Patient Empowerment: Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease for Better Quality of Treatment
Phase: NA
Conditions: Inflammatory Bowel Disease, Ulcerative Colitis, Crohn´s Disease
Sponsor: Hvidovre University Hospital

ClinicalTrials.gov Identifier: NCT01860651 
Title: 
Patient Empowerment: Web-based Monitoring in Children and Adolescents With Inflammatory 
Bowel Disease for Better Quality of Treatment 
ClinicalTrials.gov Identifier: NCT01860651. Registered May 2013 
Danish Ethical Committee: Journal number H- 2-2013-061), 
Danish Data Protection Agency: Journal number HVH-2014-004) 
Date: June 24, 2013, updated November 3, 2017 

ClinicalTrials.gov Identifier: NCT01860651 
DISPOSITION: 
 
STUDY PROTOCOL ............................................................................................................................................. 3 
Hypothesis ..................................................................................................................................................... 3 
Background .................................................................................................................................................... 3 
Clinical relevance at different levels .............................................................................................................. 3 
Study design .................................................................................................................................................. 4 
Project description: ....................................................................................................................................... 5 
STATISTICAL ANALYSIS PLAN ............................................................................................................................. 8 
REFERENCES ...................................................................................................................................................... 9 
PUBLICATIONS FROM THE STUDY ..................................................................................................................... 9 
INFORMED CONSENT FORM (A) ...................................................................................................................... 10 
INFORMED CONSENT FORM (B) ...................................................................................................................... 14 
 
 
 
 
 

ClinicalTrials.gov Identifier: NCT01860651 
STUDY PROTOCOL 
Hypothesis 
Adherence to medicine in young chronic patients is low and difficult to achieve. It is our hypothesis, that 
adherence can be optimized by integrating young patients with chronic inflammatory bowel diseases (IBD), 
in their own disease course and support their empowerment by using an E-health web-based monitoring. 
 
Background 
The two inflammatory bowel diseases, Ulcerative Colitis (UC) and Crohn´s Disease (CD), constitute the 
majority of IBD. In Denmark the prevalence of IBD is approximately 35.000 patients and 10-15 % is pediatric 
patients.  
 
E-health 
Previous studies have used E-health in the treatment of adult IBD patient: In one study including 300 
patients with mild-to-moderate ulcerative colitis (UC), E-health treatment resulted in shortening periods of 
active disease (average 18 vs. 77 days in the control group). 88% were satisfied with their treatment using 
E-health and the need for outpatient visits was reduced[1]. In another study on 27 patients with CD treated 
with biologicals, E-Health was able to optimize the timing of the infusion of infliximab according to the 
disease activity, resulting in longer periods between the infusions[2]. The E-health solution was safe and 
patients demonstrated an adherence to the program of 86%. To our knowledge no study has previously 
used E-health treatment in adolescence with IBD. E-health is probably even better accepted by this group 
of patients, as web communication is a wellintegrated part of young patients daily lives. 
 
Clinical relevance at different levels 
Individual 
By involving patients in their own treatment through education and by the use of the E-health program it is 
expected to increase the patient adherence and empowerment and thereby to ensure treatment quality. 
The interaction between patient and doctor through the E-health program is expected to provide a more 
continuous disease handling without delays and increase patient satisfaction. Since “web-rounds” (doctor 
checking the patient´s web-site) do not require the presence of patient and doctor at the same time, the 
patients avoid taking time off from school/education/work to attend the out-patient clinic for control visits 
when their disease is in remission. 
 
Departments 
Using the E-health program for disease monitoring will create the opportunity to reorganize the treatment 
of patients with chronic diseases. Avoiding "unnecessary" outpatient visits when the disease is in remission 
will make it possible to concentrate on consultations when the disease is active. Web-rounds are part of 
the DRG registration (economic system between government, regions and departments). 
 
Aim 
Through E-health intervention to 
- Increase patient´s own responsibility for the treatment and thereby better adherence and support patient 
empowerment 
- Reduce patient’s: 
i) Disease activity 
ii) Need for surgery 
iii) Days of absence from school 

ClinicalTrials.gov Identifier: NCT01860651 
v) Need for outpatient visits 
and  
VI) Optimize the timing of infliximab treatment. 
 
