Is Relapse Rate Reduced by Home Monitoring of IBD Patients Tightly or on Demand by FC and Disease Activity?

NCT02492555 | Unknown DMC

• 1 other identifier: 48121
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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). 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 ?

Conditions

Inflammatory Bowel Disease

Keywords

IBD; Telemedicine; At-home monitoring; Disease activity; fecal calprotectin

Outcome Measures

Primary Outcomes (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

  1 year

Study Arms (2)

Scheduled (SI)

EXPERIMENTAL

"Scheduled" means screening every 3rd month ( home FC and DA) plus when needed and upgrade of ususal treatment

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

Other: OD

Interventions

SI OTHER

A routine scheduled (SI) screening of FC and DA every 3rd month

Scheduled (SI)

OD OTHER

A screening of FC and DA on demand (OD)

On Demand (OD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

North Zealands Hospital

Frederikssund, Capital Region, 3600, Denmark

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Pia Munkholm, MD

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: July 8, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

DK (1)