical health does not necessarily correspond to an absolute 
improvement. Rather, it is expected that the use of telehealth can lead to a stable development or a slower 
decline in physical health compared to the control group. 
Health-related quality of life (EQ-5D) 
We focus on self-reported health status using the validated questionnaire EuroQol 5 Dimensions 5 Levels (EQ-5D-
5L) which is used to measure health status and associated health-related quality of life. The form contains five 
dimensions of health, including walking, personal care, ability to perform common tasks, pain / discomfort and 
anxiety / depression. For each of these dimensions, the patients indicate a level of 1-5, which describes the 
degree of health problems within each dimension (no problems, some problems, moderate problems, severe 
problems, extreme problems). The response combination of level within each dimension allows a total of 3125 
different health conditions. Research-based methods have been developed to assign a quality of life value 
between zero and 1.0 to each of the 3125 combinations. 
We will measure patients’ EQ-5D scores during follow-up. Changes in EQ-5D scores for patients in the 
intervention group will be compared with changes in EQ-5D scores in the control group. Telehealth is considered 
to improve health-related quality of life if patients in the intervention group experience a statistically significant 
improvement (at a 95 % confidence level), or a lower deterioration, in health-related quality of life during 
follow-up compared with patients in the control group.   
Physical functioning (IPLOS functioning score) 
A relative improvement in physical functioning is measured as the difference in the IPLOS functioning score 
between the intervention and control group. 
Sleep quality 
Participants are asked "Hvis du tenker på de siste 7 dagene, i hvilken grad har du... A) Hatt problemer med å 
sove om natten B) Hatt problemer med å sove for mye?" (If you think about the last 7 days, to what extent 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". 
Coping with one’s disease 
Participants are asked several questions about their coping with their medical conditions and how they are 
managing their everyday lives. 
• 
I hvilken grad opplever du at du har kontroll over helsesituasjonen din? (To what extent do you feel that 
you have control over your health situation?) 
• 
I hvilken grad opplever du at helsetilstanden din gjør det vanskelig å planlegge hverdagen? (To what 
extent do you feel that your health condition makes it difficult to plan everyday life?) 
• 
I hvilken grad opplever du at du forstår din kropps signaler og symptomer? (To what extent do you feel 
that you understand your body's signals and symptoms?) 
• 
I hvilken grad opplever du at helsetilstanden din gjør det vanskelig å realisere dine evner og mål? (To 
what extent do you find that your health condition makes it difficult to realize your abilities and goals?) 
Answers on a four-point scale ranging from "Not at all" to "To a very large extent". 
6. Assessments 

 
Qualitative assessments 
The quantitative assessments described above are supplemented with insights from interviews on the themes listed 
above. Interviews are conducted with a sample of patients, relatives, and GPs and other health personnel. An 
overview of the interviews to be conducted is found in Table 5. 
6.2 Patient experience 
Overall satisfaction with treatment and follow-up  
Patients are asked "I hvilken grad er du fornøyd med oppfølgingen av din helse?" (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" 
Satisfaction with involvement of the GP 
Patients are asked "I hvilken grad opplever du at din fastlege er tilstrekkelig involvert i oppfølgingen av din 
helse?" (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 ranging from "Not at all" to "To a very large extent". 
User involvement 
Patients are asked "I hvilken grad opplever du at du har mulighet til å medvirke til din egen behandling?" (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" 
Qualitative assessments 
The quantitative assessments described above are supplemented with insights from interviews on the themes listed 
above. Interviews are conducted with a sample of patients, relatives, and GPs and other health personnel. An 
overview of the interviews to be conducted is found in Table 5. 
6.3 Use of health and care services 
The use of health and care services is analyzed using information from various national registers. Health and care 
services include all kinds of services from primary and specialist health care providers. The use of health and care 
services is registered for all participants in the period 2017-2022. Thus, the use of health and care services can 
be followed at least two years before and up to three years after recruitment. 
Use and costs are calculated on a yearly basis from recruitment. 
The following outcomes are analyzed: 
• 
The number of consultations with the GP 
• 
Contact with the follow-up service 
• 
Number of visits to the home service 
• 
Scope and composition of home-based care services 
• 
Number and scope of municipal emergency unit (KAD) stays 
• 
Number of contacts with emergency services 
• 
Number and composition of outpatient consultations and day treatments 
• 
Number, scope and composition of hospital admissions and bedtime 
• 
Number of emergency admissions due to complication of chronic disease 
• 
Number and composition of consultations with private specialists 
• 
Scope and composition of drug use 
Total health and care cost per person 
Total costs for health and care services per person are calculated on a yearly basis using publicly available 
statistics of cost related to the use of health and care services and actual use of health and care services. Total 
costs are also split between different parts of the health service (primary and specialist health care services).  

 
6.4 Process evaluation 
We will evaluate the process, that is, examine how the service is developed and implemented within the local 
context. In this exploratory analysis, we will mainly rely on in-depth interviews with key actors in the different 
health care contexts, supplemented with survey data. Examples of topics are: 
• 
Organization of the service in the municipality 
• 
Involvement of other health care providers: the GP, home nursing, specialist health care 
• 
Extent of follow-up 
• 
Technological solutions 
• 
Involvement of users and their relatives 
• 
Patient’s own treatment plan 
• 
Inclusion and exclusion criteria 
• 
Financing of the service 
• 
Telehealth in municipalities with primary health care teams 
The process evaluation will rely om insight from interviews.  
6.5 Cost-benefit analysis 
In Norway, cost-benefit analyses are used to inform decision making and prioritization across all sectors of the 
economy. The purpose of this cost-benefit analysis is to assess the overall benefits and costs of the use of 
telehealth. This analysis will also elucidate distributional effects and an assess the societal value of telehealth 
(including an assessment of which factors are essential in ensuring the value of telehealth). 
The analysis will use data obtained in the effectiveness study and in the process evaluation, supplemented with 
separate collection of national statistics, interviews with key stakeholders and findings in the research literature. 
The analyses are carried out in accordance with the steps in the guide for socioeconomic analyses from the 
Directorate for Financial Management (Direktoratet for økonomistyring, 2018) and the specific guidelines for 
analyses from the Norwegian Directorate of Health (Helsedirektoratet, 2012). In accordance with the framework, 
the analysis includes all types of effects, both monetized and non-monetized effects, as well as intended and 
unintended effects.  
According to the current guidelines for conducting cost-benefit analyses in Norway (Direktoratet for 
økonomistyring, 2018), the consequences of telehealth will be measured against the zero alternative, which in this 
case involved standard clinical care.  
Other pilot projects that may be partly overlapping with this study (for example, multidisciplinary care teams 
within primary care (Helsedirektoratet, 2018) and structured interdisciplinary follow-up teams (Helsedirektoratet, 
2018)) have also been implemented in this same period. We will assess whether the various interventions 
"cannibalize" or "accelerate" the beneficial effects when interacting (decreasing vs. increasing marginal benefit). 
We will assess the societal value based on the monetized effects, and then consider to what extent non-monetized 
effects contribute to the societal value. After an assessment of key uncertainties and distributional effects, the 
value of introducing telehealth can be compared with standard clinical care. The analysis of distributional effects 
will shed light on how benefits and costs are distributed between primary and specialist health services, as well as 
in the general population and for general practitioners, municipalities and health enterprises. 
The local centers are responsible for the detection and documentation of adverse events. 
7. Safety monitoring and reporting 
8. Data Management and monitoring 

 
8.1 Case report forms (eCRF) 
Staff at the local centers enter the data required by the protocol into the electronic Case report forms (eCRF) and 
are responsible for assuring that data entered the eCRF is complete, accurate, and that entry is performed in a 
timely manner. If any assessments are omitted, the reason for such omissions should be noted in the eCRFs. 
Corrections and the reason for these will also be recorded. 
The case report forms are developed in Microsoft Excel.  
8.2 Source data 
The following data are recorded directly into the eCRF by the project administration: 
• 
Health-related information: diagnoses (main diagnosis, other diagnoses) use of other types of welfare 
technology (safety alarm, self-help tools, etc.) 
• 
Information related to recruitment to the trial: consent, intervention / control group, recruitment channel, 
important dates (first inquiry, information meeting, signed consent, start-up, termination), equipment 
provided, cause of any interruption 
• 
In addition, simple anonymous registration of gender, age (in categories), and recruitment channel 
(hospital, municipal health and care service, GP, self-recruitment), main diagnosis, as well as the reason 
for the drop-out of those who are invited to participate but who do not want to participate. 
8.2.1 Data from national administrative health registers 
Data will be used at the individual level from various health registers and administrative registers, and these will 
be linked at the individual level. Data will also, after consent, be linked to information from surveys and from the 
follow-up service. Register data is obtained for all participants in the trial in the period 2017-2022.  
An overview of the different registries and variables is provided in Table 3. 
Table 3: National administrative health registers 
Data source 
Type of variables 
The Norwegian Health Economics Administration 
Database (KUHR) 
Use of GP and emergency room services. 
General practitioner register (Fastlegeregisteret) 
Information about patient’s GP 
Municipal patient and user register (KPR) 
Use of municipality health and care services 
Norwegian Patient Register (NPR) 
 