Study design 
The study consists of two projects: 
Study 1 (for the following: Project Web-Home-Med): A prospective study including IBD patients treated with 
non-biological treatment. Patients will be randomized to an E-health group or control group.  
 
Study 2 (for the following: Project Web-Biologicals) : A prospective descriptive study including IBD patients 
treated with biological infusions (Infliximab). The participations have to use an E-health program in order to 
optimize the timing of infusions.  
 
E-health 
Using the E-health program consists of following: 
- An education lesson about the disease and how to use the web-programme 
- Registering symptoms through validated disease activity indexes 
- Sending in fecal samples for analysis of fecal calprotectin (FC) 
- Deliver blood test 
- Filling out questionnaires about: self-rated adherence, status of health, days of absence from school and 
hospitalizations 
 
The E-health web-program is monitored by the project physician and patients’ records are assessed, 
ensuring the appropriate follow-up. In the E-health program the symptom scores are presented to the 
patient via a simple traffic light chart and demonstrate the course of disease activity over time. Figure 1 
 
Figure 1.Example from adult constant-care.dk 
 
 
 
 
The study will be performed at the Pediatric Department, Hvidovre University Hospital and include IBD 
patients aged 10-17 years. The patient will be followed for two years. 
 
 
 

ClinicalTrials.gov Identifier: NCT01860651 
Project description: 
 
Project Web-Home-Med E-health group and Project Web-Biologicals 
The E-health intervention consists of education about the disease and about use of the web-program. E-
health group, project Web-Home-Med also includes an annual consultation at an IBD center.  
 
Education 
Patients and their parents will be informed about the disease and how to use the web-program during an 
one hour information session. The participant learns about the symptoms of active disease and how they 
must be registered in the web program. Patients are instructed to consult a doctor if they have any of the 
following alarm symptoms: 
-More than six stools per day 
-Daily fresh blood in the stool (at each defecation) 
-Fever (temperature > 37.5 ° C) 
-Severe abdominal pain and / or tenderness 
-Acute to severe exacerbation of symptoms. 
Patients are reminded that there are no restrictions on contacting their doctor, if the need arises. 
 
E-health intervention  
Each participating patient will receive a username and password to log on to the web-program. All personal 
data will be kept under secure conditions in accordance with the Danish Data Protection Agency’s rules and 
only the physician related to the project will have access to the personal data. The personal website 
indicates which forms the participant must complete. 
 
Registering symptoms 
The web-program requires that the participants complete disease activity scores: Pediatric Ulcerative Colitis 
Activity Index (PUCAI)[3] for UC patients and abbreviated Pediatric Crohn’s Disease Activity Index 
(aPCDAI)[4] for CD patients. 
 
The scores from PUCAI and aPCDAI are presented to the patient via a simple traffic light chart which shows 
whether the patient, depending on the severity of disease activity, is in the green (mild), yellow (moderate) 
or red (severe) zone. On the chart, the participants can see the course of disease activity over time. In 
Project Web-Home-Med, participants must register symptoms every four weeks, in Project Web-Biologicals, 
they must do so weekly for the first four weeks after infliximab treatment. 
 
Fecal calprotectin 
In project Web-Home-Me., the patients will be asked to take a stool sample for FC at baseline and 
thereafter every three months. If disease activity is worsening, i.e. the patient is in the yellow or red traffic 
light zones, extra FC analysis will be needed. In project Web-Biologicals, patients will be asked to send in 
fecal samples for FC analysis four weeks after infliximab treatment and weekly thereafter.  
 
The laboratory performs all FC analysis and enters the results in the web-program so that both patient and 
doctor are informed about the FC level. Scores from PUCAI and PCDAI will be added with FC scores to yield 
the total inflammations score (TIBS), which will be presented as a traffic light colour as well. 
 
Blood tests 
Every three months participants in Project Web-Home-Med. are asked to take a routine blood test at either 
a local laboratory or at Hvidovre University Hospital. Blood samples are similar to the standard IBD-package 

ClinicalTrials.gov Identifier: NCT01860651 
of blood tests with which laboratories are already familiar. For patients in Project Web-Biologicals, the 
routine blood samples are taken prior to infliximab infusion. 
 
