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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03038984
• Other study ID #: H-15005603
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2026

Study information

• Verified date: April 2022
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

Behavioral:
• At Home Screening procedure On demand
Home monitoring is a supportive treatment. Patients are randomized to screen themselves on demand
• At Home Screening procedure every 3 months
Home monitoring is a supportive treatment. Patients are randomized to screen themselves every 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colectomies	Number of colectomies	11 years
Primary	resections	Number of resections	11 years
Primary	mortalities	Number of deaths	11 years
Primary	cancer	cancer rates	11 years
Secondary	Hospitalizations	number of hospitalizations and days	11 years
Secondary	FC (Fecal Calprotectin) area under the curve (AUC)	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
Secondary	Simple clinical colitis activity index (SCCAI): area under the curve (AUC)	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
Secondary	Harvey-Bradshaw index (HBI): area under the curve (AUC)	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
Secondary	Disease course, Copenhagen IBD Disease course Type	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: Mild IBD with indolent course; Mild IBD with aggressive course; Chronic IBD with continuous course; 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