Use of somatic and psychiatric hospital services (in-
patient and out-patient) 
Norwegian Prescription Database (Reseptregisteret) 
 
Use of pharmaceuticals 
The participating municipalities' EHR systems 
Use of municipality health and care services 
Municipality-State-Reporting (KOSTRA) 
Resource use at municipal level 
 
8.2.2 Data from surveys 
As part of the evaluation, we will carry out three different surveys: to users, to general practitioners and to 
employees in the follow-up service. The surveys are used to obtain both quantitative and qualitative data. 
Quantitative data is obtained in areas where register data does not extend, e.g. in areas such as health status, 
quality of life, patient experience, as well as time spent and quantitative assessments of telehealth. The 

 
questionnaires are also used to obtain information of a more qualitative nature, typically in the form of open 
questions about i.e., patient experience, or health personnel's assessments of recruitment, organization, benefits 
and challenges. The surveys are a useful supplement to interviews as they reach a larger number of respondents, 
thus providing more breadth than a limited range of interviews. Insights from the surveys can often be followed up 
in interviews and in this way the various data sources complement each other. An overview of the surveys is 
presented in Table 4.  
Table 4: Overview of surveys 
Recipients 
Time 
Distribution 
Number of 
recipients 
Themes 
Control 
Questionnaire 
Participants 
(intervention 
and control 
group) 
At recruitment, 
and thereafter 
every six 
months. Max. 4 
times. 
Postal 
600 
Health related quality of 
life (EQ-5D), valuation of 
own health, sleep quality, 
physical activities, mental 
health, coping, user 
experience in the health 
and care service, 
demographics 
Randomized 
control group 
Appendix B – 
Participant 
questionnaire 
General 
practitioners 
Fall 2019, 
Spring 2021 
Electronic 
All who have 
patients in the 
trial 
Recruitment, inclusion and 
exclusion criteria, follow-
up of participants, 
cooperation with other 
health and care providers, 
experiences with 
telehealth 
None 
Appendix C – 
GP 
questionnaire 
Follow-up 
service 
Fall 2019, 
Spring 2021 
Electronic 
All employees 
in the follow-
up service 
Recruitment, inclusion and 
exclusion criteria, follow-
up of participants, 
cooperation with other 
health and care providers, 
experiences with 
telehealth, time-use 
None 
Appendix D – 
Follow-up 
service 
questionnaire 
8.2.3 Interviews 
During the project period, interviews will be conducted with several different stakeholders: patients, relatives, 
GPs, employees in the follow-up service, the local center administration, municipal administration, employees in 
the municipal health and care services and the specialist health service. 
There are two purposes of the interviews:  
1. Provide input for the process evaluation by shedding light on issues, such as recruitment, participation 
and organization of the telehealth service. The target group is typically users and relatives, as well as 
employees in the health service with close association with the trial.  
2. The second purpose of the interviews is to obtain information for the cost-benefit analysis. For this 
purpose, we also interview persons with managerial responsibility in municipal administration, municipal 
health and care services, and in the specialist health service. 
An overview of planned interviews is shown in Table 5.  
Table 5: Overview of interviews 
Target group 
Time 
No. of 
respondents 
Themes 
Type of interview 
Users of telehealth 
solutions 
2019, 2021  2-5 per 
center 
Patient experience, safety, coping, 
health status, recruitment 
Individual  

 
Participant in the control 
group 
2019, 2021 
1-2 per 
center 
Patient experience, safety, coping, 
health status, experiences in the 
control group 
Individual 
Relatives  
2019, 2021 
2-3 per 
center 
Experience with telehealth, time-use, 
coping, security, shift of responsibility 
and work tasks 
Group (together 
with user of 
telehealth)  
General practitioners 
2019, 2021 
2-3 per 
center 
The local and national context, 
Recruitment, inclusion- and exclusion 
criteria, follow-up of telehealth 
patients, collaboration with other 
health care providers, costs and 
benefits (for patient, doctor, society), 
follow-up of patients in the control 
group. 
Individual 
Employees in the follow-
up service 
2019, 2021 
At least one 
per center, 
preferably 
all 
Success criteria for good medical 
follow-up, how to succeed in 
practice, costs and benefits (for 
patient and society), organization of 
follow-up service, collaboration  
Group 
Local center 
administration 
2018, 2019, 
2020, 2021 
All  
Collaboration with other health care 
providers, organization, national 
context, costs and benefits (patient, 
health and care services and 
society), challenges, shifting of tasks 
and responsibilities, follow-up of 
patients in the control group 
Group 
Representatives from the 
municipality health and 
care services 
2019, 2021 
1-5 per 
center 
Local and national context, 
recruitment (inclusion / exclusion 
criteria), collaboration and 
interaction, costs and benefits 
(patient, health and care services 
and society), challenges, shifting of 
tasks and responsibilities 
Group 
Representatives from the 
specialist health care 
services 
2019, 2021 
1-5 per 
center 
Local and national context, 
recruitment (inclusion / exclusion 
criteria), collaboration and 
interaction, costs and benefits 
(patient, health and care services 
and society), challenges, shifting of 
tasks and responsibilities 
Group 
 
8.2.4 Data from the follow-up service 
The researchers are investigating the possibilities of obtaining data from the follow-up service. Two types of data 
are required from the follow-up service: 
• 
Patient registrations (answers to questions related to patients physical and mental health and 
measurements transferred to the follow-up service via the tablet) 
• 
Contacts with the follow-up service 

 
Patient measurements 
As part of the medical distance follow-up, users answer simple questions about their own health and day-care. 
Some carry out simple measurements, i.e. weight, temperature, blood pressure or oxygen measurement. This data 
is sent to and registered with the follow-up service. By linking data from the follow-up service to other health 
registers, we will be able to form a more comprehensive picture of the patients' health status and their 
development. Tabell 6 gives an overview of the most important types of data. These data are naturally only 
available for patients in the intervention group. 
Tabell 6: Overview of patient registrations (non-comprehensive) 
Type of data 
Outcome measure 
Questions related to 
physical and mental 
health 
• 
Assessment of current health status 
• 
Breathing 
• 
Mood  
Measurements 
• 
Blood glucose 
• 
Long-term blood sugar (HbA1c) 
• 
Blood Pressure 
• 
Weight 
• 
Temperature 
• 
Oxygen measurement / spirometry? 
• 
Pulse 
 
Contacts with the follow-up service 
If possible, we would like to have access to aggregated data on inquiries to the follow-up service at project and 
monthly level. Information on the use of the follow-up service will constitute an important part of the data basis for 
the socio-economic analysis. 
It will be relevant to analyze the following types of information: number of users (new, active, completed), number 
of users with additional need for training, number of measurements, number of contacts (electronic and telephone), 
number of deviations on equipment, number of maintenance tasks, number of contacts with GP and other health 
personnel, courses for employees, etc. Exactly what information can be delivered depends on the service 
provider. This type of information will not be linked to individual users. 
8.3 Study monitoring 
The researchers will on a regular basis check the following: 
• 
Informed consent process 
• 
Reporting of adverse events and other safety data 
• 
Adherence to protocol 
• 
Maintenance of required regulatory documents 
• 
Data completion of the CRFs 
8.4 Confidentiality 
The municipalities are responsible for the secure retention of the patient identification and the code list. The eCRFs 
are linked with other source data by the Norwegian Prescription Database, who will replace the social security 
number with an anonymous personal identifier. The linked data material is delivered to the researchers without 
the social security number, but with the anonymous personal identifier. 
8.5 Database management 
A data management plan will be developed describing the quality control of the CRF, data entering procedures, 
coding and security. Patient files shall be kept for the maximum period permitted by each municipality. The study 
documentation shall be retained and stored during the study and two years after study closure. All information 
concerning the study will be kept in a safe place inaccessible to unauthorized personnel. 