Blood test results will be reviewed by the project physician and compared with symptom scores on the 
web-program. Both the effects of the treatment and the side effects, in the form of bone marrow 
suppression, will be evaluated. If the patient's blood test results fall outside the acceptable limits, the 
patient will be contacted by telephone for a consultation with a pediatric specialist. Blood sample results 
within acceptable limits will be indicated on the patient’s personal web page. In project Web-Biologicals 
Infliximab concentration and antibodies will be measured as well. 
 
Self-rated adherence and Quality of life 
Participants in Project Web-Home-Med. must assess their adherence to treatment using a Medicine 
Adherence Report Scale (MARS)[5] and a Visual Analog Scale (VAS). VAS is a 10 cm long line, representing 
the spectrum from always taking medicine to never. The patients have to set a mark representing how 
often they take the medicine.  
 
To assess the patient’s quality of life, participants in both projects completes the “IMPACT III” questionnaire 
(questionnaire for children and young people about general condition). IMPACT III is developed by the 
Pediatric Inflammatory Bowel Disease Working Group on Quality of life represented by Dr. Anthony Otley, 
Canada [6]. Through cooperation with the Quality of life group the questionnaire is certificated in Danish 
after a cross-cultural adaptation, including a forward and backward translation and a cognitive debriefing 
(validation of the questions). 
 
MARS, VAS and IMPACT III have to be entered every three months in project Web-Home-Med. and every 
four week plus before the infusion of infliximab, in project Web-Biologicals, 
 
Web-rounds 
The web-program is monitored by the project physician and patients’ records are assessed. If a patient’s 
symptoms progresses to the yellow or red zones, the website advises the patient to send in a stool sample 
for FC analysis. If the patient are in severe and moderate disease activity (the yellow and red zone), they 
are requested to contact the project physician. The patient will be contacted by the project physician, if the 
patient does not contact the physician, to ensure appropriate follow-up. 
 
If a patient progresses to the yellow or red zones in project Web-Biologicals, the patient will be contacted 
by the project physician and will be offered infliximab treatment within a few days. If the patient remains in 
the green zone, infliximab treatment will postponed for a maximum period of 12 weeks. 
 
Registration of medical treatment  
On the web-program, participants in project Web-Home-Med register their prescribed medication. In 
project Web-Biologicals, only infliximab treatments are registered, as patients’ other medical treatment 
remains unchanged during the project. 
 
Reminder 
Patients are reminded every four weeks or weekly (depending on the project) via SMS to log on to the web 
program for symptom scoring, as well as when they need to give blood samples or submit stool samples. 
 
Smartphone  
The web-program is also designed for use on smart phones, and is therefore easily integrated into the 
patient's daily life. 
 

ClinicalTrials.gov Identifier: NCT01860651 
Project Web-Home-Med, annual control at IBD-center 
Once a year, the patients will have a prolonged consultation (two or three hours) at the IBD center, during 
which patients will be thoroughly examined by a pediatric gastroenterology specialist and IBD-nurses.  
 
Project Web-Biologicals, treatment 
Treatment is initiated if the patient has active disease or a maximum of 12 treatment-free weeks have 
occurred. The initiated treatment follows the usual guidelines for IBD treatment. 
 
Contact 
Patients are informed that they can call or send an e-mail to the project physician if they need additional 
support or information. Patients are in no way discouraged from using the emergency medical contact if 
they feel it necessary. 
 
Project Web-Home-Med: control group 
Patients randomized for the control group follow the usual guidelines with visits in the out-patient clinic 
every third month. At each consultation blood samples will be taken and patients asked to bring a fecal test 
for FC analysis. In addition to the usual control visits, patients complete forms adherence (VAS and MARS) 
and quality of life (IMPACT). Furthermore they will be asked to keep track of the number of lost school days 
per month and what medications they currently take. The questionnaires are completed in the clinic. 
 
Collection of data from prescription database and electronic patient file (e-journal). 
Information from the prescription database is obtained to check whether the prescribed medication is 
collected by the patients. Any hospitalization is recorded by the doctor in the e-journal. 
 
 
 
 

ClinicalTrials.gov Identifier: NCT01860651 
STATISTICAL ANALYSIS PLAN 
Project A (Project Web-Home-Med): 
Power calculation was made on the basis of a mean Medication Adherence Report Scale (MARS) score of 
20,67; SD 4,01[5]. Using a power of 80%, a significance level of 5%, and an actual difference of 3 on the 
MARS scale, 58 participants were needed. 
 
