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

NCT03038984 | Active Not Recruiting DMC

• 1 other identifier: H-15005603
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

IBD; Telemedicine; At-home monitoring; Disease activity; fecal calprotectin; Total inflammation burden; 11 years follow up

Outcome Measures

Primary Outcomes (4)

• colectomies

  Number of colectomies

  11 years

• resections

  Number of resections

  11 years

• mortalities

  Number of deaths

  11 years

• cancer

  cancer rates

  11 years

Secondary Outcomes (5)

• Hospitalizations

  11 years

• FC (Fecal Calprotectin) area under the curve (AUC)

  11 years

• Simple clinical colitis activity index (SCCAI): area under the curve (AUC)

  11 years

• Harvey-Bradshaw index (HBI): area under the curve (AUC)

  11 years

• Disease course, Copenhagen IBD Disease course Type

  11 years

Study Arms (2)

Every 3 months

EXPERIMENTAL

screening every 3rd month: (home monitoring: FC and DA)

Behavioral: At Home Screening procedure every 3 months

On demand

ACTIVE COMPARATOR

screening On demand: (home monitoring: FC and DA)

Behavioral: At Home Screening procedure On demand

Interventions

At Home Screening procedure On demand BEHAVIORAL

Home monitoring is a supportive treatment. Patients are randomized to screen themselves on demand

On demand

At Home Screening procedure every 3 months BEHAVIORAL

Home monitoring is a supportive treatment. Patients are randomized to screen themselves every 3 months

Every 3 months

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.

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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Pia Munkholm, Professor

  North Zealand University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Msc food science and Msc Clinical nutrition

Model Details: 120 IBD patients has been randomized to screen for disease activity and FC either OD or every 3 months. 60 patients in each group

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 1, 2017
• Study Start: August 1, 2016
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share