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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-monitoring | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Prospective, each third month, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The first event during participation (2 years). (events were prospecitvely registered) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrine Carlsen, MD | Department of Pediatrics, Hvidovre Hospital | Principal Investigator |
| Vibeke Wewer, MD, PhD | Department of Pediatrics, Hvidovre Hospital | Study Chair |
| Pia Munkholm, Professor | Department of Gastroenterology, Herlev Hospital | Study Chair |
| Christian Jakobsen, MD, PhD | Department of Pediatrics, Hvidovre Hospital | Study Chair |
| Lene Riis, MD, PhD | Department of Pathology, Herlev Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28169974 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Web-monitoring | There is two arms for intervention: 1) Patients in treatment with medicine administrated at home and 2) patients in treatment with biologicals. Web-monitoring: 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. |
| FG001 | Control | Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year. Patients in treatment with biologicals: routine treatment algorithm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Web-monitoring | There is two arms for intervention: Study 1) Patients in treatment with medicine administrated at home and Study 2) patients in treatment with biologicals. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of participants is only from study 1) Patients in treatment with medicine adminstered at home (participant in the web-group: 27; participant in the control-group: 26) | Posted | Mean | 95% Confidence Interval | units on a scale | Prospective, each third month, up to 2 years |
|
2 ½ year
Adverse Event that occured was allergic reactions during Infliximab infusions.
Infusion related reactions was not collected in the biological control group. The control group was collected only to compare blood trough levels of IFX antibodies, IFX concentration, and treatment intervals. Therefore the total number of participants in the Adverse event tables representing participants in study 2 (patients in treatment with biologicals), only represents participants in the web-group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Web-monitoring | There is two arms for intervention: 1) Patients in treatment with medicine administrated at home and 2) patients in treatment with biologicals. Web-monitoring: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious adverse event | Immune system disorders | Systematic Assessment | Data represents study 1. Description: events that would result in death, life-threatening events, prolongation of hospitalization or required intervention to prevent permanent impairment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion-related allergic reactions | Immune system disorders | Systematic Assessment | Infliximab infusion-related allergic reactions was only collected in the web group in study 2 (Patients in treatment with biologicals). Data regarding infusion-related allergic reactions was not collected in the control group in study 2. |
The main limitation is the relatively few participants that were all sourced from one center.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katrine Carlsen | Hvidovre University Hospital | 26180513 | 0045 | katrinec@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 24, 2013 | Nov 4, 2017 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Surgery | Need for surgery | The first event during participation (2 years). (events were prospecitvely registered) |
| Absence From School | Number of days absence from school | 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 | 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. | Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years |
Study 1) Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.
Study 2) Patients in treatment with biologicals: retrospective routine treatment algorithm
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | The first event during participation (2 years). (events were prospecitvely registered) |
|
|
|
| Secondary | Surgery | Need for surgery | In this analysis both participants from study 1 (web 27, control 26) and 2 (web 29, control 21) are represented. No surgeries were performed, and therefore there is no mean and SD | Posted | Mean | Standard Deviation | Surgeries | The first event during participation (2 years). (events were prospecitvely registered) |
|
|
|
| Secondary | Absence From School | Number of days absence from school | Posted | Mean | Standard Error | days | Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years |
|
|
|
| Secondary | Contact to the Hospital | Need for outpatient visits | Posted | Median | Inter-Quartile Range | visits | Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years |
|
|
|
| Secondary | Number of Weeks Between Treatment | Date of IFX infusions were prospectively registered from both the eHealth and the control groups. | Posted | Mean | Standard Deviation | weeks | Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years |
|
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|
| 0 |
| 56 |
| 0 |
| 56 |
| 3 |
| 29 |
| EG001 | Control | Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year. Patients in treatment with biologicals: retrospective routine treatment algorithm | 0 | 47 | 0 | 26 | 0 | 0 |
|
| serious adverse events | Immune system disorders | Systematic Assessment | Data represents study 2. Serious event-data was not collected in the control group. Description: events that would result in death, life-threatening events, prolongation of hospitalization or required intervention to prevent permanent impairment. |
|
|
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| D003092 | Colitis |
| D003108 | Colonic Diseases |