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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03486158
• Date of registration: 27/03/2018
• Prospective Registration: No
• Primary sponsor: Helse Møre og Romsdal HF
• Public title: The CalproSmartNOR Study - a New Clinical Tool for Monitoring Patients With Inflammatory Bowel Disease
• Scientific title: Optimalization of Disease Control and Quality of Life in Inflammatory Bowel Disease Using e-Health Measurements Via a Smart Phone Application; CalproSmart
• Date of first enrolment: March 15, 2018
• Target sample size: 109
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03486158
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Dag Arne Lihaug Hoff, md phd
• Affiliation: Helse Møre & Romsdal HF, Ålesund Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Diseases

Intervention(s)

Device: CalproSmart™ system

Primary Outcome(s)

Change in disease activity index 2 [Time Frame: At baseline, 3, 6, 9 and 12 months according to randomization arm]

Change in disease activity index 1 [Time Frame: At baseline 3, 6, 9 and 12 months according to randomization arm]

Secondary Outcome(s)

Time to remission [Time Frame: At 3, 6, 9 and 12 months according to randomization arm]

Outpatient clinic contacts [Time Frame: At 3, 6, 9 and 12 months]

Time to disease flare [Time Frame: At 3, 6, 9 and 12 months according to randomization arm]

Work activity [Time Frame: At 3, 6, 9 and 12 months]

Hospitalization [Time Frame: At 3, 6, 9 and 12 months]

Quality of life according to disease activity [Time Frame: At baseline and at 12 months]

Secondary ID(s)

2017/1792

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Alesund Hospital

Calpro AS