Results: 
Data were analyzed as intention to treat. Because of the non-parametric distribution of outpatient visits 
and hospitalizations the Wilcoxon sum rank test was used to compare the web and control group. T-test 
was used to compare absence from school between the two groups. To account for the longitudinally-
collected data, alterations during the observed period comparing the web and control group regarding 
disease activity (symptom score, blood test and FC) and medical adherence were analyzed using a mixed 
effect model (MEM). MEM models included a random patient effect and a fixed effect interaction between 
group and time, to evaluate difference between the groups over time. Further adjustment variables that 
were included are listed below for the specific models. Time to drop out, first on-demand visit, and step-up 
in treatment were analyzed by Kaplan Meier survival analysis. P-value <0.05 was considered as significant.  
 
Project B (Project Web-Biologicals):  
Results: 
Demographic values and treatments, and blood samples were described by frequency (percent), median 
(range), and mean (SD). To account for the repeated measures, Mixed Effect Models (MEM) were used to 
compare the eHealth and control groups regarding lengths of treatment intervals, IFX doses, and IFX trough 
concentrations. The association between IFX concentration and treatment intervals was also analyzed by 
MEM. Comparison of the number of patients developing antibodies to IFX was analyzed by Fisher’s exact 
test. The first and final HRQoL score for each patient were compared using a paired t-test. p values <0.05 
were considered as significant.  
 
Statistical analyses were performed using SAS Enterprise Guide 7.1 and the statistical computing program R 
3.2.2, R Core Team 2015 (R: A language and environment for statistical computing, R Foundation for 
Statistical Computing, Vienna, Austria. URL https://www.R-project.org/).  
 
Ethical issues 
The trial was approved by the Danish Ethical Committee (Jr. H- 2-2013-061) and the Danish Data Protection 
Agency (Jr. HVH-2014-004). It was registered on www.clinicaltrials.gov in May 2013 (ClinicalTrials.gov 
Identifier: NCT01860651). All patients and their guardians gave oral and written consent prior to their 
inclusion in the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 

ClinicalTrials.gov Identifier: NCT01860651 
REFERENCES 
 
[1] 
Elkjaer M., Shuhaibar M., Burisch J., Bailey Y., Scherfig H., Laugesen B., Avnstrøm S., Langholz E., 
O’Morain C., Lynge E., et al. E-health empowers patients with ulcerative colitis: a randomised 
controlled trial of the web-guided “Constant-care” approach. Gut 2010; 59(12): 1652–61. Doi: 
10.1136/gut.2010.220160. 
[2] 
Pedersen N., Elkjaer M., Duricova D., Burisch J., Dobrzanski C., Andersen NN., Jess T., Bendtsen F., 
Langholz E., Leotta S., et al. EHealth: Individualisation of infliximab treatment and disease course via 
a self-managed web-based solution in Crohn’s disease. Aliment Pharmacol Ther 2012; 36(9): 840–9. 
Doi: 10.1111/apt.12043. 
[3] 
Turner D., Otley AR., Mack D., Hyams J., de Bruijne J., Uusoue K., Walters TD., Zachos M., Mamula P., 
Beaton DE., et al. Development, validation, and evaluation of a pediatric ulcerative colitis activity 
index: a prospective multicenter study. Gastroenterology 2007; 133(2): 423–32. Doi: 
10.1053/j.gastro.2007.05.029. 
[4] 
Turner D., Griffiths AM., Walters TD., Seah T., Markowitz J., Pfefferkorn M., Keljo D., Waxman J., 
Otley A., LeLeiko NS., et al. Mathematical weighting of the pediatric Crohn’s disease activity index 
(PCDAI) and comparison with its other short versions. Inflamm Bowel Dis 2012; 18(1): 55–62. Doi: 
10.1002/ibd.21649. 
[5] 
Ediger JP., Walker JR., Graff L., Lix L., Clara I., Rawsthorne P., Rogala L., Miller N., McPhail C., Deering 
K., et al. Predictors of medication adherence in inflammatory bowel disease. Am J Gastroenterol 
2007; 102(7): 1417–26. Doi: 10.1111/j.1572-0241.2007.01212.x. 
[6] 
Otley A., Smith C., Nicholas D., Munk M., Avolio J., Sherman PM., Griffiths AM. The IMPACT 
questionnaire: a valid measure of health-related quality of life in pediatric inflammatory bowel 
disease. J Pediatr Gastroenterol Nutr 2002; 35(4): 557–63. 
 
 
PUBLICATIONS FROM THE STUDY 
Carlsen K., Jakobsen C., Houen G., Kallemose T., Paerregaard A., Riis LB., Munkholm P., Wewer V. Self-
managed eHealth Disease Monitoring in Children and Adolescents with Inflammatory Bowel Disease: A 
Randomized Controlled Trial. Inflamm Bowel Dis 2017; 23(3): 357–65. Doi: 
10.1097/MIB.0000000000001026 
Carlsen K., Jakobsen C., Hansen L., Paerregaard A., Munkholm P., Wewer V. Personalized infliximab 
treatment of adolescents with inflammatory bowel disease. J Crohn’s Colitis 2014; 8(Conference 
Publication: (var.pagings). 8 (pp): s408. Doi: 10.1017/CBO9781107415324.004. 
 
 
 
 

ClinicalTrials.gov Identifier: NCT01860651 
INFORMED CONSENT FORM (A) 
Patient Empowerment: Web-based Monitoring in Children and Adolescents With Inflammatory 
Bowel Disease for Better Quality of Treatment 
Project A (Project Web-Home-Med) 
 
 
Purpose of the project 
The aim of the project is to ensure better treatment for children and adolescents with inflammatory bowel 
disease, i.e. patients who have one of the two diseases: Crohn's disease or Colitis Ulcerosa. 
 
Our aim is through the E-health intervention to 
- Increase patient´s own responsibility for the treatment and thereby better adherence and support patient 
empowerment 
- Reduce a patient’s: 
i) Disease activity 
ii) Need for surgery 
iii) Days of absence from school and 
v) Need for outpatient visits 
 
We will try to achieve the goals by using a personal website for young patients with inflammatory bowel 
disease. 
 
Randomization and distribution in groups 
Since it is a scientific experiment, it is necessary to have a group that tests the website and a group 
following the usual treatment. The groups are compared and this is important in order to determine if it 
helps to use the website. Therefore, your son/daughter will, if he/she chooses to participate in the trial, 
participate in a random draw, to be followed by a web group or a control group. It is equally important for 
the experiment whether your child is in one or another group. 
 
We hope to include 70 patients in the project, ie. 35 participants in each group, all aged 10-17 years. Below 
are the procedures described in the web group and the control group, respectively. Will we follow the 
participants this way for two years. 
 
Usefulness of the experiment 
By participating in the experiment, whether your child is in the web or control group, your child will in 
future help other children and adolescents with inflammatory bowel diseases as we hope to ensure 
treatment quality. 
 
Risks, side effects and disadvantages 
Overall, there is no risk associated with participation in the project. There are no risks involved in taking 
bowel tests, nor are there any risks associated with blood sampling. Personal information will be stored on 
a secure computer that is subject to the Data Inspectorate's rules and complies with the applicable law on 
the processing of personal data. Users of the system, patients or patient's doctor (if the doctor has patient 
acceptance) may at any time request their personal data deleted. 
 
Exclusion and discontinuation of tests 
It is voluntary to participate in the trial. You may, at any time and without giving a reason, withdraw your 
consent for your child's participation in the project. It will not affect your child's further treatment. 

ClinicalTrials.gov Identifier: NCT01860651 
 
The website has been tested on adult patients without any security issues when using the disease 
monitoring website. Therefore, we do not expect circumstances to arise that can lead to the interruption of 
the experiment. If the project should cause harmful effects, the project will be completed and you will be 
informed accordingly. 
 
Consent for your child's participation in the trial involves giving you access to the relevant authorities as 
part of their control of the trial, obtaining necessary information about the health status of the subject. The 
authorities are subject to secrecy. 
 
If your child is randomized to the web group: 
The web group uses a personal website and each participant is assigned a personal login and password. On 
the website your son/daughter must record symptoms. Answers from bowel tests and blood tests are also 
included. The website is structured as a three-color scheme: red, yellow green, as a traffic light, and 
represents severe, medium and mild level of disease activity. 
 
