Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients ?

April 14, 2022 updated by: Dorit Vedel Ankersen, Nordsjaellands Hospital

Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients Tightly on Demand or Every 3 Months by Fecal Calprotectin and Disease Activity?

This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555. The purpose of this study is to determine if the IBD patients doing home monitoring (screening themselves on demand (OD) or every 3 months) have relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD patients are self-monitoring by web apps consisting of a short disease activity questionnaire (DA) and fecal calprotectin (FC) on any smart phone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555. Among 2.500 IBD patients the investigators have consecutively from the Gastroenterology out-patient clinic at North Zealand University Hospital recruited in total 120 in the study.

At the out-patient consultation IBD patients has been informed about the project and the IBD eHealth nurse has ensured that no exclusion criteria was met by the patients.

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. 18 years 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 than 18.

When the patient has agreed to participate in the study, randomized to either OD or 3. Months (This has been done ClinicalTrials.gov ID: NCT02492555)

Patients log in to www.noh.constant-care.dk at least once every 3rd months throughout the project period of 11 years in total (2015-2026). When the patient log in to the telemedicine platform the following scorings must be filled out:

  1. - Disease activity (DA), respectively SCCAI or HBI.
  2. - Quality of life assessment, s-IBDQ
  3. - FACIT (Fatigue score)
  4. - MARS ( Medical Adherence Rating Scale)
  5. - FC, fecal calprotectin mg / kg measured by the patient's own SMART phone, rapid home test.

If the patients prefer to send the fecal samples for test, it will be analyzed in the ehealth gastro lab. at the hospital with a SMART phone as well.

The results of the scoring systems will appear to the health care professionals and patients in a traffic light manner (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 (web algorithm), the decision is moving forward.

Patients logging in on demand, indicate disease activity, quality of life and FC at the start, and subsequently when needed and at the end of the study (after 11 years from inclusion).

At relapse, disease activity score and FC is settled and repeated no later than 7 days here after. When the patient has reached remission (green) a new DA and FC test should be performed to verify the remission.

The purpose of this study is to determine if the IBD patients doing home monitoring have relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of web monitoring. Relative reduced rates of colectomies etc. means - relative to standard care but also if there is a difference between the two web screening procedures on these endpoints.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Every 3 months
screening every 3rd month: (home monitoring: FC and DA)
Behavioral: At Home Screening procedure every 3 months
Home monitoring is a supportive treatment. Patients are randomized to screen themselves every 3 months
ACTIVE_COMPARATOR: On demand
screening On demand: (home monitoring: FC and DA)
Behavioral: At Home Screening procedure On demand
Home monitoring is a supportive treatment. Patients are randomized to screen themselves on demand

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
colectomies
Time Frame: 11 years
Number of colectomies
11 years
resections
Time Frame: 11 years
Number of resections
11 years
mortalities
Time Frame: 11 years
Number of deaths
11 years
cancer
Time Frame: 11 years
cancer rates
11 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospitalizations
Time Frame: 11 years
number of hospitalizations and days
11 years
FC (Fecal Calprotectin) area under the curve (AUC)
Time Frame: 11 years
Both AUC total, but also as a red >600 mg/kg, yellow (200-600 mg/kg) and green (below 200mg/kg ) AUC will be performed from the individualized curves
11 years
Simple clinical colitis activity index (SCCAI): area under the curve (AUC)
Time Frame: 11 years
Both AUC total, but also as a red >5, yellow (2-4) and green (< 2 ) AUC will be performed from the individualized curves
11 years
Harvey-Bradshaw index (HBI): area under the curve (AUC)
Time Frame: 11 years
Both AUC total, but also as a red >16 , yellow (6-16) and green (≤5) AUC will be performed from the individualized curves
11 years
Disease course, Copenhagen IBD Disease course Type
Time Frame: 11 years

Based on epidemiology four figures have been developed to describe disease-course of IBD. These figures have been used in a retrospective study (Maagaard et al. 2016) to measure change in Disease course.The four figures depicting different types of disease courses is described as follows:

  1. Mild IBD with indolent course
  2. Mild IBD with aggressive course
  3. Chronic IBD with continuous course
  4. Chronic IBD with intermittent course The patients have to choose one figure representing their disease course type the best at inclusion and 11 years later
11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nordsjaellands Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pia Munkholm, Professor, North Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-15005603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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