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
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Perceived stress score 10-item measure (PSS-10): Change is being assessed.
研究概览
简要总结
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.
详细描述
Study Objectives:
- To identify if the LyfeMD app improves diet quality, perceived stress, depression, anxiety, well-being, quality of life, sleep, and physical activity minutes.
- To identify if the LyfeMD app helps improve intestinal inflammation measured by fecal calprotectin in CD and UC patients in clinical remission.
Methods:
This 1-year study at the University of Calgary (n=44) will have a RCT study design. Participants will be randomly allocated to receive the intervention LyfeMD mobile application (INT) for 12-weeks or conventional management (CM) from the IBD clinic at the Foothills hospital.
Intervention Group(INT): The INT group (n=22) will meet with the health coach over the phone or video chat. The health coach will orient the participant to the LyfeMD app, answer technology related questions and ensure that the participant has received a nutrition plan in the app. Participants will be asked to complete the app assessment tools to design a personalized nutrition, physical activity and yoga and meditation program. Participants will set goals in each area that they are interested in implementing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Perceived stress score 10-item measure (PSS-10): Change is being assessed.
时间窗: Baseline and 12 week
measure the stress level
Godin, a validated 4-item tool: Change is being assessed.
时间窗: Baseline and 12 week
Physical activity minutes will be measured, to estimate weekly physical activity minutes from both moderate and vigorous leisure-time activity.
Behaviour compliance: Change is being assessed.
时间窗: Once every week starting from date of randomization upto week 12
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.
Short-form 12-items (SF-12): Change is being assessed.
时间窗: Baseline and 12 week
Assess quality of life
Pittsburgh sleep quality index a validated 10-item sleep score (PSQI): Change is being assessed.
时间窗: Baseline and 12 week
Measure the sleep quality
24-item tool from the National Institute for Neurological Disorders and Stroke: Change is being assessed.
时间窗: Baseline and 12 week
To measure the well being and positive aspect
Generalized anxiety disorder 7-item (GAD-7) tool: Change is being assessed.
时间窗: Baseline and 12 week
To measure the anxiety severity
Patient health questionnaire 9-item (PHQ-9) tool: Change is being assessed.
时间窗: Baseline and 12 week
To measure depression
次要结局
- 24 hour ASA food recalls: Change is being assessed.(Base line and 12 week)
- Fecal calprotectin: Change is being assessed.(Baseline and 12 week)
- Partial-Mayo score for ulcerative colitis: Change is being assessed.(Baseline and 12 week)
- Harvey Bradshaw Index (HBI) fro Crohn's disease: Change is being assessed.(Baseline and 12 week)
研究者
Maitreyi Raman
Clinical Associate Professor, Director Clinician Investigator Program (CIP), Medical Director Alberta's Collaboration of Excellence for Nutrition in Digestive Diseases (Ascend) , Medical Director Nutrition Services
University of Calgary