Inflammatory Bowel DiseaseNCT01860651
Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease
A study testing Web-monitoring in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The investigators hypothesize that E-health - web based monitoring of disease and treatment - in young patients with chronic inflammatory disease (IBD) can improve the disease course and quality of life. Adherence (to take the prescribed medicine) is difficult for young patients. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohn´s Disease
- What is being tested?
- Web-monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- IBD diagnosis according to the Copenhagen and Porto criteria
- Aged between 10-17 years
- Fluent in Danish
- Access to the internet
- Patients in treatment with infliximab must have completed the induction period (i.e. minimum six week after start-up of treatment).
Who cannot join
- Insufficient Danish language skills
- Lack of intellectual capacity
- Growth retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Empowerment: Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease for Better Quality of Treatment
The investigators hypothesize that E-health - web based monitoring of disease and treatment - in young patients with chronic inflammatory disease (IBD) can improve the disease course and quality of life.
Adherence (to take the prescribed medicine) is difficult for young patients. In this E-health project the investigators seek to improve young patients (10-17 years) responsibility for treatment, to empower them and thereby enhance the adherence in order to achieve a more quiet disease course. Through the e-Health program and web-app the disease activity will be presented to the young patient via a simple traffic light chart and the patient will be guided to: continue the prescribed medication, call the physician or visit the out-patient clinic. In future the concept is believed also to be applicable for young patients with other chronic diseases.
Read the detailed description
IBD's natural history is characterized by relapses (e.g. rectal bleeding, diarrhoea, abdominal pain, faecal urgency, fistula and anal abscess) and remissions. In children and adolescents the disease has a more aggressive course as compared with adults, causing a deterioration in the quality of life. During puberty patients are in an especially vulnerable period of their lives and there is a high risk for developing social disabilities due to the disease. Furthermore, IBD can lead to many days of absence from school and patients are at risk of not being able to maintain their education.
Patients are treated medically when the disease is active, but also in quiet phases too in order to maintain remission. It is therefore crucial for success that patients receive insight into the disease and understand the importance of following the recommended maintenance treatment. Despite being aware of an increased risk of acute hospitalization and surgery, it is difficult for both adult and pediatric patients to follow the continuous medication (adherence). It is known that up to 50% of young patients fail to take their medication as directed.
Previous studies have used E-health in the treatment of IBD patient. In M. Elkjaer et al. 2010 study on 300 patients with mild-to-moderate UC, E-health treatment resulted in shorter 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. In another study, Pedersen et al. 2012, on 27 patients with CD and examining biological treatment, E-Health was able to optimize the timing of infliximab treatment in CD patients. The E-Health solution was safe to use and patients showed high adherence to the program (86%). To the investigators knowledge no study has previously used E-health treatment in children and adolescents with IBD. It is, however, the investigators belief that this treatment concept would be readily taken up such patients, for whom web communication, at least in Denmark, is already a well-integrated part of their daily lives.
The current study consists of two projects: Project A: Patients in treatment with medicine administrated at home. Project B: Patients in treatment with biological infusions
Project A: Patients in treatment with medicine administrated at home are monitored, according to current international guidelines, with outpatient visits every third month. Patients participating in the current project will be randomly split into two groups and followed for two years. E-health group: Web-monitoring with an annual visit to the IBD center. Control group: Routine outpatient controls, four times a year.
Project B: According to current guidelines, patients receiving treatment with biologicals visit the outpatient clinic approximately every eighth week and treatment is given intravenously. During the E-health intervention, symptoms and fecal calprotectin are monitored closely through the web-program, and treatment will be initiated by symptoms and elevated FC. In this way the timing of treatment with biologicals can be optimized and infusions delayed with a maximum treatment-free period of 12 weeks, or earlier than 8 weeks if necessary.
