Inflammatory Bowel DiseaseNCT02492555
Is Relapse Rate Reduced by Home Monitoring of IBD Patients Tightly or on Demand by FC and Disease Activity?
A study testing SI and OD in people with Inflammatory Bowel Disease, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine if the IBD patient doing home monitoring by web app's for disease activity (DA) and fecal calprotectin (FC) on demand (OD), compared with patients doing home monitoring scheduled interval combined with "on demand"(SI+OD) ( every 3.month). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- SI and OD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2015to Nov 2017
- 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
- IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey \& Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16)
- IBD patients who can read, speak and understand Danish
- IBD patients that can take advantage of the Internet and wireless network 18 years or older
Who cannot join
- IBD patients with severe disease activity ( HB > 16 SCCAI ≥ 5 )
- IBD patients with social, medical or psychological issues of a more complex character
- IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.
- IBD patients who cannot attend due language barrier or cognitive disorder.
- Age less 18.
- When the patient has agreed to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if the IBD patient doing home monitoring by web app's for disease activity (DA) and fecal calprotectin (FC) on demand (OD), compared with patients doing home monitoring scheduled interval combined with "on demand"(SI+OD) ( every 3.month).
Will home monitoring of DA and FC OD vs SI+OD reduce frequency of relapse in one year follow up? Is the frequent FC measurement in SI+OD test group predictive of an early recognition of relapse, and thus help change the naturel course of disease? Will home monitoring of DA and FC in OD vs SI+OD change the course of the disease in terms of disease activity, spread of the disease, hospitalizations and number of hospitalization days, required surgery and outpatient visits? Is there a difference in patients' compliance with treatment plan between OD vs SI+OD ? Is there difference in patients-adherence between OD vs SI+OD ?
Read the detailed description
Detailed Description Among 2.500 IBD patients the investigators will consecutively from the Gastroenterology out-patient clinic at North Zealand University Hospital recruit in total 120 in the study.
At the out-patient consultation IBD patients will be informed about the project and the IBD eHealth nurse ensures that no exclusion criteria met by the patient.
Inclusion criteria: IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey \& Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16) IBD patients who can read, speak and understand Danish IBD patients that can take advantage of the Internet and wireless network 18years or older.
Exclusion criteria: IBD patients with severe disease activity HB > 16 SCCAI ≥ 5 ) IBD patients with social, medical or psychological issues of a more complex character IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.
IBD patients who cannot attend due language barrier or cognitive disorder. Age less 18. When the patient has agreed to participate in the study, randomized to either OD or SI OD 3. Months (SI group):
Patients log in at www.noh.constant-care.dk at least once every 3rd months throughout the project period of 12 months. When the patient log in to the telemedicine platform following scoring must be filled out:
- - Disease activity, respectively SCCAI or HBI.
- - Quality of life assessment, in s - IBDQ every 3rd months.
- - FACIT (Fatigue score)
- - MARS ( Medical Adherence Rating Scale)
- FC, fecal calprotectin mg / kg feces) with SMART phone, rapid home test. If the patients prefer to send the feces test, it will be tested in the Gastro unit lab. at the hospital with SMART phone.
The results of the scoring systems will appear to the health professionals and patients in a traffic light turning into red, yellow and green.
If the patient experiences a recurrence of the disease, it moves from green to either yellow or red area in the traffic graph, and patient will further be instructed to contact Gastro medical clinic project nurse for an early consultation and decision on further treatment initiative. This will also be indicated at the patient's website. If alarm symptoms occurs patients are instructed to contact the project nurse. Thus patients are treated in accordance to national and international guideline. By screening of the inflammation burden the decision is moving forward.
On Demand Group:
Patients log in on demand,detects disease activity, quality of life and FC at the start, and subsequently when needed and at the end of the study (12 months).
At relapse disease activity score and FC is settled and repeated no later than 7 days here after at remission a new DA and FC test should be performed to verify the remission.
