Trial Outcomes & Findings for Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease (NCT NCT01860651)

Last Updated: 2019-03-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

103 participants

Primary outcome timeframe

Prospective, each third month, up to 2 years

Results posted on

2019-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Control Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year. Patients in treatment with biologicals: routine treatment algorithm
Overall Study STARTED	56	47
Overall Study COMPLETED	31	39
Overall Study NOT COMPLETED	25	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Web-monitoring n=56 Participants There is two arms for intervention: Study 1) Patients in treatment with medicine administrated at home and Study 2) patients in treatment with biologicals.	Control n=47 Participants 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	Total n=103 Participants Total of all reporting groups
Age, Categorical <=18 years	56 Participants n=5 Participants	47 Participants n=7 Participants	103 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	15.1 years STANDARD_DEVIATION 1.82 • n=5 Participants	14.7 years STANDARD_DEVIATION 2.11 • n=7 Participants	14.9 years STANDARD_DEVIATION 0.2 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	22 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	56 Participants n=5 Participants	47 Participants n=7 Participants	103 Participants n=5 Participants
Region of Enrollment Denmark	56 participants n=5 Participants	47 participants n=7 Participants	103 participants n=5 Participants

PRIMARY outcome

Timeframe: Prospective, each third month, up to 2 years

Population: 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)

Outcome measures

Outcome measures
Measure	Web-monitoring n=27 Participants Patients in treatment with medicine administrated at home 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.	Control n=26 Participants Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.
Medical Adherence	23.3 units on a scale Interval 22.9 to 23.6	23.3 units on a scale Interval 22.9 to 23.7

SECONDARY outcome

Timeframe: The first event during participation (2 years). (events were prospecitvely registered)

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.

Outcome measures

Outcome measures
Measure	Web-monitoring n=26 Participants Patients in treatment with medicine administrated at home 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.	Control n=27 Participants Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.
Number of Participants With Step up in Medical Intensity	10 Participants	12 Participants

SECONDARY outcome

Timeframe: The first event during participation (2 years). (events were prospecitvely registered)

Population: 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

Need for surgery

Outcome measures

Outcome measures
Measure	Web-monitoring n=56 Participants Patients in treatment with medicine administrated at home 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.	Control n=47 Participants Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.
Surgery	0 Surgeries Standard Deviation 0	0 Surgeries Standard Deviation 0

SECONDARY outcome

Timeframe: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years

Number of days absence from school

Outcome measures

Outcome measures
Measure	Web-monitoring n=27 Participants Patients in treatment with medicine administrated at home 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.	Control n=26 Participants Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.
Absence From School	1.6 days Standard Error 0.5	16.5 days Standard Error 4.4

SECONDARY outcome

Timeframe: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years

Need for outpatient visits

Outcome measures

Outcome measures
Measure	Web-monitoring n=27 Participants Patients in treatment with medicine administrated at home 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.	Control n=26 Participants Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.
Contact to the Hospital	2 visits Interval 2.0 to 3.0	8 visits Interval 4.0 to 9.0

SECONDARY outcome

Timeframe: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years

Date of IFX infusions were prospectively registered from both the eHealth and the control groups.

Outcome measures

Outcome measures
Measure	Web-monitoring n=29 Participants Patients in treatment with medicine administrated at home 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.	Control n=21 Participants Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.
Number of Weeks Between Treatment	9.5 weeks Standard Deviation 2.3	6.9 weeks Standard Deviation 1.4

Adverse Events

Web-monitoring

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Web-monitoring n=29 participants at risk；n=56 participants at risk 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.	Control n=26 participants at risk Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year. Patients in treatment with biologicals: retrospective routine treatment algorithm
Immune system disorders Serious adverse event	0.00% 0/27 • 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.	0.00% 0/26 • 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.
Immune system disorders serious adverse events	0.00% 0/29 • 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.	— 0/0 • 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.

Other adverse events

Other adverse events
Measure	Web-monitoring n=29 participants at risk；n=56 participants at risk 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.	Control n=26 participants at risk Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year. Patients in treatment with biologicals: retrospective routine treatment algorithm
Immune system disorders Infusion-related allergic reactions	10.3% 3/29 • Number of events 3 • 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.	— 0/0 • 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.

Additional Information

Dr. Katrine Carlsen

Hvidovre University Hospital

Phone: 26180513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place