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

NCT03486158 | Completed

• 1 other identifier: 2017/1792
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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).

Conditions

Inflammatory Bowel Diseases

Keywords

Leukocyte L1 Antigen Complex; Feces; Cell Phone; Biomarkers; Recurrence; Prognosis; Clinical Chemistry Tests

Outcome Measures

Primary Outcomes (2)

• Change in disease activity index 1

  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.

  At baseline 3, 6, 9 and 12 months according to randomization arm

• Change in disease activity index 2

  Fecal Calprotectin (mg/kg) where \< 50 indicates no activity, 50-200 remission and \> 250 activity - moderate to severe

  At baseline, 3, 6, 9 and 12 months according to randomization arm

Secondary Outcomes (6)

• Time to disease flare

  At 3, 6, 9 and 12 months according to randomization arm

• Time to remission

  At 3, 6, 9 and 12 months according to randomization arm

• Quality of life according to disease activity

  At baseline and at 12 months

• Hospitalization

  At 3, 6, 9 and 12 months

• Outpatient clinic contacts

  At 3, 6, 9 and 12 months

Study Arms (2)

CalproSmart application

EXPERIMENTAL

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

Standard follow-up

NO INTERVENTION

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

Interventions

CalproSmart™ system DEVICE

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)

CalproSmart application

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead
• Alesund Hospital: collaborator
• Calpro AS: collaborator

Study Sites (1)

The Outpatient Clinic, Department of gastroenterology, Ålesund Hospital, Helse Møre og Romsdal HF

Ålesund, Norway

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Recurrence

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dag Arne Lihaug Hoff, md phd

  Helse Møre & Romsdal HF, Ålesund Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 3, 2018
• Study Start: March 15, 2018
• Primary Completion: March 27, 2020
• Study Completion: March 27, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)