- Being tested
- Web-monitoring
- Keywords
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohn´s Disease, Children, Adolescence, E-health web-monitoring, Adherence, Disease activity, Fecal Calprotectin
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-monitoringBehavioural
During the E-health intervention, symptoms and FC are monitored closely through the web-program and treatment will be initiated by symptoms and elevated FC.
| Study group | Role | What they receive |
|---|---|---|
| Web-monitoring | Active comparator | There is two arms for intervention:
1) Patients in treatment with medicine administrated at home and 2) patients in treatment with biologicals. Receives: Behavioral: Web-monitoring |
| Control | No intervention | Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year. Patients in treatment with biologicals: retrospective routine treatment algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Adherence
Participants (group 1, medication adm. at home): Medicine Adherence Report Scale (MARS): range 5-25 points. Higher scores mean a better outcome. In the below Outcome Measure Data Table the mean data for each group (web and control) summarized from the whole study periode are presented.
Measured: Prospective, each third month, up to 2 years
Secondary outcomes (5)
Number of Participants With Step up in Medical Intensity
Time to frist step-up in treatment intensity (escalating dose or change/addition of a more potent drug) were obtained from the patient's medical record during the study period, as a proxy of progression in disease activity.
Time to step up was analysed via Kaplan Meier survival analysis.
Measured: The first event during participation (2 years). (events were prospecitvely registered)
Surgery
Need for surgery
Measured: The first event during participation (2 years). (events were prospecitvely registered)
Absence From School
Number of days absence from school
Measured: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Contact to the Hospital
Need for outpatient visits
Measured: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Number of Weeks Between Treatment
Date of IFX infusions were prospectively registered from both the eHealth and the control groups.
Measured: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Katrine Carlsen, MD, Hvidovre University Hospital
- Investigators
- Katrine Carlsen, MD, Principal investigator, Department of Pediatrics, Hvidovre HospitalVibeke Wewer, MD, PhD, Study chair, Department of Pediatrics, Hvidovre HospitalPia Munkholm, Professor, Study chair, Department of Gastroenterology, Herlev HospitalChristian Jakobsen, MD, PhD, Study chair, Department of Pediatrics, Hvidovre HospitalLene Riis, MD, PhD, Study chair, Department of Pathology, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860651
- Sponsor's protocol ID
- YOUNG-WEB
- Status last verified
- Aug 2018
- First submitted
- 20 May 2013
- Last updated
- 1 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Carlsen K, Jakobsen C, Kallemose T, Paerregaard A, Riis LB, Munkholm P, Wewer V. F-calprotectin and Blood Markers Correlate to Quality of Life in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2017 Nov;65(5):539-545. doi: 10.1097/MPG.0000000000001540.
PubMed 28169974
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Empowerment: Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease for Better Quality of Treatment
- ClinicalTrials.gov ID
- NCT01860651
- Acronym / sponsor ID
- YOUNG-WEB
- Keywords
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohn´s Disease, Children, Adolescence, E-health web-monitoring, Adherence, Disease activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Sep 2013
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that E-health - web based monitoring of disease and treatment - in young patients with chronic inflammatory disease (IBD) can improve the disease course and quality of life.
Adherence (to take the prescribed medicine) is difficult for young patients. In this E-health project the investigators seek to improve young patients (10-17 years) responsibility for treatment, to empower them and thereby enhance the adherence in order to achieve a more quiet disease course. Through the e-Health program and web-app the disease activity will be presented to the young patient via a simple traffic light chart and the patient will be guided to: continue the prescribed medication, call the physician or visit the out-patient clinic. In future the concept is believed also to be applicable for young patients with other chronic diseases.
Detailed description
IBD's natural history is characterized by relapses (e.g. rectal bleeding, diarrhoea, abdominal pain, faecal urgency, fistula and anal abscess) and remissions. In children and adolescents the disease has a more aggressive course as compared with adults, causing a deterioration in the quality of life. During puberty patients are in an especially vulnerable period of their lives and there is a high risk for developing social disabilities due to the disease. Furthermore, IBD can lead to many days of absence from school and patients are at risk of not being able to maintain their education.
Patients are treated medically when the disease is active, but also in quiet phases too in order to maintain remission. It is therefore crucial for success that patients receive insight into the disease and understand the importance of following the recommended maintenance treatment. Despite being aware of an increased risk of acute hospitalization and surgery, it is difficult for both adult and pediatric patients to follow the continuous medication (adherence). It is known that up to 50% of young patients fail to take their medication as directed.
Previous studies have used E-health in the treatment of IBD patient. In M. Elkjaer et al. 2010 study on 300 patients with mild-to-moderate UC, E-health treatment resulted in shorter 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. In another study, Pedersen et al. 2012, on 27 patients with CD and examining biological treatment, E-Health was able to optimize the timing of infliximab treatment in CD patients. The E-Health solution was safe to use and patients showed high adherence to the program (86%). To the investigators knowledge no study has previously used E-health treatment in children and adolescents with IBD. It is, however, the investigators belief that this treatment concept would be readily taken up such patients, for whom web communication, at least in Denmark, is already a well-integrated part of their daily lives.
The current study consists of two projects: Project A: Patients in treatment with medicine administrated at home. Project B: Patients in treatment with biological infusions
Project A: Patients in treatment with medicine administrated at home are monitored, according to current international guidelines, with outpatient visits every third month. Patients participating in the current project will be randomly split into two groups and followed for two years. E-health group: Web-monitoring with an annual visit to the IBD center. Control group: Routine outpatient controls, four times a year.
Project B: According to current guidelines, patients receiving treatment with biologicals visit the outpatient clinic approximately every eighth week and treatment is given intravenously. During the E-health intervention, symptoms and fecal calprotectin are monitored closely through the web-program, and treatment will be initiated by symptoms and elevated FC. In this way the timing of treatment with biologicals can be optimized and infusions delayed with a maximum treatment-free period of 12 weeks, or earlier than 8 weeks if necessary.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-monitoring | Active comparator | Behavioral: Web-monitoringThere is two arms for intervention: 1) Patients in treatment with medicine administrated at home and 2) patients in treatment with biologicals. |
| Control | No intervention | –Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year. Patients in treatment with biologicals: retrospective routine treatment algorithm |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- IBD diagnosis according to the Copenhagen and Porto criteria
- Aged between 10-17 years
- Fluent in Danish
- Access to the internet
- Patients in treatment with infliximab must have completed the induction period (i.e. minimum six week after start-up of treatment).
Key exclusion criteria (3 listed)
- Insufficient Danish language skills
- Lack of intellectual capacity
- Growth retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-monitoringDuring the E-health intervention, symptoms and FC are monitored closely through the web-program and treatment will be initiated by symptoms and elevated FC. | Behavioural | Web-monitoring |
Primary outcome
Medical Adherence
Time frame: Prospective, each third month, up to 2 years
Participants (group 1, medication adm. at home): Medicine Adherence Report Scale (MARS): range 5-25 points. Higher scores mean a better outcome. In the below Outcome Measure Data Table the mean data for each group (web and control) summarized from the whole study periode are presented.
5 secondary outcomes
Number of Participants With Step up in Medical Intensity
Time frame: The first event during participation (2 years). (events were prospecitvely registered)
Surgery
Time frame: The first event during participation (2 years). (events were prospecitvely registered)
Absence From School
Time frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Contact to the Hospital
Time frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Number of Weeks Between Treatment
Time frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28169974Carlsen K, Jakobsen C, Kallemose T, Paerregaard A, Riis LB, Munkholm P, Wewer V. F-calprotectin and Blood Markers Correlate to Quality of Life in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2017 Nov;65(5):539-545. doi: 10.1097/MPG.0000000000001540.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrine Carlsen, MD principal investigator
Department of Pediatrics, Hvidovre Hospital
Vibeke Wewer, MD, PhD study chair
Department of Pediatrics, Hvidovre Hospital
Pia Munkholm, Professor study chair
Department of Gastroenterology, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-monitoring in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Adherence (time frame: Prospective, each third month, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01860651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.