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The CalproSmartNOR Study - a New Clinical Tool for Monitoring Patients With Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT03486158
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Collaborators:
Alesund Hospital
Calpro AS
Information provided by (Responsible Party):
Helse Møre og Romsdal HF

Brief Summary:
The aim of this study is to prove that getting immediate calprotectin test results on the patients smartphone, will both stimulate patients with inflammatory bowel disease (IBD) to closer follow up of their disease, and that immediate automatic e-mails to a IBD-nurse will lead to earlier decision-making on further treatment and follow-up by health personnel (optimized medication, endoscopy etc).

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Device: CalproSmart™ system Not Applicable

Detailed Description:

There has been a shift in the therapeutic approach for inflammatory bowel disease (IBD) from symptom-tailored towards inflammation-targeted treatments. Mucosal healing, although not well-defined in past literature, is an objective marker of improvement as well as of favorable prognosis, not only in trials but also in routine clinical practice. However, utilization of frequent endoscopic procedures to assess mucosal healing would be a burden to patients and the stretched endoscopic services in the national health services. A non-invasive marker would give the opportunity to patients and physicians to titrate treatment to inflammatory activity with the aspiration to change the course of the disease.

Calprotectin (FCALP) is a calcium-binding protein abundant in the cytoplasm of neutrophils and macrophages that can be measured in feces reliably. Samples can be transported or stored at room temperature for at least 3 days. FCALP correlates well with histological and endoscopic disease activity in ulcerative colitis and radiology in Crohn's disease.

More importantly calprotectin predicts clinical relapse, outperforming other common non-invasive markers of inflammation (CRP, ESR), and it may also outperform endoscopy in predicting short and long term relapse.

Patients are currently required to provide a stool sample in a universal (non-specialized) container, which usually is processed in a central laboratory. The container is a small plastic cylinder secured with a screw top which has a longitudinal scoop attached to its inner surface. In order to collect the sample, the patients usually put some toilet paper in the toilet and after defecating use the scoop to collect the fecal sample. Then the container is brought to hospital in person and is processed by the laboratory staff. This is a laborious process, as a certain quantity of fecal material has to be manually extracted from each individual sample using a separate kit prior to the measurement, which is performed using an ELISA kit.

In relation to eHealth telemedicine's increasing importance as an aid to therapeutic approaches for IBD patients, the need for an accurate and user-friendly home test for measuring fecal calprotectin concentration has emerged. New technology has improved the collection device, and simplified the collection process by providing a paper sampler device placed over the toilet bowel, making the sampling both easier and cleaner. A preferred system should easily been able to convert the sample into an extract, measure the calprotectin concentration with a rapid-test read by a smartphone app, to produce an instant result for the patient at home which also concomitantly and securely should be sent via a portal to the treating clinician.

The CalproSmart™ system is a Home test kit for measurement of calprotectin in fecal samples, and a new clinical tool for monitoring patients with inflammatory bowel disease. The system consists of five components and a Smartphone- application; A) A sampler and nitrile gloves for collecting stool samples B) A prefilled extraction device to collect stool sample C) A lateral-flow rapid test D) A support frame with a design that enables measurement of calprotectin level of rapid test through a specially developed Smartphone application.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optimalization of Disease Control and Quality of Life in Inflammatory Bowel Disease Using e-Health Measurements Via a Smart Phone Application; CalproSmart
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: CalproSmart application
In addition to regular outpatient clinic visits and a routine CalproSmart test every 3 months, patients are instructed to obtain fecal samples if they experience symptoms suspect of recurrent IBD and to perform home analysis with CalproSmart™ system test kit
Device: CalproSmart™ system
Home test kit for measurement of calprotectin in fecal samples. A new clinical tool for monitoring patients with inflammatory bowel disease, enabling measurement of calprotectin level of rapid test through a specially developed Smartphone application

No Intervention: Standard follow-up
in addition to regular outpatient clinic visits and a routine calprotectin test in the same week as the visit date, patients bring home an F-calpro tube and envelope and are instructed to obtain fecal samples and send these to local lab if they experience symptoms suspect of recurrent IBD



Primary Outcome Measures :
  1. remission rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. time to disease flare for patients in remission at baseline visit [ Time Frame: 1 year ]
  2. time to remission for patients with mild to moderate disease activity in the course of the study [ Time Frame: 1 year ]
  3. Quality of life [ Time Frame: 1 year ]
    assessed by IBD-Q questionnaire (Norwegian version)

  4. number of hospitalizations [ Time Frame: 1 year ]
  5. number of outpatient clinic contacts [ Time Frame: 1 year ]
  6. work presenteeism/absenteeism [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ulcerative colitis and Crohns disease diagnosis that fulfil the international Copenhagen diagnostic criteria for inflammatory bowel diseases (IBD)
  • Remission, mild or moderate disease activity defined as 6-point Mayo Score <= 3 or Harvey Bradshaw index (HBI) <= 16
  • Written and oral consent about participation in the project
  • In a mental and physical state in which every step of the procedure is understood and feasible
  • Ability to obtain and prepare a fecal sample and to use the Smartphone application

Exclusion Criteria:

  • Severe disease activity defined as 6-point Mayo Score > 3 or HBI > 16
  • Unable to read, understand or perform one or several steps of the procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486158


Contacts
Contact: Dag Arne Lihaug Hoff, md phd + 47 70 10 50 00 dag.hoff@helse-mr.no

Locations
Norway
The Outpatient Clinic, Department of gastroenterology, Ålesund Hospital, Helse Møre og Romsdal HF Recruiting
Ålesund, Norway
Contact: Ingrid Prytz Berset, md    + 47 70 10 50 00    ingrid.prytz.berset@helse-mr.no   
Sponsors and Collaborators
Helse Møre og Romsdal HF
Alesund Hospital
Calpro AS
Investigators
Study Director: Dag Arne Lihaug Hoff, md phd Helse Møre & Romsdal HF, Ålesund Hospital

Responsible Party: Helse Møre og Romsdal HF
ClinicalTrials.gov Identifier: NCT03486158     History of Changes
Other Study ID Numbers: 2017/1792
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: ???????????????

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helse Møre og Romsdal HF:
Leukocyte L1 Antigen Complex
Feces
Cell Phone
Biomarkers
Recurrence
Prognosis
Clinical Chemistry Tests

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis