IBDoc® Canadian User Performance Evaluation

NCT03408249 | Completed

• 1 other identifier: IBDoc_UserPerfomance006
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 3

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Crohn's disease, ulcerative colitis, fecal calprotectin

Outcome Measures

Primary Outcomes (3)

• Trueness/ accuracy of patients IBDoc® results

  Patients' IBDoc results are compared to reference calprotectin values obtained by laboratory methods

  24 hours

• 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.

  24 hours

• 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.

  24 hours

Study Arms (1)

IBD patients

EXPERIMENTAL

IBD patients performing IBDoc calprotectin test and ease-of-use questionnaires

Diagnostic Test: IBDoc calprotectin test; Other: questionnaire

Interventions

IBDoc calprotectin test DIAGNOSTIC_TEST

Patients are asked to perform a single IBDoc calprotectin home test.

IBD patients

questionnaire OTHER

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.

IBD patients

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 12 years
• IBD Outpatients from a tertiary gastroenterological health care center willing to participate.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bühlmann Laboratories AG: lead

Study Sites (3)

Division of Gastroenterology, Department of Medicine, Faculty of Medicine University of Alberta,

Edmonton, Alberta, T6G 2R7, Canada

Location

GIRI (GI Research Institute)

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Hôtel-Dieu de Lévis,

Lévis, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 30535387 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Greg Rosenfeld, MD

  GIRI (GI Research Institute), Vancouver, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 23, 2018
• Study Start: May 5, 2017
• Primary Completion: August 22, 2017
• Study Completion: August 22, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

CA (3)