Statistical considerations:
Randomization Suitable (N = 120) will be randomized to one of the test groups by sealed envelope principle.
Material size calculation:
A relapse last in median 18 days in patients with inflammatory bowel disease, but the variance is large (10-50 days). During one year of a prevalent IBD patient group 50 % of a patient population will experience a relapse. To assess whether fewer patients experience true "red" indicated by relapse via (TIBS) Feces Calprotectin (FC ) and disease activity in group 1 vs. Group 2 respectively, the sample size has been depicted from TIBS and a statistically significance ( α ) of 0.05 , and test force of ( β ) of 0.8 .
This means that there must be included 53 individuals in each group, which means that there must be included a total of 106. Thus the investigators have chosen to include 120 patients, 60 in each group in order to correct for a possible of small drop out in each group.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- SI, OD
- Keywords
- IBD, Telemedicine, At-home monitoring, Disease activity, fecal calprotectin
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIOther
A routine scheduled (SI) screening of FC and DA every 3rd month
ODOther
A screening of FC and DA on demand (OD)
| Study group | Role | What they receive |
|---|---|---|
| Scheduled (SI) | Experimental | "Scheduled" means screening every 3rd month ( home FC and DA) plus when needed and upgrade of ususal treatment Receives: Other: SI |
| On Demand (OD) | Active comparator | On "Demand" means screening of home FC and DA when the patients feel for it and upgrade of usual treatment Receives: Other: OD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Inflammation Burden Scoring ( TIBS)
The outcome measure of TIBS (FC ( ELISA Smartphone test)and Disease Activity ( Simple Clical Colitis Activity Index or Harvey-Bradshaw Index) has been chosen as endpoint for comparing the two screening methods in relation to relapse rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pia Munkholm, MD, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492555
- Sponsor's protocol ID
- 48121
- Status last verified
- Apr 2017
- First submitted
- 23 Jun 2015
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Relapse Rate Reduced by Home Monitoring of IBD Patients Tightly or on Demand by FC and Disease Activity?
- ClinicalTrials.gov ID
- NCT02492555
- Acronym / sponsor ID
- 48121
- Conditions
- Inflammatory Bowel Disease
- Keywords
- IBD, Telemedicine, At-home monitoring, Disease activity, fecal calprotectin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2017 (estimated)
- First posted
- 8 Jul 2015 (estimated)
- 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 purpose of this study is to determine if the IBD patient doing home monitoring by web app's for disease activity (DA) and fecal calprotectin (FC) on demand (OD), compared with patients doing home monitoring scheduled interval combined with "on demand"(SI+OD) ( every 3.month).
Will home monitoring of DA and FC OD vs SI+OD reduce frequency of relapse in one year follow up? Is the frequent FC measurement in SI+OD test group predictive of an early recognition of relapse, and thus help change the naturel course of disease? Will home monitoring of DA and FC in OD vs SI+OD change the course of the disease in terms of disease activity, spread of the disease, hospitalizations and number of hospitalization days, required surgery and outpatient visits? Is there a difference in patients' compliance with treatment plan between OD vs SI+OD ? Is there difference in patients-adherence between OD vs SI+OD ?
Detailed description
Detailed Description Among 2.500 IBD patients the investigators will consecutively from the Gastroenterology out-patient clinic at North Zealand University Hospital recruit in total 120 in the study.
At the out-patient consultation IBD patients will be informed about the project and the IBD eHealth nurse ensures that no exclusion criteria met by the patient.
Inclusion criteria: IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey \& Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16) IBD patients who can read, speak and understand Danish IBD patients that can take advantage of the Internet and wireless network 18years or older.
Exclusion criteria: IBD patients with severe disease activity HB > 16 SCCAI ≥ 5 ) IBD patients with social, medical or psychological issues of a more complex character IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.
