IBDoc® Canadian User Performance Evaluation
Primary Purpose
Inflammatory Bowel Diseases
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
IBDoc calprotectin test
questionnaire
Sponsored by
About this trial
This is an interventional diagnostic trial for Inflammatory Bowel Diseases focused on measuring Crohn's disease, ulcerative colitis, fecal calprotectin
Eligibility Criteria
Inclusion Criteria:
- Patients > 12 years
- IBD Outpatients from a tertiary gastroenterological health care center willing to participate.
- Patients diagnosed with Ulcerative Colitis (UC) or Crohn's disease (CD), according to classical criteria (laboratory testing and exclusion of other possible causes: complete blood count, comprehensive metabolic panel, serological markers e.g. antineutrophil cytoplasmic antibody (ANCA), inflammatory markers in blood and serum: erythrocyte sedimentation rate, C-reactive protein (CRP); fecal occult blood and fecal calprotectin assays; confirmation by endoscopy, histology of a biopsy)
- At least 30% patients should display active disease. This can be defined by a Harvey-Bradshaw index (HBI) > 5 in CD and a clinical Mayo score > 2 in UC
- Remaining patients in clinical remission or only mildly active disease defined by a HBI<7 in CD and a clinical Mayo score < 3 in UC with a stable medical treatment
- In case of a prescribed endoscopy, the observation period starts >3 days after colonoscopy
- Stable care of a treating physician
- Signed informed consent
Exclusion Criteria:
- Other known pathology or predisposition that may interfere with the ability to perform the measurement procedures or that may influence calprotectin levels such as acute diarrhea or chronic use of non-steroidal anti-inflammatory drugs
- Inability to understand the procedures
- Inability to psychologically handle potential test outcomes
Sites / Locations
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine University of Alberta,
- GIRI (GI Research Institute)
- Hôtel-Dieu de Lévis,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IBD patients
Arm Description
IBD patients performing IBDoc calprotectin test and ease-of-use questionnaires
Outcomes
Primary Outcome Measures
Trueness/ accuracy of patients IBDoc® results
Patients' IBDoc results are compared to reference calprotectin values obtained by laboratory methods
Quantifiable feedback from the enrolled patients about the ease-of-use of the test
Ease-of-use of the test, clearness of test results and comprehensiveness of the instructions for use is assessed in a questionnaire, with 12 statements, scored on a 1-to-5 Likert scale, with one (1) indicating "I strongly disagree" and five (5) "I strongly agree". The mean and standard deviation of scores obtained from all participating patients will be evaluated for each statement.
Quantifiable feedback from healthcare providers
Quantifiable feedback from the healthcare providers about the ability of the patients to correctly perform the IBDoc® assay. Assessment will be made through a questionnaire with five (5) statements, scored on a 1-to-5 Likert scale, with one (1) indicating "I strongly disagree" and five (5) "I strongly agree". The mean and standard deviation of scores obtained from all participating healthcare providers will be evaluated for each statement.
Secondary Outcome Measures
Full Information
NCT ID
NCT03408249
First Posted
January 17, 2018
Last Updated
January 23, 2018
Sponsor
Bühlmann Laboratories AG
1. Study Identification
Unique Protocol Identification Number
NCT03408249
Brief Title
IBDoc® Canadian User Performance Evaluation
Official Title
IBDoc® Canadian User Performance Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
August 22, 2017 (Actual)
Study Completion Date
August 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bühlmann Laboratories AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the IBDoc® user performance evaluation is to demonstrate the ease-of-use of the IBDoc® calprotectin home test to allow patients with inflammatory bowel disease (IBD) to independently and correctly determine calprotectin concentration in their own stool sample. The study is based on Chapter 8 of the International Organization for Standardization (ISO) Standard, ISO 15197:2013 "In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus". The study is a prospective, multicenter study, not blinded for patients, and includes a total of 61 patients.
Detailed Description
The patient will determine the calprotectin concentration in their own stool sample using the IBDoc® assay. For this, the patient will collect a stool sample in a standard collection tube at home. The patients will return to the clinical site with the specimen, where they will receive a standardized IBDoc® training. They will also be given opportunity to perform an IBDoc® practice test using the collected sample. The patients will then perform the full IBDoc® assay using the collected stool sample under the observation of the healthcare provider, who will assess their performance. The final result - the interpretation of the IBDoc® lateral flow assay by the CalApp® smartphone application, to yield a final μg/g calprotectin concentration in stool, will be sent to the health care provider (HCP) via the IBDoc® Web Portal.
The usability of the IBDoc® test will be evaluated according to the following factors:
- Trueness/ accuracy - the patients' ability to obtain correct results will be evaluated by comparing patients' IBDoc® results with reference measurements from the same stool sample using the BÜHLMANN fCAL® ELISA, performed at a laboratory site. For reference measurements the HCP at the clinical site will obtain 3 CALEX® Cap extracts from the patient's stool sample, which will be stored frozen and shipped to the laboratory site.
