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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Denmark1 site
  • North Zealands Hospital

    Frederikssund, Capital Region, 3600

Other trials in Denmark

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:

  1. - Disease activity, respectively SCCAI or HBI.
  2. - Quality of life assessment, in s - IBDQ every 3rd months.
  3. - FACIT (Fatigue score)
  4. - 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.

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 groups in NCT02492555
Study groupRoleWhat 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 comparatorOn "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.

  1. 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.

  1. First posted8 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionAug 2016
  4. Study completionNov 2017 (estimated)

Resources

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)
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

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.

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