Ulcerative Colitis Clinical Trial
Official title:
Improving Outcomes Among Urgent Care Clinic Patients With Inflammatory Bowel Disease (URGENT-IBD)
Inflammatory Bowel Diseases (IBD) refers to a category of disorders, consisting of Crohn's Disease (CD) and Ulcerative Colitis (UC), where segments of the gastrointestinal tract become inflamed and ulcerated. Canada has among the highest incidence rates of IBD in the world - 16.3 and 12.3 per 100,000 for CD and UC respectively. In the absence of a cure, the current goal of treatment is to manage patients in a milder state of remission. However, maintaining (or even achieving) remission is dependent on timely access to specialist IBD care; which in light of rising incidence rates have proven to be challenging. Moreover, patients often experience flare-ups of their gastrointestinal symptoms, while awaiting access to specialist care. In recent years, there has been increased integration of telemedicine services in gastroenterology practice. This change has been driven by a desire among IBD patients to have more flexible follow-up care, where 'virtual' care is provided as an adjunct to in-person consultations. Within the context of IBD, telemedicine might be effective in delivering routine and timely follow-up care to high-risk patients. The purpose of this study to determine whether telemedicine-based follow-up care can effectively manage the gastrointestinal symptoms of high-risk IBD patients and reduce their need for preventive health care services.
Inflammatory Bowel Diseases (IBD) refers to a category of disorders, consisting of Crohn's
Disease (CD) and Ulcerative Colitis (UC), where segments of the gastrointestinal tract become
inflamed and ulcerated. Canada has among the highest incidence rates of IBD in the world -
16.3 and 12.3 per 100,000 for CD and UC respectively. Moreover, IBD care spans a broad range
of inpatient, outpatient, and emergency services; which vary across populations due to the
heterogeneous nature of these conditions. The economic burden of IBD in Canada is estimated
to be $2.8 billion per anum, where direct health care costs (i.e. medications,
hospitalizations, physician visits) alone exceed $1.2 billion.
In the absence of a cure, the current goal of treatment is to manage patients in a milder
state of remission. However, maintaining (or even achieving) remission is dependent on timely
access to specialist IBD care; which in light of rising incidence rates have proven to be
challenging. Wait times for gastroenterology care are currently in excess of guidelines
outlined by the Canadian Association of Gastroenterology - Wait Times Consensus Group.
Moreover, patients often experience flare-ups of their gastrointestinal symptoms, while
awaiting access to specialist care.
In recent years, there has been increased integration of telemedicine services in
gastroenterology practice. This change has been driven by a desire among IBD patients to have
more flexible follow-up care, where 'virtual' care is provided as an adjunct to in-person
consultations. Telemedicine is the process by which medical information is transferred
between providers and patients through an electronic interface (i.e. two-way video,
smartphone applications and secure messaging). Within the context of IBD, telemedicine might
be effective in delivering routine and timely follow-up care to high-risk patients. It's also
enticing to speculate that if telemedicine follow-up care can adequately manage the
gastrointestinal symptoms of high-risk patients, then it may also reduce their need for
preventive health care services and alleviate some of the economic burden associated with
these conditions.
Therefore, the purpose of this study to determine whether telemedicine-based follow-up care
can effectively manage the gastrointestinal symptoms of high-risk IBD patients and reduce
their need for preventive health care services. As part of this study, we will attempt to
recruit all IBD outpatients, who were seen at the Mount Sinai Hospital urgent care clinic.
These are a subset of high-risk IBD patients, who often have moderate to severe exacerbations
of their medical condition.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05702879 -
Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
|
||
Not yet recruiting |
NCT05953402 -
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
|
||
Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
Recruiting |
NCT03950232 -
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
Completed |
NCT03124121 -
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
|
Phase 4 | |
Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
Withdrawn |
NCT04209556 -
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
|
Phase 2 | |
Terminated |
NCT00061282 -
Clotrimazole Enemas for Pouchitis in Children and Adults
|
Phase 1/Phase 2 | |
Recruiting |
NCT04398550 -
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
|
N/A | |
Recruiting |
NCT04314375 -
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
|
Phase 4 | |
Active, not recruiting |
NCT04857112 -
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
|
Phase 2 | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Active, not recruiting |
NCT04033445 -
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
Active, not recruiting |
NCT06221995 -
Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
|
||
Recruiting |
NCT04767984 -
Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis
|
Phase 2 | |
Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
Recruiting |
NCT06071312 -
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
|
Phase 1/Phase 2 | |
Completed |
NCT03760003 -
Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
|
Phase 2 | |
Not yet recruiting |
NCT05539625 -
Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis
|
Phase 2 |