Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients ?
Primary Purpose
Inflammatory Bowel Diseases
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
At Home Screening procedure On demand
At Home Screening procedure every 3 months
Sponsored by
About this trial
This is an interventional supportive care trial for Inflammatory Bowel Diseases focused on measuring IBD, Telemedicine, At-home monitoring, Disease activity, fecal calprotectin, Total inflammation burden, 11 years follow up
Eligibility Criteria
Inclusion Criteria:
- IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey & Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16). IBD patients who can read, speak and understand Danish. IBD patients that can take advantage of the Internet and wireless network.
Exclusion Criteria:
- IBD patients with severe disease activity HB > 16 SCCAI ≥ 5. IBD patients with social, medical or psychological issues of a more complex character. IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.IBD patients who cannot attend due language barrier or cognitive disorder.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Every 3 months
On demand
Arm Description
screening every 3rd month: (home monitoring: FC and DA)
screening On demand: (home monitoring: FC and DA)
Outcomes
Primary Outcome Measures
colectomies
Number of colectomies
resections
Number of resections
mortalities
Number of deaths
cancer
cancer rates
Secondary Outcome Measures
Hospitalizations
number of hospitalizations and days
FC (Fecal Calprotectin) area under the curve (AUC)
Both AUC total, but also as a red >600 mg/kg, yellow (200-600 mg/kg) and green (below 200mg/kg ) AUC will be performed from the individualized curves
Simple clinical colitis activity index (SCCAI): area under the curve (AUC)
Both AUC total, but also as a red >5, yellow (2-4) and green (< 2 ) AUC will be performed from the individualized curves
Harvey-Bradshaw index (HBI): area under the curve (AUC)
Both AUC total, but also as a red >16 , yellow (6-16) and green (≤5) AUC will be performed from the individualized curves
Disease course, Copenhagen IBD Disease course Type
Based on epidemiology four figures have been developed to describe disease-course of IBD. These figures have been used in a retrospective study (Maagaard et al. 2016) to measure change in Disease course.The four figures depicting different types of disease courses is described as follows:
Mild IBD with indolent course
Mild IBD with aggressive course
Chronic IBD with continuous course
Chronic IBD with intermittent course The patients have to choose one figure representing their disease course type the best at inclusion and 11 years later
Full Information
NCT ID
NCT03038984
First Posted
January 24, 2017
Last Updated
April 14, 2022
Sponsor
Nordsjaellands Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03038984
Brief Title
Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients ?
Official Title
Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients Tightly on Demand or Every 3 Months by Fecal Calprotectin and Disease Activity?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nordsjaellands Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555. The purpose of this study is to determine if the IBD patients doing home monitoring (screening themselves on demand (OD) or every 3 months) have relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD patients are self-monitoring by web apps consisting of a short disease activity questionnaire (DA) and fecal calprotectin (FC) on any smart phone.
Detailed Description
This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555. Among 2.500 IBD patients the investigators have consecutively from the Gastroenterology out-patient clinic at North Zealand University Hospital recruited in total 120 in the study.
At the out-patient consultation IBD patients has been informed about the project and the IBD eHealth nurse has ensured that no exclusion criteria was met by the patients.
Inclusion criteria:
IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey & Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16) IBD patients who can read, speak and understand Danish. IBD patients that can take advantage of the Internet and wireless network. 18 years or older.
Exclusion criteria:
IBD patients with severe disease activity HB > 16 SCCAI ≥ 5 IBD patients with social, medical or psychological issues of a more complex character. IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.IBD patients who cannot attend due language barrier or cognitive disorder. Age less than 18.
When the patient has agreed to participate in the study, randomized to either OD or 3. Months (This has been done ClinicalTrials.gov ID: NCT02492555)
Patients log in to www.noh.constant-care.dk at least once every 3rd months throughout the project period of 11 years in total (2015-2026). When the patient log in to the telemedicine platform the following scorings must be filled out:
- Disease activity (DA), respectively SCCAI or HBI.
- Quality of life assessment, s-IBDQ
- FACIT (Fatigue score)
- MARS ( Medical Adherence Rating Scale)
- FC, fecal calprotectin mg / kg measured by the patient's own SMART phone, rapid home test.