To exclude bias or inaccuracy that may arise from the analytical performance characteristics of the IBDoc® assay itself, a comparative IBDoc® assay will be performed according to the instructions for use, with the patients' samples in a laboratory. For the comparative IBDoc® measurement the HCP at the clinical site will obtain one CALEX® Valve extract from the patient's stool sample, which will be stored frozen and shipped to the laboratory site.
-IBDoc® Calprotectin test usability, clearness of obtained result, and comprehensiveness of the Instruction for Use will be assessed in the following ways:
Patient's questionnaire
HCP's questionnaire - human factors evaluation
The ability of patients to correctly collect and extract stool samples using the CALEX® Valve device will be analysed as an additional module within the IBDoc® User Performance Evaluation. The CALEX® Valve extracts obtained by the patients as part of the IBDoc® procedure will be stored frozen and shipped to the laboratory site. Calprotectin levels in the patients' CALEX® Valve extracts will be determined with the BÜHLMANN fCAL® ELISA and compared to calprotectin reference values obtained from the same stool samples by the HCP's.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Crohn's disease, ulcerative colitis, fecal calprotectin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBD patients
Arm Type
Experimental
Arm Description
IBD patients performing IBDoc calprotectin test and ease-of-use questionnaires
Intervention Type
Diagnostic Test
Intervention Name(s)
IBDoc calprotectin test
Intervention Description
Patients are asked to perform a single IBDoc calprotectin home test.
Intervention Type
Other
Intervention Name(s)
questionnaire
Intervention Description
Patients evaluate the ease-of-use of the test, clearness of test results and comprehensiveness of the instructions for use through a specific questionnaire implementing Likert scales.
Primary Outcome Measure Information:
Title
Trueness/ accuracy of patients IBDoc® results
Description
Patients' IBDoc results are compared to reference calprotectin values obtained by laboratory methods
Time Frame
24 hours
Title
Quantifiable feedback from the enrolled patients about the ease-of-use of the test
Description
Ease-of-use of the test, clearness of test results and comprehensiveness of the instructions for use is assessed in a questionnaire, with 12 statements, scored on a 1-to-5 Likert scale, with one (1) indicating "I strongly disagree" and five (5) "I strongly agree". The mean and standard deviation of scores obtained from all participating patients will be evaluated for each statement.
Time Frame
24 hours
Title
Quantifiable feedback from healthcare providers
Description
Quantifiable feedback from the healthcare providers about the ability of the patients to correctly perform the IBDoc® assay. Assessment will be made through a questionnaire with five (5) statements, scored on a 1-to-5 Likert scale, with one (1) indicating "I strongly disagree" and five (5) "I strongly agree". The mean and standard deviation of scores obtained from all participating healthcare providers will be evaluated for each statement.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients > 12 years
IBD Outpatients from a tertiary gastroenterological health care center willing to participate.
Patients diagnosed with Ulcerative Colitis (UC) or Crohn's disease (CD), according to classical criteria (laboratory testing and exclusion of other possible causes: complete blood count, comprehensive metabolic panel, serological markers e.g. antineutrophil cytoplasmic antibody (ANCA), inflammatory markers in blood and serum: erythrocyte sedimentation rate, C-reactive protein (CRP); fecal occult blood and fecal calprotectin assays; confirmation by endoscopy, histology of a biopsy)
At least 30% patients should display active disease. This can be defined by a Harvey-Bradshaw index (HBI) > 5 in CD and a clinical Mayo score > 2 in UC
Remaining patients in clinical remission or only mildly active disease defined by a HBI<7 in CD and a clinical Mayo score < 3 in UC with a stable medical treatment
In case of a prescribed endoscopy, the observation period starts >3 days after colonoscopy
Stable care of a treating physician
Signed informed consent
Exclusion Criteria:
Other known pathology or predisposition that may interfere with the ability to perform the measurement procedures or that may influence calprotectin levels such as acute diarrhea or chronic use of non-steroidal anti-inflammatory drugs
Inability to understand the procedures
Inability to psychologically handle potential test outcomes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Rosenfeld, MD
Organizational Affiliation
GIRI (GI Research Institute), Vancouver, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Gastroenterology, Department of Medicine, Faculty of Medicine University of Alberta,
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R7
Country
Canada
Facility Name
GIRI (GI Research Institute)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Hôtel-Dieu de Lévis,
City
Lévis
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
30535387
Citation
Moore AC, Huang VW, Bourdages R, Fedorak RN, Reinhard C, Leung Y, Bressler B, Rosenfeld G. IBDoc Canadian User Performance Evaluation. Inflamm Bowel Dis. 2019 May 4;25(6):1107-1114. doi: 10.1093/ibd/izy357.
Results Reference
derived
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IBDoc® Canadian User Performance Evaluation
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