 
8.6 Collection and storage of data 
Different types of source data will be collected in the study, and strict data retention requirements are set. It will 
include data processing agreements between the researchers and all participating municipalities, as well as with 
the suppliers of the technological solutions if they supply data to the project, and other third parties involved in 
the study. 
Services for Sensitive Data (TSD) at the University of Oslo will be responsible for storing linked data in the 
project. Only authorized project members will have access to data from this server. 
The register data is collected up to and including 31.12.2022. Then, data is stored for up to two years before 
they are deleted (31.12.2024). 
The research consortium is together responsible for all data collected in the study. However, main responsibility 
for the different sources are distributed as follows: 
• 
University of Oslo has the main responsibility for the collection and storage of the registry data 
• 
Oslo Economics has the main responsibility for the collection and storage of the survey and interview 
data 
9.1 Determination of sample size 
The Norwegian Directorate of Health decided that 600 participants should be included in the trial, and the 
participating centers have committed to recruit patients according to this goal. This should not be regarded as a 
ceiling for how many patients can be recruited, and the centers have stated that they hope to recruit a larger 
number of participants. The sample size was decided by the Norwegian Directorate of Health prior to 
involvement from the research consortium, and power calculations were not used to calculate how many patients 
should be included in the trial. 
The power calculations in Table 7, are based on the results of the previous trial of telehealth that was carried out 
by the NDH in 2016-2018 (Intro International, 2018). The trial investigated of the same endpoints, for a similar 
population. However, in the previous trial there was a greater spread in the degree of morbidity, but somewhat 
less spread in terms of diagnosis compared with the trial that is now being carried out. The number of users was 
also lower in the previous trial than we expected in this trial. Thus, there is some uncertainty associated with the 
reported standard deviations, and followingly, the calculations may overestimate the required sample size. 
In Table 7, we focus on four outcome measures: self-assessed health status (VAS) from the EQ-5D questionnaire, 
number of regular GP consultations, number of outpatient consultations and number of bed-days in hospitals..  
From the previous trial, we know that after 5 to 9 months of telehealth follow-up, users reported self-rated health 
state at 0.612 (on a scale of 0 to 1), and this decreased by an average of 0.105 units from start-up. Thus, the 
users of medical distance monitoring experienced a decrease in self-assessed health status, but our hypothesis is 
that a control group would experience an even greater decline. In panel A, we show the required sample size to 
identify a statistically significant effect at a 5 % level with strength of 80 % for three different outcomes: that the 
action group reports 0.05, 0.08 or 0.105 lower reduction in self-assessed health status during the follow-up 
period compared to with the control group. In panel B, the desired sample size is calculated based on the number 
of GP consultations per year. In the previous trial, the participants experienced an average reduction of 2 visits 
per year compared to an average of 14.66 regular visits per year. We assume that the control group will be 
able to experience unchanged or increased number of GP consultations, and therefore calculate strength based 
on scenarios with a difference of 2-4 doctor visits. In panels C and D, the same calculations are repeated for the 
number of outpatient consultations and emergency days. The same reasoning applies. 
Our assessment is that a sample size of 600 is enough to estimate significant effects of telehealth, but that a 
larger sample is preferable. The NDH and the participating municipalities are informed about this and work to 
increase the number of participants. 
9. Statistical method and data analysis 

 
Table 7: Power calculations 
Mean, 
intervention (st. 
dev.) 
Difference 
from control 
N intervention N control 
N total 
0,050 
356 
356 
712 
A. Visual analog scale (VAS) 
0,612 (0,238) 0,080 
139 
139 
278 
0,105 
87 
87 
174 
-2 
908 
908 
1816 
B. No. of consultation with GP  
14,66 (15,21) -3 
404 
404 
808 
-4 
227 
227 
454 
-0,5 
1081 
1081 
2162 
C. No. of outpatient consultations 2,34 (4,15) 
-1 
270 
270 
540 
-1,50 
120 
120 
240 
-1,33 
1371 
1371 
2742 
D. No. of emergency inpatient 
days 
4,14 (12,43) 
-2,00 
606 
606 
1212 
-2,50 
388 
388 
776 
 
9.2 Randomization 
Patients who agree to participate in the trial are randomized 1: 1 to the intervention and control group. The 
treatment allocation is non-blinded in that both providers and patients will know the outcome of the treatment 
allocation. The actual randomization is carried out by a project employee in the local centers. The project 
administration stores sealed randomization envelopes in their office.3 Each sealed envelope contains a sheet 
marked with either "tiltak" (intervention) or "kontroll" (control), which determines which group the patient is placed 
in. For each GP in the trial, there is a separate stack of six envelopes: three " intervention " and three "control". 
Each time a patient on GP's X's list is invited to an information meeting, the project employee takes the top 
envelope from GP's stack of envelopes. If more than six patients are recruited on the GP's patient list, the project 
employee will receive a new stack of six envelopes for this GP. Thus, we can ensure that there will be 
approximately equal distribution of intervention and control patients from each GP. Oslo Economics distributes the 
stacks of opaque envelopes to the projects. 
If a patient is invited to an information meeting and the patient's GP has not previously been involved in the trial, 
a separate stack of envelopes for this GP should be obtained prior to the meeting so that the patient can be 
randomized into the trial. 
For each information meeting (chapter 8.3), the project employee takes an envelope from the appropriate GP's 
stack without opening it. The envelope is opened together with the patient after the consent form is signed, and the 
questionnaire is filled out. If the patient does not agree to participate in the trial, the envelope remains sealed. 
The project employee brings the sealed envelope back to the office and puts it back in the proper stack of 
envelopes. 
                                                     
3 This randomization technique was considered the best practically implementable technique given the practical 
implementation of the study.  

 
9.3 Sample for analysis 
We will study the following range of patients: 
• 
Intention to treat (ITT) population: this is the sample of randomized patients, regardless of whether they 
are followed up using telehealth or not 
• 
Per-protocol (PP) population: this is the sub-sample of the ITT population that follows the study protocol 
during the entire follow-up period (12-18 months) 
• 
Safety population: this is the subset of the ITT population that begins follow-up (uses telehealth), and 
either completes follow-up or withdraws from the study. 
The analysis will mainly be carried out using the ITT population. The reason for this is that loss-to-follow-up is likely 
to bias the results so that we estimate a greater effect of the use of telehealth than what is estimated by focusing 
on the PP population. Thus, an analysis of the ITT population is a more conservative estimate. 
In addition, we will carry out analyses where we compare the outcome of the intervention group with one or more 
registry-based control groups. The control groups can be selected based on discretionary assessments and / or by 
means of statistical methods, e.g. propensity score matching. It will be possible to base the choice of control group 
on variables such as gender, age, diagnosis and municipality of residence. The results of such an analysis will have 
to be interpreted with caution but will constitute an interesting supplement to the rest of the analysis. 
9.4 Statistical analysis 
The aim of the trial is to estimate the effects of telehealth on the three outcomes of health status, patient 
experience and resource use in the health service. The choice of statistical method for analyzing the data will be 
adapted to the characteristics of the outcome variables in question. 
Non-parametric methods 
For several variables, both from registers and from the surveys, we will use non-parametric tests such as Wilcoxon 
signed ranks test or McNemar test. In these tests, each of the collected variables is examined separately, and the 
null hypothesis is that there is no difference between the intervention and control group. This null hypothesis could 
be rejected if the individual test's test observer is above critical limit. We will use the conventional significance 
level of 5% in the statistical analyses. For the analyses of variables where we utilize the randomization of 
intervention and control group, statistically significant differences between the groups could have interpretation as 
causal effects. 
For parts of the data material, information will only be available for the participants in the intervention group. 
This applies to information that is directly related to receiving telehealth. In these cases, we will investigate 
whether there are changes in outcomes over time. The choice of statistical method could be the same as for other 
analyses. Significant changes will usually be interpreted as significant associations, but care will be taken to 
interpret any findings as causal effects. 
Parametric methods 
For some (groups of) variables, it will be relevant to use different types of regression models to study the effect 
of telehealth. Both difference-in-difference models and structural equation models will be applied. The use of 
structural equation models allows to study how telehealth affects a group of variables simultaneously. For 
example, it will be examined whether telehealth affects a group of health variables, a group of user satisfaction 
variables, or a group of resource use variables simultaneously. Where necessary, we will use structural equation 
models that consider that the outcome variables are binary / categorical and that the data material has so-called 
multi-level structure, since the material consists of repeated observations of the same individuals within the same 
municipality, over time. 
Explanation variables and sensitivity analysis 
There is considerable variation in the study. This applies to both the variation in the study population and the 
organization of the service. Sensitivity analyses will be carried out through inclusion of control variables and 
subsample analyses, but the extent of such analyses is limited by the relatively small sample size.  

 
9.5 Analysis of loss-to-follow-up 
We expect loss-to-follow-up among the participants in the ITT population, and it is important to document this in 
order to be able to interpret the results. Patients can drop out either before or after consent is given.  
We will register anonymous information about patients who drop out before consent is given. This includes 
gender, age (in intervals), main diagnosis, recruitment channel, reason for non-participation. 
Drop-out that occur after the consent has been obtained will be analyzed to ensure that drop-out does not drive 
the results. Characteristics of those who drop out will be compared to those who complete the follow-up. 
Drop out will also be highlighted through interviews with GPs and other health personnel, as well as with the 
project administration.  
10.1 The Norwegian Directorate of Health 
The Norwegian Directorate of Health is responsible for the practical implementation of the trial, and will: 
• 
Define the scope of the trial 
• 
Recruit participating municipalities 
• 
Assist the participating municipalities in designing and setting up the service 
• 
Follow the implementation of the project (incl. recruitment targets) 
• 
Partially finance the local projects  
• 
Establish a reference group for the trial 
10.2 The researchers 
The University of Oslo, Oslo Economics and the Norwegian Centre for Rural Medicine (NCRM) have joint 
responsibility for developing and implementing the study design. The University of Oslo and Oslo Economics have 
joint responsibility for data processing. The University of Oslo, Oslo Economics and the Norwegian Centre for 
Rural Medicine (NCRM) will: 
• 
Develop the research design  
• 
Apply for necessary approval from ethical committees and data protection services  
• 
Draw up data processor agreements with participating municipalities and third parties involved in the 
study 
• 
Conduct the evaluation as described in this study protocol 
• 
Present results in three reports 
10.3 The participating municipalities 
• 
Develop the service 
• 
Implement and run the service according to protocol 
• 
Recruit participants 
• 
Conduct study initiation meetings 
• 
Facilitate data collection 
10.4 Study amendments 
If it is necessary for the study protocol to be amended, the amendment and/or the new version of the study 
protocol must be notified to and approved by the management at the University of Oslo and Oslo Economics and 
the Norwegian Centre for Research data (NSD) according to EU and national regulations. 
10. Study management 

 
10.5 Audit and inspections 
Authorized representatives of the Data Protection Authority may visit the centers to perform inspections. Likewise, 
representatives from the Norwegian Directorate of Health may visit the municipalities to perform audits. The 
purpose of an inspection is to systematically and independently examine study-related activities and documents to 
determine whether these activities were conducted, and data were recorded, analyzed and accurately reported 
according to the protocol, and any applicable regulatory requirements. 
11. Risk assessment 
There are several risks connected with the telehealth trial. Risks are closely monitored by the NDH and the 
researchers. The following are among the most central risks identified: 
Recruitment of participants 
There is a worry that the recruitment target will not be reached within June 30, 2020. However, the NDH and the 
local centers have detailed plans for recruitment and follow the development closely. At the same time, the 
centers have signalized that they aim at recruiting more patients than they originally signaled. 
In December 2019, the NDH will evaluate the recruitment process. If recruitment is insufficient, one option is to 
terminate the trial.  
Spillover of treatment to control group 
A drawback of the randomization strategy is that there is a risk that the intervention spills over to the control 
group. The knowledge of the intervention might affect both the type and extent of the care that the control group 
receives. The health and care personnel are made aware of this issue. The patients in the study have a need for 
health care services, and the protocol is that they receive “standard clinical care”. In practice, what this means, 
depends om the patient’s medical condition and needs. 
It is important for the interpretation of the results of the study, that the actual treatment that the control group 
receives is studied. This is done in many ways. First, we collect information on the use of health and care services 
for the intervention and control group from national health registers. Second, we will interview health and care 
personnel about the follow-up of patients in the control group. Third, we will conduct interviews with patients in the 
control group about their experiences. Fourth, we plan to compare the outcomes of the treatment and the control 
group in the study to a register-based control group containing patients with similar characteristics in non-
participating municipalities. Thus, we will have an additional control group that is not affected by the trial. This 
comparison is performed using data from the related evaluation of primary health teams. 
If the patients in the control group receive more comprehensive follow-up than they would in the absence of the 
reform, the effects of the intervention are likely underestimated, rather than overestimated. 
Heterogeneity in the trial 
This telehealth trial is less rigorously designed that many conventional randomized control trials. There is variation 
in the delivery of the intervention (telehealth), in the follow-up of the control group, and in the study population. 
This poses some challenges in the analysis of the data, and effects must be interpreted as averages over different 
types of interventions and groups of patients. 
Data management 
The data management of the study is challenging. Data are collected and linked from several sources, at several 
point in time. This requires good procedures for data collection and management. A data management plan har 
been developed. 
12. Ethical and regulatory requirements  
12.1 Privacy Policy 
It is the joint responsibility of the University of Oslo and Oslo Economics to conduct a Data Protection Impact 
Assessment (DPIA). A DPIA was conducted together with the Norwegian Centre for Research data (NSD) in 

 
January 2019. The DPIA concludes that the data collection and storage within the project is conducted in 
accordance with the GDPR. 
12.2 Informed consent procedure 
The research group and/or the project administration is responsible for giving the patients full and adequate 
verbal and written information about the nature, purpose, risk and benefits of the trial. They are informed about 
the strict confidentiality of their patient data, but that their medical records may be reviewed by the researchers 
for evaluation purposes. 
It is emphasized that the participation is voluntary and that the patient can refuse further participation in the trial 
whenever she/he wants. This will not prejudice the patient’s subsequent care. Participants who withdraw their 
consent may request that all information collected be deleted, unless they are included in publications or articles.  
Patients who have not signed the written consent form cannot obtain equipment from the municipality, and consent 
is thus a prerequisite for participation in the trial. The consent form is enclosed in Appendix A. 
A copy of the signed consent statement is given to the patient. Signed consent statements are collected in a 
suitable folder by the project administration and will also be scanned and stored electronically at the project 
administration. 
Written consent will be also obtained from participants in the evaluation other than those in the intervention and 
control group. This includes interviewees, such as GPs, employees and the follow-up service, other representatives 
from the health and care service and relatives.  
12.3 Patient Identification 
The project administration keeps a record of everyone who has signed consent. This overview includes name, date 
of birth, and birth number and address. The personal information is stored in a separate password-protected 
document. 
Each participant gets a unique serial number that acts as a link between different data sources. The researchers 
will not have access to directly identifiable information about the patients. 
12.4 Confidentiality 
Healthcare professionals participating in the trial have a duty of confidentiality towards the patients. In interviews 
with health personnel, there will be no questions about individual patients. 
12.5 Ethical committee approval 
The Regional committees for medical and health research ethics (REK) has assessed the study protocol. In the 
decision from 26.11.2018, REK stated that the trial falls outside REK's area of responsibility as it was deemed as 
health services research and not medical research. 
12.6 Other regulatory approvals 
The protocol will be registered in www.clinicaltrials.gov in summer 2019. 
The trial is financed by the Norwegian Directorate of Health and the participating municipalities. The evaluation 
of the trial is fully financed by the Norwegian Directorate of Health. 
The results of the trial will be published in two midterm reports and a final report which will be submitted to the 
Norwegian Directorate of Health (see chapter 15).  
13. Trial sponsorship and financing 
14. Publication Policy 

 
We will also consider submitting the results for publication in international peer-reviewed journals. 
The participating municipalities were recruited in the spring of 2018. The summer and autumn of 2018 were 
devoted to service development and evaluation design. Recruitment of users and evaluation of the measure 
started in February 2019. The follow up period ends in the summer of 2021. The exact end date depends on the 
contract between the Directorate of Health and the individual municipalities. 
Table 8 shows important milestones in the evaluation, and Table 9 contains an overview of the progress of the 
evaluation. 
Table 8: Important milestones 
Milestone 
Date 
Recruitment starts 
01.02.2019 
First midterm report 
01.03.2020 
Second midterm report 
01.03.2021 
Recruitment ends 
30.06.2020 
Final report 
01.11.2021 
Last survey is posted 
30.06.2021 
Final report to the NDH 
01.12.2021 
Register data collection terminated 31.12.2022 
Project ends 
31.12.2022 
Data is deleted 
31.12.2024 
 
Table 9: Overall progress plan 
2018 
2019 
2020 
2021 
Quarter 
2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 
Planning and designing the evaluation 
  
  
  
Surveys 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Develop surveys 
  
  
  
Distribute and administer surveys 
  
  
  
  
  
  
  
  
  
  
  
  
Analysis of survey data 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Interviews 
Conduct 
  
  
 
  
  
  
  
  
  
Analysis 
  
  
  
  
  
  
  
  
Register data 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Collection of register data 
  
  
  
  
  
  
  
Analysis of register data 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Cost-benefit analysis 
Collect data 
  
  
  
  
  
  
  
  
  
  
  
  
Analysis 
  
  
  
  
  
  
Reporting 
  
  
  
Reporting 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Analysis 
  
  
  
  
  
  
  
  
  
Writing reports 
  
  
  
  
  
  
  
  
Seminars and presentations 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
15. Overall progress plan 

 
Project administration 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Project meetings 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Meetings with sponsor and stake holders 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Project administration n.e.c. 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
Direktoratet for økonomistyring. (2018). Veileder i samfunnsøkonomisk analyser.  
Helse- og omsorgsdepartementet. (2015). Omsorg 2020.  
Helsedirektoratet. (2012). Økonomisk evaluering av helsetiltak – en veileder.  
Helsedirektoratet. (2017). Videre innretning av medisinsk avstandsoppfølging - Rapport til Helse- og 
omsorgsdepartementet. Oslo: Helsedirektoratet. 
Helsedirektoratet. (2018). Ny utprøving av medisinsk avstandsoppfølging av kronisk syke: Rammer for forsøket. 
Oslo: Helsedirektoratet. 
Helsedirektoratet. (2018). Pilot for strukturert tverrfaglig oppfølgingsteam. Hentet June 24, 2019 fra 
Helsedirektoratet: https://www.helsedirektoratet.no/om-oss/forsoksordninger-og-prosjekter/pilot-for-
strukturert-tverrfaglig-oppfolgingsteam 
Helsedirektoratet. (2018). Primærhelseteam – pilotprosjekt. Hentet June 24, 2019 fra Helsedirektoratet: 
https://helsedirektoratet.no/primerhelseteam-pilotprosjekt 
Intro International. (2018). Avstandsoppfølging - Sluttrapport.  
Meld. St. 26. (2014–2015). Fremtidens primærhelsetjeneste – nærhet og helhet. Helse- og omsorgsdepartementet. 
Scottish Centre for Telehealth & Telecare. (2017). A National Service Model for Home and Mobile Health 
Monitoring.  
 
 
 
References 

 
 
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. 
 
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. 
 
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 
Appendix A: Participant consent form 

 
use the results of the research as the basis for national recommendations on distance follow-
up. 
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 (so-
called '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. 
 
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. 
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. 
Approval of the test 
We process information about you based on your consent. 
On behalf of the Department of Health and Society at UiO and Oslo Economics, NSD - 
Norwegian Center for Research Data AS has considered that the processing of personal data 
in this project complies with the privacy regulations. 
Voluntary participation and opportunity to consent 

 
Participation in the trial is voluntary. If you wish to participate, sign the Declaration of 
Consent at the bottom of this page. You may withdraw your consent at any time and without 
giving any reason and may require that information collected about you be deleted. This will 
not have any impact on your continued use of the public health services. If you later want to 
retire or have questions about the project, you can contact: 
Susanna Sten-Gahmberg, project manager at Oslo Economics, on mobile: 
451 34 135, or by e-mail: ssg@osloeconomics.no. Alternatively, you can contact the Privacy 
Ombudsman at UiO by email: personvernombud@uio.no. 
 
With best regards, 
 
Tor Iversen 
Project Manager 
Professor at UiO 
 
 
 
Consent Statement 
I have received and understood information about the project Proof of medical distance 
follow-up and have been given the opportunity to ask questions. I agree to: 
 
 Obtaining register information about me as described above (compulsory for 
participation in the trial) 
 To participate in a survey (compulsory for participation in the test) 
 To participate in an interview 
 That my personal data is stored after the end of the project for research purposes 
 That my relatives can be interviewed about my participation in the trial 
 
I agree that my information will be processed until the project is completed and will be 
deleted by 31 December 2027. 
 
 
 
 
(Signed by participant, date) 
 
 
 
 
 

 
Table 10: Overview of information obtained from local and national registers 
Type of information 
Variables 
Source 
General information 
about you 
Age, gender, education, marital status, 
living situation and place of residence, 
main source of living (own income, 
pension, social security, other), 
household income (at intervals), extent of 
informal care, use of other types of 
welfare technology (security alarm, self-
help tools, etc.) 
Municipal registration 
and questionnaire 
Your use of the GP 
services 
Number of consultations and contacts, 
selected tariffs and measurements, 
number of kroner in the form of 
reimbursement and free cards 
The Norwegian 
Health Economics 
Administration 
Database  
(KUHR), Municipal 
Patient and User 
Register (CPR),  
General practitioner 
register  
Your use of the 
emergency room 
service, appointment 
specialists and 
physiotherapists with 
an operating 
agreement 
Number of consultations and contacts, 
selected tariffs and measurements, 
number of kroner in the form of 
reimbursement and free cards 
The Norwegian 
Health Economics 
Administration 
Database  
(KUHR), Municipal 
Patient and User 
Register (KPR) 
Your use of municipal 
health and care 
services 
Number of visits and time spent on home 
services and practical assistance, 
municipal emergency 24-hour service, 
short-term stays 
Municipal Patient and 
User Register (KPR), 
electronic patient 
record 
Your use of specialist 
health services 
Information on outpatient consultations, 
bed days, admissions including 
procedures and diagnoses 
Norwegian Patient 
Register (NPR) 
Your use of telehealth 
Date of start-up and eventual termination, 
recruitment channel, status, diagnoses, 
assigned technology 
Municipal registration 
Your measurements 
and other records from 
the follow-up service 
Answers to questions about your health, 
measurements of weight, blood sugar, 
blood pressure, oxygen measurement, 
heart rate, spirometry, temperature and 
other measurements from the test 
Follow-up service / 
municipality / 
technical solution 
provider 
Your use of medicines Use of medicines; number, types and 
doses 
Norwegian 
Prescription Database 
(NorPD) 
 
 

 
ANONYMOUS IDENTIFIER * x x x x * 
Telehealth trial: Questionnaire for participants 
You receive this questionnaire because you have agreed to participate in a trial 
of telehealth. 
As part of the trial, you will receive a questionnaire about every six months. You 
will receive a total of four questionnaires during the follow-up period. If you do 
not return the questionnaire within one week, you will first receive a reminder 
by mail, and then a reminder by phone. Norsk Gallup manage the survey on 
behalf of the researchers. 
The questionnaire is about your physical and mental health, your experience and 
satisfaction with the follow-up of your health, as well as background 
information about you. 
Your answers are of great importance, and we appreciate your 
participation! 
If you have any questions related to the survey, please contact Hanna Løyland, 
project member at Oslo Economics, by email at hil@osloeconomics.no. 
 
