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

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: Active, not recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Behavioral: At Home Screening procedure every 3 months; Behavioral: At Home Screening procedure On demand

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: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
colectomies	Number of colectomies	11 years
resections	Number of resections	11 years
mortalities	Number of deaths	11 years
cancer	cancer rates	11 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalizations	number of hospitalizations and days	11 years
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
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
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
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

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Study Director: Pia Munkholm, Professor, North Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ANTICIPATED): August 1, 2026
• Study Completion (ANTICIPATED): August 1, 2026

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (ESTIMATE): February 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; IBD; Disease activity; fecal calprotectin; At-home monitoring; Total inflammation burden; 11 years follow up
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID 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