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

• Sponsor: Helse Møre og Romsdal HF
• Collaborators: Alesund Hospital; Calpro AS
• Information provided by (Responsible Party): Helse Møre og Romsdal HF

Study Description

Brief Summary:

The aim of this study is to prove that getting immediate calprotectin test results on the patients Smartphone (platforms such as Android or Iphone), 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 e-Health 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 application (platforms such as Android or Iphone), 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 (platforms such as Android or Iphone); 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 (platforms such as Android or Iphone).

Study Design

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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 :	March 2020
Estimated Study Completion Date :	March 2020

Arms and Interventions

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 (platforms such as Android o Iphone)
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 Fecal-calprotectin tube and envelope and are instructed to obtain fecal samples and send these to local lab if they experience symptoms suspect of recurrent IBD

Outcome Measures

Primary Outcome Measures :

1. Change in disease activity index 1 [ Time Frame: At baseline 3, 6, 9 and 12 months according to randomization arm ]
   Crohn disease and Ulcerative colitis acidity measured using the Harvey-Bradshaw index ( total score 0-20 points, where < than 3 indicate remission and > 7 indicates severe disease ) and 6 point Mayo Score (total score 0-6, > 2 indicates moderate to severe disease.
2. Change in disease activity index 2 [ Time Frame: At baseline, 3, 6, 9 and 12 months according to randomization arm ]
   Fecal Calprotectin (mg/kg) where < 50 indicates no activity, 50-200 remission and > 250 activity - moderate to severe

Secondary Outcome Measures :

1. Time to disease flare [ Time Frame: At 3, 6, 9 and 12 months according to randomization arm ]
   Patients in remission at baseline visit
2. Time to remission [ Time Frame: At 3, 6, 9 and 12 months according to randomization arm ]
   Patients with mild to moderate disease activity in the course of the study
3. Quality of life according to disease activity [ Time Frame: At baseline and at 12 months ]
   The Norwegian validation study (N-IBDQ) revealed a five-dimensional structure: emotional function-1 (fatigue, energy), bowel function-1 (stool consistency and pattern), bowel function-2 (bowel pain and discomfort), social function (work attendance, cancelling social events) and emotional function-2 (worries). All of the responses were scored on a 7-point Likert Scale, with a score of 7 representing no problems and a score of 1 representing severe problems. This gives a possible score range of 32-224, with a higher score reflecting improved HRQoL
4. Hospitalization [ Time Frame: At 3, 6, 9 and 12 months ]
   Number of admission to hospital care due to disease activity
5. Outpatient clinic contacts [ Time Frame: At 3, 6, 9 and 12 months ]
   Number of contacts to the outpatient clinic care due to disease activity
6. Work activity [ Time Frame: At 3, 6, 9 and 12 months ]
   Assessed by number of presenteeism /absenteeism at work

Eligibility Criteria

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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 (platforms such as Android or Iphone)

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

Contacts and Locations

Contacts

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

Locations

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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

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Study Director:	Dag Arne Lihaug Hoff, md phd	Helse Møre & Romsdal HF, Ålesund Hospital

More Information

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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
Last Update Posted:	February 27, 2019
Last Verified:	February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	???????????????

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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:

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Intestinal Diseases; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis