Ulcerative Colitis Clinical Trial
— LYFEMDOfficial title:
Using the LyfeMD Application for Effective Maintenance of Remission and Improved Quality of Life in Crohn's Disease and Ulcerative Colitis: A Randomized Controlled Trial
Background: Alberta's Center of Excellence for Nutrition in Digestive Diseases (Ascend) is dedicated to generating new discoveries regarding the link between nutrition and digestive diseases and mobilizing existing research to change the way physicians treat conditions such as inflammatory bowel disease, cirrhosis and intestinal failure. Ascend is a collaboration of excellence within the Department of Medicine, Division of Gastroenterology at both the University of Calgary and University of Alberta. Dr. Raman, PI, is the Director of Ascend. One of Ascend's primary initiatives is the development of a digital health platform for patients living with both Crohn's disease (CD) and Ulcerative colitis (UC). Dr. Raman and her team have developed an app called LyfeMD, by translating leading scientific research into a practical and engaging digital format. LyfeMD is meant to help people live and thrive while managing their inflammatory disease with holistic, easy-to-implement, evidence based lifestyle therapies. LyfeMD is one app with multiple features - ranging from customized diet using anti-inflammatory principles identified from recent research led by Dr. Raman's team, and exercise plans to mindfulness and stress reduction programs. It helps patients make therapeutic diet choices to treat inflammation and provides stress reduction strategies when they feel unwell. The LyfeMD app also supports patients to maintain remission even when they're feeling well with trusted resources designed to keep them symptom free. In addition to delivering personalized and interactive support, the app uses behavior science to help patients change their habits, improve their health and reduce the burden IBD places on their lives. With proprietary research and a team made up of internationally recognized leaders in the gastrointestinal field, LyfeMD is poised to be the trusted digital health solution for people living with IBD.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | October 15, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 18 years and older - Patients with ileal, ileo-colonic, or colonic luminal CD and UC in clinical remission (Harvey Bradshaw Index <5 or Partial Mayo Score <3) will be invited to participate. - Ability to provide informed consent - Have smart phones to use the app Exclusion Criteria: - Patients more than 80 years old. - Patients will be excluded if they are known to have upper GI Crohn's disease, fistulizing phenotype, > 1 small bowel resection, colectomy, or any psychiatric or neurocognitive comorbidity that would limit compliance. |
Country | Name | City | State |
---|---|---|---|
Canada | TRW building, Foothills, University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Pfizer |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short-form 12-items (SF-12): Change is being assessed. | Assess quality of life | Baseline and 12 week | |
Primary | Perceived stress score 10-item measure (PSS-10): Change is being assessed. | measure the stress level | Baseline and 12 week | |
Primary | Pittsburgh sleep quality index a validated 10-item sleep score (PSQI): Change is being assessed. | Measure the sleep quality | Baseline and 12 week | |
Primary | Godin, a validated 4-item tool: Change is being assessed. | Physical activity minutes will be measured, to estimate weekly physical activity minutes from both moderate and vigorous leisure-time activity. | Baseline and 12 week | |
Primary | 24-item tool from the National Institute for Neurological Disorders and Stroke: Change is being assessed. | To measure the well being and positive aspect | Baseline and 12 week | |
Primary | Generalized anxiety disorder 7-item (GAD-7) tool: Change is being assessed. | To measure the anxiety severity | Baseline and 12 week | |
Primary | Patient health questionnaire 9-item (PHQ-9) tool: Change is being assessed. | To measure depression | Baseline and 12 week | |
Primary | Behaviour compliance: Change is being assessed. | This will be measured by scoring how many goals the patients reports successfully tracking each week in the three different content areas. This is all done inside of the app. | Once every week starting from date of randomization upto week 12 | |
Secondary | 24 hour ASA food recalls: Change is being assessed. | Assess diet quality | Base line and 12 week | |
Secondary | Fecal calprotectin: Change is being assessed. | FCP is a test used to detect inflammation in the colon and is associated with disease activity and severity. | Baseline and 12 week | |
Secondary | Harvey Bradshaw Index (HBI) fro Crohn's disease: Change is being assessed. | HBI is a validated, non-invasive measure of disease activity captured through a symptom questionnaire and is a surrogate to endoscopic assessment to determine disease severity. HBI minimum value is "0" and maximum no limit. HBI < 5 is used in this study to indicate clinical remission. HBI> 16 means severe disease activity. Higher scores means worse outcomes. Based on experience with past recruitment for clinical trials, endoscopic assessment is not feasible due to access and patient acceptance. | Baseline and 12 week | |
Secondary | Partial-Mayo score for ulcerative colitis: Change is being assessed. | Partial Mayo Score (PMS), is a bedside measure of disease activity captured through a symptom questionnaire. It uses the three non-invasive components of the full Mayo Score (stool frequency, rectal bleeding and Physician's global assessment). This excludes the score for the endoscopic findings, therefore the maximum score is reduced from 12 to 9 points (1,2). | Baseline and 12 week |
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