Physical and mental health 
1. How often do you engage in physical activity of such intensity that 
you become somewhat breathless and/or sweaty? 
 Every day 
 4-6 times per week 
 2-3 times per week  
 Once a week 
 1-3 times per month 
 Less than once a month 
 Never 
2. To what extent do you engage in physical everyday activities such 
as gardening, gardening, walking or cycling as a transport? 
a. To a small extent  
b. To some extent 
c. To a large extent 
d. Do not know  
 
Appendix B: Participant questionnaire 

 
3. To what extent do you feel that you have a healthy diet that meets 
your energy and nutritional needs? 
a. To a small extent  
b. To some extent 
c. To a large extent 
d. Do not know 
 
4. How often do you participate in social activities? 
a. Rarely 
b. Occasionally 
c. Often 
d. Do not know 
 
5. Think about how you have been feeling the past 7 days. To what 
extent did you feel…?  
Note: Only choose one option for each line 
 
Not at all 
To a small 
extent 
To some 
extent 
To a 
large 
extent  
Do 
not 
know  
Happy  
 
 
 
 
 
Enthusiastic 
 
 
 
 
 
Calm and 
relaxed 
 
 
 
 
 
Worried  
 
 
 
 
 
Depressed or 
sad  
 
 
 
 
 
Irritated  
 
 
 
 
 
Lonely  
 
 
 
 
 
Concerned 
 
 
 
 
 
 
 

 
6. Think about the past 7 days, to what extent did you… 
Note: Only choose one option for each line 
 
Not at 
all 
To a 
small 
extent 
To 
some 
extent 
To a 
large 
extent  
Do not 
know 
Have trouble sleeping at 
night?  
 
 
 
 
 
Have trouble with 
oversleeping? 
 
 
 
 
 
Feel weak, with low 
energy? 
 
 
 
 
 
Experience a loss of 
appetite? 
 
 
 
 
 
Eat too much? 
 
 
 
 
 
Feel faint or dizzy? 
 
 
 
 
 
 
7. All in all, how would you rate your health?  
 Very good  
 Good  
 Neither good nor poor  
 Poor  
 Very poor  
 Do not know 
 
8. All in all, how happy are you with your life?  
a. Not happy at all  
b. Dissatisfied 
c. Neither dissatisfied nor satisfied 
d. Satisfied 
e. Do not know  
 
 
 

 
  

 
 
 

 
Monitoring of own healtg 
9. How do you perceive the following? 
Note: Only choose one option for each line 
 
Not at 
all 
To a 
small 
extent 
To 
some 
extent 
To a 
large 
extent  
Do not 
know 
To what extent do you 
feel in control of your 
own health? 
 
 
 
 
 
To what extent do you 
feel that your current 
state of health makes it 
difficult to plan your 
everyday life? 
 
 
 
 
 
To what extent do you 
feel that you understand 
your body’s signals and 
symptoms?  
 
 
 
 
 
To what extent do you 
feel that your current 
state of health makes it 
difficult to realize your 
goals and abilities?  
 
 
 
 
 
To what extent do you 
feel satisfied with the 
follow-up of your health? 
 
 
 
 
 
To what extent do you 
feel that your regular 
general practitioner (GP) 
is adequately involved in 
following up your health? 
 
 
 
 
 
To what extent do you 
feel that you have the 
 
 
 
 
 

 
opportunity to contribute 
to your own treatment? 
 
 
10. On average, during the past month, how did you regsiter measurements 
and/or answer the questionaire on your tablet?  
a. More than once a day 
b. Once a day  
c. 4-6 times per week  
d. 2-3 times per week 
e. Once a week  
f. Less than once a week  
 
11. What type of technology do you use in connection with the follow-up on 
your tablet? Choose more than one option if neccessary  
a. Tablet  
b. Scale  
c. Blood glucose monitor 
d. Blood pressure monitor 
e. Pulse Oximeter 
f. Spirometer 
g. Thermometer 
h. Capnograph 
i. Other  
 
12. 
 Consider the following statements. 
Note: Only choose one option for each line 
 
Disagree Neither 
agree 
nor 
disagree 
Agree 
Do 
not 
know 
Registrations via 
the tablet are 
difficult to carry 
out   
 
 
 
 
Registrations via 
the tablet gives 
me too much 
responsibility for 
my own health 
 
 
 
 

 
The registrations 
via the tablet 
make me feel 
safer in everyday 
life 
 
 
 
 
Follow-up via the 
tablet does not fit 
my health 
condition 
 
 
 
 
Follow-up via the 
tablet does not 
affect my health 
 
 
 
 
Overall, the 
follow-up via the 
tablet is of good 
quality 
 
 
 
 
 
13. 
 To what extent are the following aspects of the follow-up of 
your health via the tablet (telehealth monitoring) important to you? 
Note: Only choose one option for each line 
 
 
 
Not at 
all 
To a 
small 
extent 
To 
some 
extent 
To a 
large 
extent  
Do not 
know/ 
not 
relevant 
That health care 
professionals 
monitor my 
measurements/ 
answers my 
questions  
 
 
 
 
 
Being able to 
monitor my own 
measurements  
 
 
 
 
 
That I can contact 
the follow-up service 
if needed 
 
 
 
 
 

 
That the follow-up 
service sends me tips 
and advice related to 
my health 
 
 
 
 
 
 
 
 
 

 
Background information  
14. 
 What is your gender? 
a. Male 
b. Female 
c. Do not want to answer 
 
15. 
What is your mother tounge? 
a. Norwegian  
b. Swedish, Danish eller Finnish 
c. Other 
d. Do not want to answer 
 
16. 
 In what year were you born? 
 
 
 
 
17. 
What is your highest level of completed education? 
a. Elementary school 
b. Primary and lower secondary school 
c. Upper secondary education 
d. Higher education 
e. Do not want to answer  
 
 
18. 
What is your marital status? 
a. Unmarried 
b. Married/ cohabitant/ registered partner 
c. Widow/widower 
d. Divorced 
e. Separated  
f. Do not want to answer 
 
 
 
 

 
 
19. 
What is your current living situation? 
a. Live alone  
b. Live with children  
c. Live with spouse/ cohabitant/ registered partner 
d. Live with parents/siblings/other 
e. Live in residential care home, nursing home, house-share etc. 
f. Do not want to answer 
 
20. 
 Do you regularly get help or care from someone who does 
not receive a salary to help you?  
(For instance help with personal hygiene, cooking, house cleaning, or 
to keep track of appointments.) 
a. Spouse/ cohabitant/ registered partner 
b. Parents 
c. Children 
d. Neighbour 
e. Friends/ acquaintances 
f. Other family 
g. Other  
h. No, no I do not get help → Go to question 22 
i. Do not want to answer → Go to question 22 
 
 
21. 
 How often do you get help or care from someone who does 
not receive a salary to help you? 
a. Never  
b. Once a month 
c. 2-3 times per month 
d. 1 day per week  
e. 2-3 days per week 
f. 4-5 days per week 
g. 6-7 days per week 
h. Do not want to answer 
 
 

 
22. 
Do you use any of the following technological aids? 
a. Safety alarm 
b. Medication Dispenser 
c. I do not use any of the technological aids mentioned above 
d. Do not want to answer 
 
23. 
What is your main source of income? 
a. Own income 
b. Pension  
c. Social insurance 
d. Other 
e. Do not want to answer 
 
 
24. 
 What is your household’s annual income before tax (salary, 
pension, sickness benefit, social insurance etc.)? 
a. 0-200 000 NOK 
b. 200 000-400 000 NOK 
 
c. 400 000-600 000 NOK 
 
d. 600 000-800 000 NOK 
e. 800 000-1 000 000 NOK  
f. 1-1.2 million 
NOK 
g. 1.2-1.5 million NOK  
h. 1.5-2 million 
NOK 
i. More than 2 million NOK 
 
25. 
Is there anything else you would like to share about the 
measurements/registrations, the tablet, the follow-up and the use 
of the technology?  
Open answer 
 
Thank you for your participation! 
 