IBD patients who cannot attend due language barrier or cognitive disorder. Age less 18. When the patient has agreed to participate in the study, randomized to either OD or SI OD 3. Months (SI group):
Patients log in at www.noh.constant-care.dk at least once every 3rd months throughout the project period of 12 months. When the patient log in to the telemedicine platform following scoring must be filled out:
- - Disease activity, respectively SCCAI or HBI.
- - Quality of life assessment, in s - IBDQ every 3rd months.
- - FACIT (Fatigue score)
- - MARS ( Medical Adherence Rating Scale)
- FC, fecal calprotectin mg / kg feces) with SMART phone, rapid home test. If the patients prefer to send the feces test, it will be tested in the Gastro unit lab. at the hospital with SMART phone.
The results of the scoring systems will appear to the health professionals and patients in a traffic light turning into red, yellow and green.
If the patient experiences a recurrence of the disease, it moves from green to either yellow or red area in the traffic graph, and patient will further be instructed to contact Gastro medical clinic project nurse for an early consultation and decision on further treatment initiative. This will also be indicated at the patient's website. If alarm symptoms occurs patients are instructed to contact the project nurse. Thus patients are treated in accordance to national and international guideline. By screening of the inflammation burden the decision is moving forward.
On Demand Group:
Patients log in on demand,detects disease activity, quality of life and FC at the start, and subsequently when needed and at the end of the study (12 months).
At relapse disease activity score and FC is settled and repeated no later than 7 days here after at remission a new DA and FC test should be performed to verify the remission.
Statistical considerations:
Randomization Suitable (N = 120) will be randomized to one of the test groups by sealed envelope principle.
Material size calculation:
A relapse last in median 18 days in patients with inflammatory bowel disease, but the variance is large (10-50 days). During one year of a prevalent IBD patient group 50 % of a patient population will experience a relapse. To assess whether fewer patients experience true "red" indicated by relapse via (TIBS) Feces Calprotectin (FC ) and disease activity in group 1 vs. Group 2 respectively, the sample size has been depicted from TIBS and a statistically significance ( α ) of 0.05 , and test force of ( β ) of 0.8 .
This means that there must be included 53 individuals in each group, which means that there must be included a total of 106. Thus the investigators have chosen to include 120 patients, 60 in each group in order to correct for a possible of small drop out in each group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scheduled (SI) | Experimental | Other: SI"Scheduled" means screening every 3rd month ( home FC and DA) plus when needed and upgrade of ususal treatment |
| On Demand (OD) | Active comparator | Other: ODOn "Demand" means screening of home FC and DA when the patients feel for it and upgrade of usual treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey \& Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16)
- IBD patients who can read, speak and understand Danish
- IBD patients that can take advantage of the Internet and wireless network 18 years or older
Key exclusion criteria (6 listed)
- IBD patients with severe disease activity ( HB > 16 SCCAI ≥ 5 )
- IBD patients with social, medical or psychological issues of a more complex character
- IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.
- IBD patients who cannot attend due language barrier or cognitive disorder.
- Age less 18.
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 |
|---|---|---|
| SIA routine scheduled (SI) screening of FC and DA every 3rd month | Other | Scheduled (SI) |
| ODA screening of FC and DA on demand (OD) | Other | On Demand (OD) |
Primary outcome
Total Inflammation Burden Scoring ( TIBS)
Time frame: 1 year
The outcome measure of TIBS (FC ( ELISA Smartphone test)and Disease Activity ( Simple Clical Colitis Activity Index or Harvey-Bradshaw Index) has been chosen as endpoint for comparing the two screening methods in relation to relapse rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Related trials for Inflammatory Bowel Disease
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)
RecruitingPhase 1
A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis
Colitis, Ulcerative
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.
Pia Munkholm, MD principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SI and OD in people with Inflammatory Bowel Disease, run by Nordsjaellands Hospital at 1 site in Denmark.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Apr 2017. 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 Denmark. 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?
Results are not available in the source record.
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?
Total Inflammation Burden Scoring ( TIBS) (time frame: 1 year). 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 12 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.