When symptoms are entered, the computer shows whether your child's disease activity is similar to severe, 
medium or mild disease activity. Along with responses to bowel tests, the computer calculates how active 
the disease is. As your child scores his symptoms, a curve will show the disease activity over time. Your 
son/daughter can thus keep track of how activity in the disease develops. Depending on whether the graph 
moves in green, yellow or red zone, the following must be done: 
Green: Continue the ongoing treatment 
Yellow: Call a doctor 
Red: Call a doctor and order a time to get in control of the day hospital 
 
Another aim of using the website is to make your child aware that he/she must remember to take his/her 
medication. We know it's hard to remember to take medicine every day. With the website it becomes clear 
that you should take your medicine, as it is important to maintain the disease activity in green areas. 
 
Plan of the experiment and what should your child do: 
The trial will continue for 2 years. You will initially be invited to a meeting with a project doctor who will 
teach your child to use the website and explain what symptoms you should be aware of. After your 
son/daughter has learned how to use the website, the participation can start. 
 
Symptoms and Health: Your child must enter his/her symptoms once a month and answer questions about 
his overall health every three months. 
 
Blood tests: Your child must have taken blood samples every 3 months. Blood samples are taken at the 
laboratory that you usually use, and the same tests are taken as during normal treatment. There will be 
deprived 18 ml of blood. 
 
Fecal tests: Every 3 months a feces test for inflammation should be submitted. A “easy-sampler-set” is 
provided for use to take the stool test. This includes gloves, plastic pipes and a piece of paper that can be 
put on the toilet that keeps the stool. After the sample has been removed, the paper can be flushed in the 
toilet. The quantity of the fecal sample should size a hazelnut (equivalent to 10 grams.) 
 
SMS reminder: A text message will be sent to your son/daughter with a reminder of when to enter 
symptoms, submit a bowel test and to take blood samples. 
 

ClinicalTrials.gov Identifier: NCT01860651 
Medicine intake: In a schedule, your son/daughter marks how adherent to the medicine he/she thinks 
he/she is. 
  
Health, well-being and hospitalization: Every 3 months a schedule regarding your childs general health and 
well-being needs to be completed. Furthermore, the number of school absence days and whether there 
have been any hospitalizations. If there have been hospitalizations, a doctor will gather information from 
your child's journal on when, for how long and for what reason, the hospitalization expired. 
 
Only your child, you and the doctor have access to the website. The doctor has access to follow the 
symptoms so that you can contact you if necessary. You can always contact a doctor or other doctor if 
necessary and acute deterioration. 
 
As this is the first time we use the website, we will also ask your son/daughter about how it was to use the 
website and whether it should be changed. Since there are upcoming patients who have the same illness 
and age as your child who needs the website, the answers will be useful for the further development of the 
website. 
 
Smartphones 
The web page is made feasible to smartphones, which allows your child to enter symptoms regardless of 
where he/she is. We want to make it as easy for your child as possible to use the program. 
  
Follow up once a year in the IBD center 
Once a year, your child will be seen in the IBD center for a 2-3 hour continuous check. Here your child will 
be seen by both a nurse and a doctor. 
 
Handling of biological material 
All biological material, i.e. blood and bowel tests will be linked to a participant number, that is, all samples 
will be encoded but can be relegated to the relevant CPR number by project physicians if necessary. When 
data will be analyzed and presented, it is after coded data, why personal information will not appear. 
Blood samples are analyzed immediately as soon as the laboratories receive the samples and material that 
is not used will be destroyed. Excessive feces are stored in a biobank for later scientific research. The 
samples are encoded by participant number so personal information is not displayed. 
 
10 years after end of the study, all data and samples from the project will be destroyed. 
 
However, if you do not want your child to participate in the project, he/she may be destroyed if you wish. 
 
If your child comes in the control group: 
If your child is assigned to participate in the control group, you will be monitored with regular follow ups at 
the hospital every three months. In connection with the controls, your child need to deliver blood and fecal 
tests. When you meet up for in the clinic, we will ask your son/daughter to fill out the forms of general 
health and number of school days missed due  to the illness. In addition in a schedule, your son/daughter 
marks how adherent to the medicine he/she thinks he/she is. The doctor who sees your child for the check-
up time, does not know what your child is responding on the adherence schedules. 
 