 

 
Telehealth trial: Questionnaire for GPs with patients who are participating in the trial 
Definition of telehealth monitoring 
Telehealth monitoring is a broad concept that lacks a clear definition. When we refer to “telehealth monitoring” in 
this survey, we refer to telehealth monitoring provided within the framework of the test conducted by the 
Directorate of Health and your municipality. Below is a brief description: 
Telehealth monitoring means that the patient can be followed up remotely by the health and care service using 
technological solutions. Users of remote monitoring can answer simple questions about their health status via a 
tablet, and take measurements related to their health status (eg blood pressure, weight, O2 saturation). The 
results are transferred from the measuring devices to the tablet so that the patient can easily see them and 
monitor their own results over time. The results are also transmitted digitally to a follow-up service. The response 
service / follow-up service contacts the patient in case of signs of deterioration and measurements beyond what 
are normal values for the individual. They provide medical professional support and guidance based on the 
patient's needs and plan for follow-up, and will, in consultation with the patient, consider whether they should 
contact their GP / emergency room. 
Telehealth monitoring can provide better health and better patient experience through targeted use of health 
care resources. The distance follow-up initiative can come from a general practitioner, a hospital, the patient 
himself or another health professional. It is the GP who, in consultation with the patient, assesses whether distance 
follow-up may be appropriate and professionally justified for the individual. The GP will, together with the 
patient, nurse and any other relevant health personnel, prepare a plan for follow-up based on the patient's 
goals, symptom picture and risk of deterioration. This plan forms the basis for the follow-up content, frequency 
and contact point for the individual. 
Buy "follow-up service", we mean the unit that monitors the registrations the users send via their tablets. The 
follow-up service has different names in different municipalities, including the follow-up service, the telemedicine 
center and the health guard 
 
Inclusion and exclusion criteria:    
The target group of the telehealth trial is patients with chronic diseases, with medium or high risk of worsening of 
one’s condition, risk of re-hospitalization or increased need for health and care service. These patients have a 
high consumption of health care services and the target group consists largely of patients with non-communicable 
chronic diseases such as diabetes, colic, cardiovascular disease, mental disorders and cancer. This group often has 
several diagnoses, complex and large needs, and are in need of follow-up of their diseases.   
Patients who are not competent to consent, patients who cannot use the tablet or the measuring devices, and 
patients with substance use disorders, shall not be included in the trial. 
In this part of the questionnaire we ask how you experience these inclusion and exclusion criteria. 
Appendix C: GP questionnaire 

 
1. To what extent are you familiar with the inclusion and exclusion criteria for participation in the 
telehealth trial (other than they are described above)? 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
 
2. To what extent do you feel that the inclusion criteria for participation in the trial are suitable? 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
 
3. You have stated that you do not at all or to a small extent feel that the inclusion criteria for 
participation in the telehealth trial are suitable. Can you elaborate? 
 
4. What proportion of patients on your patient list do you estimate meet the inclusion criteria for 
telehealth? 
 No one 
 1-4% 
 5-9% 
 10-14% 
 15-19% 
 More than 20% 
 
5. How many patients have you considered for telehealth (by recruiting them yourself or receiving 
a request from the project administration)? 
 
6. How many of these did you consider not suited for participation? 
 
7. What was the reason you considered these people not suited for participation? (More than one 
answer is possible) 
 The patient’s health 
 The patient’s ability to use technology 
 Lack of time for follow-up of patient using telehealth 
 Lack of time to consider and understand what telehealth is 
 Other 
 
8. You have stated that there was another reason why you considered one or more people not 
suited. Can you elaborate? 
 
9. Do you have any other comments related to the inclusion and exclusion criteria for telehealth 
monitoring? 
 
The GP's assessment of the patient's suitability for participation in the trial of telehealth monitoring 
 
In the examination of telehealth monitoring, the Directorate of Health has decided that the general 
practitioner, who is responsible for the patients on his list, must assess whether each patient proposed is 
suitable to participate in the trial. In this section we ask about your opinions on this. 
 
10. Do you think it is right that you as a GP should be involved in the assessment of the patient's 
suitability for telehealth monitoring? 

 
 Yes  
 No 
 
11. You stated that you do not think it is appropriate that you as a GP should evaluate the 
patient's suitability for telehealth monitoring. Can you elaborate? 
 
Recruitment to medical distance monitoring 
In this section we ask questions related to the recruitment to telehealth monitoring. 
12. To what extent do you feel your patients are interested in receiving telehealth monitoring 
(disregarding that the trial is conducted as a randomized controlled trial)? 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
 
13. Have you identified and recruited patients on your list? 
 Yes 
 No 
 
14. How many patients have you recruited? 
 
15. Have you systematically reviewed your patient list to identify patients who may be eligible for 
telehealth monitoring? 
 
16. In what way did you go through your patient list (eg using Medrave)? 
 
17. To what extent has the recruitment of patients for telehealth monitoring been time-consuming? 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
 
18. Do you have any other comments related to the recruitment of patients for the trial of 
telehealth monitoring? 
 
19. How many patients on your list are currently participating in the telehealth monitoring trial (and 
are included in the intervention group)? 
 
20. How much time do you spend in an average month on telehealth monitoring (both recruitment 
and follow-up of patients receiving distance monitoring)? 
 Less than half an hour 
 Between half an hour and one hour 
 Between one and two hours 
 Between three and five hours 
 More than five hours  
 
21. Do you experience any change in the total amount of time you spend (the number of 
consultations and the time per consultation) on an average patient using telehealth monitoring? 
 Time spent is significantly reduced 
 Time spent is somewhat reduced  
 No noticeable change in time spent 
 Time spent is somewhat increased 

 
 Time spent is significantly increased 
 
22. Do you have access to your patients' measurements? 
 Yes, I have direct access via journal system or similar 
 Yes, but only if the patient brings their tablet 
 No 
 
23. To what extent is it useful for you to have access to your patients' measurements? 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
 
Collaboration and interaction 
 
The goals of telehealth monitoring are better patient experience, better (or more stable) physical and 
mental health, and lower costs for the health care services. One way to achieve these goals is by better 
collaboration and collaboration between different parts of the health care services. 
In this section, we ask how you feel that the collaboration with other health care services related to 
telehealth monitoring works. 
 
24. How often do you contact the follow-up service in the following situations? 
• 
Recruitment of patient / user for the trial 
 Never 
 Less than once per month 
 1-2 times per month 
 3-4 times per month 
 More than 4 times a month 
• 
Design of follow-up plan for patient / user participating in the trial 
 Never 
 Less than once per month 
 1-2 times per month 
 3-4 times per month 
 More than 4 times a month 
• 
Follow-up of patient / user participating in the trial  
 Never 
 Less than once per month 
 1-2 times per month 
 3-4 times per month 
 More than 4 times a month 
 
25. How does telehealth monitoring affect your interaction with:? 
• 
Home nursing care unit 
 Much worse interaction 
 Somewhat worse interaction 
 No change in interaction 
 Some better interaction 
 Much better interaction 
• 
Specialist health service 

 
 Much worse interaction 
 Somewhat worse interaction 
 No change in interaction 
 Some better interaction 
 Much better interaction 
 
26. How do you feel that telehealth monitoring affects the coordination and consistency of the 
service provision of the individual patient? 
 I find that the degree of coordination and coherence is reduced 
 I find that there is no change in the degree of coordination and context 
 I find that the degree of coordination and coherence is increasing 
 
27. Do you have any other comments related to the interaction with other healthcare providers? 
 
Satisfaction with and benefits of telehealth monitoring for patients/users 
 
In this section, we ask about how you perceive that telehealth monitoring affects the users. 
 
28. To what extent do you feel that the users are satisfied with telehealth monitoring? 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
 
29. To what extent do you feel that telehealth monitoring contributes positively to users ...? 
• 
Physical health 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
• 
Mental health 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
• 
Security 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
• 
Coping with own illness 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
 

 
30. To what extent do you feel that telehealth monitoring helps patients / users become more 
involved in the follow-up of their own illness? 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
 
31. Do you experience a change in the proportion of immediate help appointments among patients 
receiving telehealth monitoring? 
 I experience a reduction in the proportion of immediate help appointments 
 I do not experience any change 
 I experience an increase in the proportion of immediate help appointments 
 
Claims related to telehealth monitoring 
 
32. Consider the following claims regarding telehealth monitoring. 
• 
Telehealth monitoring can contribute to unnecessary disease focus among some 
users 
 Strongly disagree 
 Disagree 
 Neither agree nor disagree 
 Agree 
 Strongly agree 
• 
Telehealth monitoring can contribute to increased security for relatives 
 Strongly disagree 
 Disagree 
 Neither agree nor disagree 
 Agree 
 Strongly agree 
• 
Telehealth monitoring can help to more accurately assess users' needs for health 
care 
 Strongly disagree 
 Disagree 
 Neither agree nor disagree 
 Agree 
 Strongly agree 
• 
Telehealth monitoring can help to identify the need for health care that the user 
would otherwise not require 
 Strongly disagree 
 Disagree 
 Neither agree nor disagree 
 Agree 
 Strongly agree 
• 
Telehealth monitoring can help save resources for the GP services 
 Strongly disagree 
 Disagree 
 Neither agree nor disagree 
 Agree 
 Strongly agree 
 

 
33. What do you think are the biggest challenges for implementing telehealth monitoring as a 
national measure in the future? 
 
