Inflammatory Bowel DiseasesNCT03486158
The CalproSmartNOR Study - a New Clinical Tool for Monitoring Patients With Inflammatory Bowel Disease
A study testing CalproSmart™ system in people with Inflammatory Bowel Diseases, run by Helse Møre og Romsdal HF at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- CalproSmart™ system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteNorway
- Study dates
- 15 Mar 2018to 27 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
The Outpatient Clinic, Department of gastroenterology, Ålesund Hospital, Helse Møre og Romsdal HF
Ålesund
About this study
Official title: Optimalization of Disease Control and Quality of Life in Inflammatory Bowel Disease Using e-Health Measurements Via a Smart Phone Application; CalproSmart
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).
Read the 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).
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- CalproSmart™ system
- Keywords
- Leukocyte L1 Antigen Complex, Feces, Cell Phone, Biomarkers, Recurrence, Prognosis, Clinical Chemistry Tests
- Medical subject headings
- Inflammatory Bowel Diseases, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalproSmart™ systemDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: At baseline, 3, 6, 9 and 12 months according to randomization arm
Secondary outcomes (6)
Time to disease flare
Patients in remission at baseline visit
Measured: At 3, 6, 9 and 12 months according to randomization arm
Time to remission
Patients with mild to moderate disease activity in the course of the study
Measured: At 3, 6, 9 and 12 months according to randomization arm
Quality of life according to disease activity
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
Measured: At baseline and at 12 months
Hospitalization
Number of admission to hospital care due to disease activity
Measured: At 3, 6, 9 and 12 months
Outpatient clinic contacts
Number of contacts to the outpatient clinic care due to disease activity
Measured: At 3, 6, 9 and 12 months
Work activity
Assessed by number of presenteeism /absenteeism at work
Measured: At 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start15 Mar 2018
- Primary completion27 Mar 2020
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Collaborators
- Alesund Hospital, Calpro AS
- Responsible party
- Sponsor
- Investigators
- Dag Arne Lihaug Hoff, md phd, Study director, Helse Møre & Romsdal HF, Ålesund Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486158
- Sponsor's protocol ID
- 2017/1792
- Status last verified
- Apr 2020
- First submitted
- 27 Mar 2018
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimalization of Disease Control and Quality of Life in Inflammatory Bowel Disease Using e-Health Measurements Via a Smart Phone Application; CalproSmart
- ClinicalTrials.gov ID
- NCT03486158
- Acronym / sponsor ID
- 2017/1792
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Leukocyte L1 Antigen Complex, Feces, Cell Phone, Biomarkers, Recurrence, Prognosis, Clinical Chemistry Tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Collaborators
- Alesund Hospital, Calpro AS
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CalproSmart application | Experimental | Device: CalproSmart™ systemIn 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalproSmart™ systemHome 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) | Device | CalproSmart application |
Primary outcome
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.
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
6 secondary outcomes
Time to disease flare
Time frame: At 3, 6, 9 and 12 months according to randomization arm
Time to remission
Time frame: At 3, 6, 9 and 12 months according to randomization arm
Quality of life according to disease activity
Time frame: At baseline and at 12 months
Hospitalization
Time frame: At 3, 6, 9 and 12 months
Outpatient clinic contacts
Time frame: At 3, 6, 9 and 12 months
Work activity
Time frame: At 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dag Arne Lihaug Hoff, md phd study director
Helse Møre & Romsdal HF, Ålesund Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CalproSmart™ system in people with Inflammatory Bowel Diseases, run by Helse Møre og Romsdal HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease activity index 1 (time frame: At baseline 3, 6, 9 and 12 months according to randomization arm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.