Information about economic conditions 
The website is founded on the idea of professor Pia Munkholm, consultant in adult gastrointestinal 
diseases, Herlev Hospital. The project is organized by PhD student Katrine Carlsen with close guidance from 
senior consultant in pediatrics, Vibeke Wewer and consultant Pia Munkholm. Trial manager is not affiliated 
with support providers. 

ClinicalTrials.gov Identifier: NCT01860651 
 
The project is covered by mutual funds and is supported by: European Crohn´s and Colitis Organization, 
Queen Louise´s Hospital Foundation, Tryg Foundation, CALPRO A/S, Tillotts Pharma, Capital Region 
Denmark, Alice and Frimodts Foundation, Ulcerative Colitis and Crohn´s Danish Patient Society, MSD, and 
Promonitor/Orion Diagnostica. 
Access to experimental results 
Ongoing results from the project will be presented at the annual family home evening at the IBD Center at 
Hvidovre Hospital, where you are welcome to come and hear about the project. In addition, the results of 
the trial will continuously be printed in international journals, as well as presented at international and 
national congresses. All data from participants will be anonymized, which means that participants in the 
project cannot be identified. The trial will be completed in January 2016, after which data will be analyzed 
and described. 
 
More information 
In addition to this written information, we will also provide you with oral information about the project. 
This, you will be invited to if you are interested in participating. If you would like to know more about the 
experiment, please feel free to contact us at the contact details below. You must sign a permit for your 
child to be part of the project. We need a signature from both mother and father. We also ask you to read 
the last page for "The subject's rights in a health science research." 
 
 

ClinicalTrials.gov Identifier: NCT01860651 
INFORMED CONSENT FORM (B) 
Patient Empowerment: Web-based Monitoring in Children and Adolescents With Inflammatory 
Bowel Disease for Better Quality of Treatment 
 
Project B (Project Web-Biologicals) 
 
 
Purpose of the project 
The aim of the project is to optimize the treatment with biological drug (Infliximab). The aim is to time the 
infusions when it is most appropriate in relation to the disease activity. This means that treatments can be 
given before 8 weeks or up to a maximum of 12 weeks apart.  
 
We will ensure this timing, by following the symptoms and inflammation of feces continuously through a 
web program, to provide treatment as soon as there is a progress in the disease activity. 
 
Usefulness of the experiment and number of participants 
By participating in the experiment, your child will in future help other children and adolescents with 
inflammatory bowel disease. We hope to get 25 participants in the trial. 
 
Risks, side effects and disadvantages 
Overall, there is no risk associated with participation in the project. There are no risks associated with 
abduction tests, nor are there any risks associated with blood sampling. Personal information will be stored 
on a secure computer that is subject to the Data Inspectorate's rules and complies with the applicable law 
on the processing of personal data. Users of the system, patients or patient's doctor (if the doctor has 
patient acceptance) may at any time request their personal data deleted. 
 
Exclusion and discontinuation of tests 
It is voluntary to participate in the trial. You may, at any time and without giving a reason, withdraw your 
consent for your child's participation in the project. It will not affect your child's further treatment. 
 
The website has been tested on adult patients without any security issues when using the disease 
monitoring website. Therefore, we do not expect circumstances to arise that can lead to the interruption of 
the experiment. If the project should cause harmful effects, the project will be completed and you will be 
informed accordingly. 
 
Consent for your child's participation in the trial involves giving you access to the relevant authorities as 
part of their control of the trial, obtaining necessary information about the health status of the subject. The 
authorities are subject to secrecy. 
 
Web Program 
The web program consists of a personal website and each participant is assigned a personal login and 
password. On the website, your son/daughter must record symptoms and answers from the fecal samples 
are recorded from the laboratory. 
 
The website is structured as a three-color scheme: red, yellow green, - as a traffic light corresponding to 
severe, medium or mild disease activity. The computer calculates how active your child's disease is by 
adding symptoms and fecal tests and the disease activity is depicted in the traffic light scheme. If your 
son/daughters disease activity is in yellow or red zone, it means he/she needs treatment. 

ClinicalTrials.gov Identifier: NCT01860651 
 
Plan of the project and what should your child do: 
The trial will continue for 2 years. You will initially be invited to a meeting with a project doctor who will 
teach your son/daughter in the use of the website and explain what symptoms you should be aware of. 
After your son/daughter has learned to use the website, the participation starts. 
 
Symptoms and Health: Symptoms and questions about your health should be entered 4 weeks after 
treatment and then once a week until you receive treatment. 
 