34. Do you have any other comments related to telehealth monitoring? 
 
Background information 
 
35. In which municipality do you work? 
 Bodø 
 Eid  
 Kristiansand 
 Larvik 
 Oslo 
 Ullensaker 
 Gjerdrum 
 Other municipality in Agder 
 Other municipality 
 
36. In which urban district do you work? 
 Alna  
 Bjerke  
 Frogner  
 Gamle Oslo 
 Grorud  
 Grünerløkka  
 Nordre Aker  
 Nordstrand  
 Sagene  
 St. Hanshaugen  
 Søndre Nordstrand 
 Ullern  
 Vestre Aker  
 Østensjø 
  
 
 
37. Do you participate as a GP in the trial of primary health care teams? 
 Yes  
 No 
 
38. What is your gender? 
 Male 
 Female 
 
39. How old are you? 
 Younger than 30 years 
 30-39 years 
 40-49 years 
 50-59 years 
 60 years or older 
 
40. How many years have you worked as a GP? 
 Less than 1 year 
 1-2 years 

 
 3-4 years 
 5-9 years 
 10 years or more 
 
41. What is your highest level of completed education? 
 Cand. Med. 
 Authorized physician LIS1 
 Specialist in general medicine 
 Specialist in other domain 
 
42. Do you have any comments related to this survey? 
 

 
 
Notat, 22. oktober 2019                      58 
 
Telehealth trial: Questionnaire for employees in the follow-up service 
Inclusion and exclusion criteria:    
The target group of the telehealth trial is patients with chronic diseases, with medium or high risk of 
worsening of one’s condition, risk of re-hospitalization or increased need for health and care service. 
These patients have a high consumption of health care services and the target group consist largely of 
patients with non-communicable chronic diseases such as diabetes, colic, cardiovascular disease, mental 
disorders and cancer. This group often has several diagnoses, complex and large needs, and in need 
of follow-up of their diseases.   
Patients who are not competent to consent, patients who cannot use the tablet or the measuring devices, 
together with patients with substance use disorders, shall not be included in the trial. 
In this part of the questionnaire we ask how you experience these inclusion and exclusion criteria. 
1. To what extent do you experience that the inclusion and exclusion criteria are well suited for 
telehealth monitoring?  
 Not at all  
 To a small extent  
 To some extent  
 To a large extent  
 To a very large extent 
 
2. You have stated that you do not at all, or to a small extent, feel that the inclusion criteria for 
participation in the telehealth trial are suitable. Can you elaborate? 
 
3. Do you have any comments related to the inclusion and exclusion criteria for the telehealth 
trial? 
 
The general practitioner’s assessment of the patient's suitability for participation in the trial of 
medical distance follow-up:   
In the telehealth trial the Directorate of Health has decided that the general practitioner, as a medical 
professional responsible for the patients on his/her list, must assess whether each proposed patient is 
suited to participate in the trial. In this section we ask about your opinions on this. 
 
4. Do you think it is right that it is mandatory that the GP participates in the assessment of the 
patient's suitability for telehealth monitoring? 
 Yes  
 No 
 
5. You answered that you do not think it is right that it is mandatory that the GP participates in 
the assessment of the patient's suitability for telehealth monitoring. Can you elaborate?  
 
Your time spent:   
In this part we ask about we ask you how you allocate your working time to different tasks. Think of an 
average work week. 
6. How large is your overall job percentage related to telehealth follow-up? 
Appendix D: Follow-up service questionnaire 

 
 
Notat, 22. oktober 2019                      59 
 0-20 
 21-40 
 41-60 
 61-80 
 81-100 
 
7. Indicate (approximately) the percentage of your total working time spent on the following 
tasks related to telehealth monitoring?  [indicate one number per line] 
• 
Recruiting new patients (including information meetings, training/instruction, ancillary 
working and interdisciplinary work with the patients plan for follow-up) 
• 
Phone calls with patients  
• 
Assessment of measurements / results 
• 
Communication with the GP (not interdisciplinary meetings in connection to starting the 
patient up with telehealth monitoring), other primary health care or specialist health care 
• 
Other 
 
Collaboration and interaction 
The goals of telehealth monitoring are improved patient experience, improved (or more stable) 
physical and mental health, and lower costs for the health care services. One way to achieve these 
goals is by improved collaboration and collaboration between different parts of the health care 
services.  
In this section, we ask how you feel that the collaboration with other health care services related to 
telehealth monitoring works. 
8. How does interaction with the following actors work related to the organization of telehealth 
monitoring in your municipality: 
 
 
Very poorly  
Poorly  
Neither poorly 
nor well 
Well 
Very well 
Home care 
services 
(home 
nursing, BPA, 
everyday 
rehabilitation 
etc.) 
 
 
 
 
 
The GP 
service  
 
 
 
 
 
Specialist 
health 
service 
 
 
 
 
 
 
9. You have answered that the interaction with one or more actors works poorly or very poorly. 
Can you elaborate? 
 
10. How does interaction with the following actors work related telehealth monitoring of each 
individual patient: 
 

 
 
Notat, 22. oktober 2019                      60 
 
Very poorly  
Poorly  
Neither poorly 
nor well 
Well 
Very well 
Home care 
services 
(home 
nursing, BPA, 
everyday 
rehabilitation 
etc.) 
 
 
 
 
 
The GP 
service  
 
 
 
 
 
Specialist 
health 
service 
 
 
 
 
 
 
11. You have answered that the interaction with one or more actors works poorly or very poorly. 
Can you elaborate? 
 
12. How do you feel that telehealth monitoring affects the coordination and consistency of the 
service provision of each individual patient?  
 
• 
I find that the degree of coordination and coherence is reduced 
• 
I find that there is no change in the degree of coordination and context 
• 
I find that the degree of coordination and coherence is increasing 
 
13. Do you have any further comments related to the interaction with other actors in the health 
service?  
 
Satisfaction with and benefits of telehealth monitoring for patients/users 
In this section, we ask about how you perceive that telehealth monitoring affects the users. 
 
14. To what extent do you feel your patients are interested in receiving telehealth monitoring 
(disregarding that the trial is conducted as a randomized controlled trial)? 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 
Do not know 
 
15. To what extent do you feel that the users are satisfied with telehealth monitoring? 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
 
16. To what extent do you feel that telehealth monitoring contributes positively to users ...? 
• 
Physical health 

 
 
Notat, 22. oktober 2019                      61 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
• 
Mental health 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
• 
Security 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
• 
Coping with own illness 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
 
17. To what extent do you feel that telehealth monitoring helps patients / users become more 
involved in the follow-up of their own illness? 
 Not at all  
 To a small extent  
 To some extent 
 To a large extent 
 Do not know 
 
Claims related to telehealth monitoring 
 
18. Consider the following claims regarding telehealth monitoring. 
• 
Telehealth monitoring can contribute to unnecessary disease focus among some 
users 
 Strongly disagree 
 Disagree 
 Neither agree nor disagree 
 Agree 
 Strongly agree 
• 
Telehealth monitoring can contribute to increased security for relatives 
 Strongly disagree 
 Disagree 
 Neither agree nor disagree 
 Agree 
 Strongly agree 
• 
Telehealth monitoring can help to more accurately assess users' needs for health 
care 
 Strongly disagree 
 Disagree 
 Neither agree nor disagree 

 
 
Notat, 22. oktober 2019                      62 
 Agree 
 Strongly agree 
• 
Telehealth monitoring can help to identify the need for health care that the user 
would otherwise not require 
 Strongly disagree 
 Disagree 
 Neither agree nor disagree 
 Agree 
 Strongly agree 
 
19. What do you think are the biggest challenges for a national implementation of telehealth 
monitoring in the future? 
 
20. Do you have any other comments related to telehealth monitoring? 
 
Background information 
In this section we ask a few background questions for use in the statistical analysis 
21. In which municipality do you work? 
 Bodø 
 Eid  
 Kristiansand 
 Larvik 
 Oslo 
 Ullensaker 
 Gjerdrum 
 Other municipality in Agder 
 Other municipality 
 
22. What is your gender? 
 Male  
 Female 
 
23. How old are you? 
 Younger than 30 years 
 30-39 years 
 40-49 years 
 50-59 years 
 60 years or older 
 
24. What is your highest level of completed education? 
 Licenced practical nurse 
 Bachelor’s in nursing 
 Master’s in nursing  
 Other 
 
25. Do you have any comments related to this survey?