NCT02569333

Brief Summary

Hospitalized patients with ulcerative colitis (UC) are at increased risk for a variety of complications such as infections, venous thrombosis, and surgery. The literature has revealed significant variation in the quality of care to hospitalized UC patients. As a result, guidelines for the management of these patients have been developed. However, the update of guidelines are variable. Admission to hospital can also have significant impact on quality of life due to interruptions in life commitments and lost sense of control of disease. Maintaining a sense of self-control of disease and active participation in care has been shown to be valuable among individuals with chronic diseases. The investigators propose the development of a multi-site, patient centred initiative aimed at improving clinical and patient-centered outcomes through an educational iPad based tool for patients admitted to hospital with ulcerative colitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

September 29, 2015

Last Update Submit

February 26, 2020

Conditions

Colitis, UlcerativeInflammatory Bowel DiseasesColitisIntestinal Disease

Keywords

ulcerative colitisinflammatory bowel diseaseeducationpatient-reported outcomes

Outcome Measures

Primary Outcomes (2)

  • Overall length of stay

    1 year

  • Percentage of patients undergoing colectomy

    1 year

Other Outcomes (7)

  • Proportion of patient undergoing testing of C difficile within 48 hours of admission

    1 year

  • Time from initiation of IV steroids to salvage therapy or surgery.

    1 year

  • Proportion of patients receiving VTE prophylaxis

    1 year

  • +4 more other outcomes

Study Arms (2)

Educational Video

EXPERIMENTAL

Subjects to have access to educational video during hospital stay

Other: Educational video

Usual Care

NO INTERVENTION

Patients to receive usual care and will not have access to educational video.

Interventions

Educational videoOTHER

iPad with educational video highlighting current guidelines for the management of hospitalized patients with ulcerative colitis.

Educational Video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of ulcerative colitis
  • able to provide informed consent
  • admission to hospital with flare of underlying ulcerative colitis

You may not qualify if:

  • Crohn's disease
  • inability to provide informed consent
  • readmission during study period (intervention would only be used on the initial admission during the study period)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (2)

  • Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

    PMID: 40243391DERIVED

  • Weizman AV, Bressler B, Seow CH, Afif W, Afzal NM, Targownik L, Nguyen DM, Jones JL, Huang V, Murthy SK, Nguyen GC. Providing Hospitalized Ulcerative Colitis Patients With Practice Guidelines Improves Patient-Reported Outcomes. J Can Assoc Gastroenterol. 2020 Jun 9;4(3):131-136. doi: 10.1093/jcag/gwaa019. eCollection 2021 Jun.

    PMID: 34061122DERIVED

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel DiseasesColitisIntestinal Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic Diseases

Study Officials

  • Adam V. Weizman, MD, MSc

    MOUNT SINAI HOSPITAL

    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

September 29, 2015

First Posted

October 6, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Locations

CA(1)