Fecal tests: A fecal test for inflammation should be submitted 4 weeks after a treatment, and then once a 
week for the next treatment. An “easy-sampler-set” is provided for use to sample the stool. The set 
includes gloves, plastic pipes and a piece of paper that can be put on the toilet that keeps the stool. After 
the sample has been removed, the paper can be flushed by the toilet. The quantity of the fecal sample 
should size a hazelnut (equivalent to 10 grams.) 
 
SMS reminder: Your son / daughter will receive a text message with a reminder of when he/she has to 
enter symptoms and submit a stool sample. 
 
Treatment: When activity occurs in your child's disease, corresponding to yellow or red area in the traffic 
light, he/she must receive treatment within three days. Therefore, you must contact the department and 
agree on time for treatment when activity occurs in the disease. 
 
Blood tests: Prior to treatment, in relation to intravenous access, blood samples are deprived in the same 
way as usual when your child is to be treated. 18 ml of blood are removed. Blood will be analyzed for 
inflammations markers and effectiveness (concentration and antibodies) of the medication (infliximab). 
 
Health, well-being and hospitalization: 5 weeks after treatment, as well as the day of treatment, a schedule 
regarding your child´s overall health and well-being must be completed. In addition, the number of missed 
school days and whether there have been any extra out patients visitis between each treatment. If there 
have been hospitalizations, a doctor will gather information from your child's journal on when, for how long 
and for what reason, the hospitalization expired. 
 
Only your child, you and the doctor have access to the website. The doctor has access to follow the 
symptoms so that you can contact you if necessary. You can always contact a doctor or other doctor if 
necessary and acute deterioration. 
 
As this is the first time we use the website, we will also ask your son/daughter about how it was to use the 
website and whether it should be changed. Since there are upcoming patients who have the same illness 
and age as your child who needs the website, the answers will be useful for the further development of the 
website. 
 
Smartphones 
The web page is made feasible to smartphones, which allows your child to enter symptoms regardless of 
where he/she is. We want to make it as easy for your child as possible to use the program. 
 
Handling of biological material 
All biological material, i.e. blood and bowel tests will be linked to a participant number, that is, all samples 
will be encoded but can be relegated to the relevant CPR number by project physicians if necessary. When 
data will be analyzed and presented, it is after coded data, why personal information will not appear. 

ClinicalTrials.gov Identifier: NCT01860651 
Blood samples are analyzed immediately as soon as the laboratories receive the samples and material that 
is not used will be destroyed. Excessive feces are stored in a biobank for later scientific research. The 
samples are encoded by participant number so personal information is not displayed. 
 
10 years after end of the study, all data and samples from the project will be destroyed. 
 
However, if you do not want your child to participate in the project, he/she may be destroyed if you wish 
 
Information about economic conditions 
The website is founded on the idea of professor Pia Munkholm, consultant in adult gastrointestinal 
diseases, Herlev Hospital. The project is organized by PhD student Katrine Carlsen with close guidance from 
senior consultant in pediatrics, Vibeke Wewer and consultant Pia Munkholm. Trial manager is not affiliated 
with support providers. 
 
The project is covered by mutual funds and is supported by: European Crohn´s and Colitis Organization, 
Queen Louise´s Hospital Foundation, Tryg Foundation, CALPRO A/S, Tillotts Pharma, Capital Region 
Denmark, Alice and Frimodts Foundation, Ulcerative Colitis and Crohn´s Danish Patient Society, MSD, and 
Promonitor/Orion Diagnostica. 
 
Access to experimental results 
Ongoing results from the project will be presented at the annual family home evening at the IBD Center at 
Hvidovre Hospital, where you are welcome to come and hear about the project. In addition, the results of 
the trial will continuously be printed in international journals, as well as presented at international and 
national congresses. All data from participants will be anonymized, which means that participants in the 
project cannot be identified. The trial will be completed in January 2016, after which data will be analyzed 
and described. 
 
More information 
In addition to this written information, we will also provide you with oral information about the project. 
This, you will be invited to if you are interested in participating. If you would like to know more about the 
experiment, please feel free to contact us at the contact details below. You must sign a permit for your 
child to be part of the project. We need a signature from both mother and father. We also ask you to read 
the last page for "The subject's rights in a health science research."