Real World Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention (MONITOR Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Medication Adherence
研究概览
简要总结
The goal of this observational study is to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization in patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, and inflammatory bowel disease type undetermined) initiating therapy with vedolizumab (Entvyio). The main questions it aims to answer are:
- Assess and compare adherence to intravenous (IV) and subcutaneous vedolizumab maintenance therapy in patients with IBD using a novel remote monitoring system.
- Assess symptom response to vedolizumab post induction (week 6-8) and during maintenance therapy (week 22) using a novel remote monitoring system.
- Assess time to response to vedolizumab during induction (weeks 0-6) using a novel remote monitoring system.
Researchers will compare medication adherence between participants using IV and subcutaneous vedolizumab maintenance therapy to see if adherence is lower with self-administration.
Participants will be asked to register adherence to medication using the novel remote monitoring system each time they take a dose of vedolizumab and to respond to two questions about bowel symptoms weekly for the first 6 weeks after starting vedolizumab then monthly thereafter for 6 months. Additionally, participants will be asked to enter information regarding demographics and social determinants of health at baseline and other variables listed below at baseline and at weeks 2, 6, 14, and 22 post baseline unless otherwise denoted:
- MARS-5
- Healthcare utilization (22 weeks only)
- Harvey Bradshaw Index (Crohn's disease only)
- Simple clinical colitis activity index (Ulcerative colitis only)
- PROMIS Global Health Scale
- PROMIS Anxiety
- PROMIS Depression
- PROMIS Sleep Disturbance
- PROMIS Pain Interference
- PROMIS Physical Function
- IBD Self-Efficacy
- Attitudinal Survey (22 weeks only)
详细描述
The proposed study is a multicenter, open label, clinical trial to be conducted over 22 weeks. Participants will verify medication adherence using the Tappt web-based system. Additionally, participants will complete a two-item assessment of symptoms at baseline, weekly for 6 weeks, then monthly through week 22.
All participants are required to complete electronic data entry forms at baseline, 2, 6, 14, and 22 weeks. Adherence, disease activity, quality of life, PROs, and IBD self-efficacy will be measured at each time point during the 22-week study. Health care utilization will be measured at 22 weeks. Demographic and clinical information will be collected at the baseline visit. Questions regarding social determinants of health will be assessed at baseline.
Participants will be recruited for this study from seven clinical centers: Capital Digestive Care, MMC (lead site), New York University, Tulane University, University of North Carolina (data management center), University of Cincinnati, and Vanderbilt University. Of note, New York University has access to a disadvantaged population at NYC Health + Hospitals / Bellevue and a community site on Long Island.
Patients with an ostomy will be excluded since calculation of bowel movement frequency is not possible in this setting. For similar reasons, investigators will exclude patients who have undergone total or subtotal colectomy and/or that have short bowel syndrome. In these patients, clinical symptoms are less reliable to distinguish quiescent from active disease. Active disease will not be required for entry into the study.
All the participant's concomitant medications will be continued during the study. Addition of new IBD medications will be allowed during the study. If the new medication replaces vedolizumab, the replacement medication will be similarly tracked.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age or older
- •Have documented IBD based on usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology
- •Initiating treatment with vedolizumab
- •Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access
- •Ability to understand the protocol and provide informed consent in English or Spanish
排除标准
- •Inability to speak and read English or Spanish
- •Unable to comply with the study protocol including inability to access the internet and/or inadequate access to a smart device
- •Unable to access vedolizumab due to insurance restrictions
- •Unable to follow up at respective sites due to insurance restrictions or other barriers (i.e., distance from patient's home to study site)
- •Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis
- •Imminent surgery (within the next 60 days)
- •History of short bowel syndrome
- •Uncontrolled medical or psychiatric disease at the opinion of the investigator
- •Degenerative neurologic condition
- •Unstable angina
- •Symptomatic peripheral vascular disease
- •Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin)
- •Poorly controlled depression, mania, and schizophrenia
- •Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics)
结局指标
主要结局
Medication Adherence
时间窗: From enrollment to the end of the study (22 weeks).
The primary outcome of the proposed study will be the difference in mean medication possession ratio (MPR) between intravenous and subcutaneous vedolizumab during the 22-week study. The mean MPR will be calculated as follows: MPR = number days' supply of medication obtained over observation period/total number days in observation period.
Self Reported Medication Adherence
时间窗: From enrollment to the end of the study (22 weeks).
Self-reported adherence will be assessed with the MARS-5 questionnaire. MARS-5 is a reliable and validated instrument which includes five questions; responses are ranked on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores for each item are summed to give a total score, with higher scores indicating higher levels of reported adherence.
次要结局
- Disease Activity Crohn's Disease(From enrollment to the end of the study (22 weeks).)
- Healthcare Utilization(From enrollment to the end of the study (22 weeks).)
- Quality of Life(From enrollment to the end of the study (22 weeks).)
- Anxiety(From enrollment to the end of the study (22 weeks).)
- Depression(From enrollment to the end of the study (22 weeks).)
- Sleep Disturbance(From enrollment to the end of the study (22 weeks).)
- Fatigue(From enrollment to the end of the study (22 weeks).)
- Pain Interference(From enrollment to the end of the study (22 weeks).)
- Frailty(From enrollment to the end of the study (22 weeks).)
- Self-Efficacy(From enrollment to the end of the study (22 weeks).)
- Disease activity (UC)(From enrollment to the end of the study (22 weeks).)
- Short Disease Activity Crohn's Disease(From enrollment to the end of the study (22 weeks).)
- Short Disease Activity UC(From enrollment to the end of the study (22 weeks).)
- Serum Biomarker Disease Activity(From enrollment to the end of the study (22 weeks).)
- Fecal Biomarker Disease Activity(From enrollment to the end of the study (22 weeks).)
- Endoscopic Disease Activity CD(From enrollment to the end of the study (22 weeks).)
- Endoscopic Disease Activity UC(From enrollment to the end of the study (22 weeks).)
研究者
Raymond Cross
Director Center for Inflammatory Bowel and Colorectal Diseases
Mercy Medical Center