If the patients prefer to send the fecal samples for test, it will be analyzed in the ehealth gastro lab. at the hospital with a SMART phone as well.
The results of the scoring systems will appear to the health care professionals and patients in a traffic light manner (red, yellow and green).
If the patient experiences a recurrence of the disease, it moves from green to either yellow or red area in the traffic graph, and patient will further be instructed to contact Gastro medical clinic project nurse for an early consultation and decision on further treatment initiative. This will also be indicated at the patient's website. If alarm symptoms occurs patients are instructed to contact the project nurse. Thus patients are treated in accordance to national and international guideline. By screening of the inflammation burden (web algorithm), the decision is moving forward.
Patients logging in on demand, indicate disease activity, quality of life and FC at the start, and subsequently when needed and at the end of the study (after 11 years from inclusion).
At relapse, disease activity score and FC is settled and repeated no later than 7 days here after. When the patient has reached remission (green) a new DA and FC test should be performed to verify the remission.
The purpose of this study is to determine if the IBD patients doing home monitoring have relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of web monitoring. Relative reduced rates of colectomies etc. means - relative to standard care but also if there is a difference between the two web screening procedures on these endpoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
IBD, Telemedicine, At-home monitoring, Disease activity, fecal calprotectin, Total inflammation burden, 11 years follow up
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
120 IBD patients has been randomized to screen for disease activity and FC either OD or every 3 months. 60 patients in each group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Every 3 months
Arm Type
Experimental
Arm Description
screening every 3rd month: (home monitoring: FC and DA)
Arm Title
On demand
Arm Type
Active Comparator
Arm Description
screening On demand: (home monitoring: FC and DA)
Intervention Type
Behavioral
Intervention Name(s)
At Home Screening procedure On demand
Intervention Description
Home monitoring is a supportive treatment. Patients are randomized to screen themselves on demand
Intervention Type
Behavioral
Intervention Name(s)
At Home Screening procedure every 3 months
Intervention Description
Home monitoring is a supportive treatment. Patients are randomized to screen themselves every 3 months
Primary Outcome Measure Information:
Title
colectomies
Description
Number of colectomies
Time Frame
11 years
Title
resections
Description
Number of resections
Time Frame
11 years
Title
mortalities
Description
Number of deaths
Time Frame
11 years
Title
cancer
Description
cancer rates
Time Frame
11 years
Secondary Outcome Measure Information:
Title
Hospitalizations
Description
number of hospitalizations and days
Time Frame
11 years
Title
FC (Fecal Calprotectin) area under the curve (AUC)
Description
Both AUC total, but also as a red >600 mg/kg, yellow (200-600 mg/kg) and green (below 200mg/kg ) AUC will be performed from the individualized curves
Time Frame
11 years
Title
Simple clinical colitis activity index (SCCAI): area under the curve (AUC)
Description
Both AUC total, but also as a red >5, yellow (2-4) and green (< 2 ) AUC will be performed from the individualized curves
Time Frame
11 years
Title
Harvey-Bradshaw index (HBI): area under the curve (AUC)
Description
Both AUC total, but also as a red >16 , yellow (6-16) and green (≤5) AUC will be performed from the individualized curves
Time Frame
11 years
Title
Disease course, Copenhagen IBD Disease course Type
Description
Based on epidemiology four figures have been developed to describe disease-course of IBD. These figures have been used in a retrospective study (Maagaard et al. 2016) to measure change in Disease course.The four figures depicting different types of disease courses is described as follows:
Mild IBD with indolent course
Mild IBD with aggressive course
Chronic IBD with continuous course
Chronic IBD with intermittent course The patients have to choose one figure representing their disease course type the best at inclusion and 11 years later
Time Frame
11 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey & Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16). IBD patients who can read, speak and understand Danish. IBD patients that can take advantage of the Internet and wireless network.
Exclusion Criteria:
IBD patients with severe disease activity HB > 16 SCCAI ≥ 5. IBD patients with social, medical or psychological issues of a more complex character. IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.IBD patients who cannot attend due language barrier or cognitive disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Munkholm, Professor
Organizational Affiliation
North Zealand University Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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