ISRCTN11043249进行中（未招募）未知
An observational study to assess the relationship between disease flare states and patient-reported health data, health data from a wearable activity tracker, and biomarker data obtained through a decentralized process in patients with inflammatory bowel disease
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 01/08/2022:
- •1. Age of more than 18 years
- •2. Diagnosis of moderate-severe CD or UC by a healthcare provider via colonoscopy
- •3. One or more IBD flares in the previous 12 months, with a flare defined as an occurrence in an unplanned visit to a primary gastroenterologist or IBD specialist or the initiation of treatment to manage IBD or due to change in the medical management of IBD by a healthcare provider
- •4. The participant is a resident of the United States and can speak, read, and understand English
- •5. Agree to wear an activity tracker on the same wrist 24 hours a day (except when charging the tracker) for the duration of the study
- •6. Agreement to self-collect saliva and stool samples and store one stool sample in the freezer until pick-up at least every 4 weeks
- •7. Must have a smartphone that is compatible with the IBDoc CalApp (list of compatible devices is available at: https://www.ibdoc.net/support/?lang=en) and must be able to take an at-home stool test and upload results using a smartphone app every 2 weeks
- •8. Agreement and ability to store up to four sample kits in the refrigerator during the study
- •9. Agreement and ability to receive shipments at a mailing address that is not a post office box
- •10. Agreement and ability to have a mobile phlebotomist collect blood, stool, and saliva samples at home or at a place of their choosing at least every 4 weeks during phlebotomist business hours
- •11. Agreement to complete daily and weekly questionnaires
- •Previous inclusion criteria:
- •1. Age of more than 18 years
- •2. Diagnosis of moderate-severe CD or UC by a healthcare provider via colonoscopy
- •3. Two or more IBD flares in the previous 24 months, with a flare defined as an occurrence in an unplanned visit to a primary gastroenterologist or IBD specialist or the initiation of treatment to manage IBD or due to change in the medical management of IBD by a healthcare provider
- •4. The participant is a resident of the United States and can speak, read, and understand English
- •5. Agree to wear an activity tracker on the same wrist 24 hours a day (except when charging the tracker) for the duration of the study
- •6. Agreement to self-collect saliva and stool samples and store one stool sample in the freezer until pick-up at least every 4 weeks
- •7. Agreement to donate a blood sample for genome testing
- •8. Must have a smartphone that is compatible with the IBDoc CalApp (list of compatible devices is available at: https://www.ibdoc.net/support/?lang=en) and must be able to take an at-home stool test and upload results using a smartphone app every 2 weeks
- •9. Agreement and ability to store up to four sample kits in the refrigerator during the study
- •10. Agreement and ability to receive shipments at a mailing address that is not a post office box
- •11. Agreement and ability to have a mobile phlebotomist collect blood, stool, and saliva samples at home or at a place of their choosing at least every 4 weeks during phlebotomist business hours
- •12. Agreement to complete daily and weekly questionnaires
排除标准
- •Current exclusion criteria as of 01/08/2022:
- •1.Has a diagnosis of ischemic/radiation colitis
- •2. Has a diagnosis of primary sclerosing cholangitis
- •3. Has a diagnosis of an abdominal abscess or perianal abscess requiring surgical intervention or antibiotic treatment within the past 3 months
- •4. Has a history of cancer, excluding non-melanoma skin cancer that was completely removed
- •5. Has a history of organ transplant
- •6. Diagnosis of, or treatment for, infectious colitis, such as CMV colitis or Clostridium difficile colitis, within the past 60 days
- •7. Hospitalization within the past 8 weeks
- •8. Participation in a treatment program for drug, alcohol, or chemical abuse in the past 6 months
- •9. Use of biologics for non-IBD conditions
- •10. Use of an immune-modulating medication treating a condition other than IBD or its complications
- •11. Planned IBD abdominal surgery
- •12. Participation in a clinical trial that involves blood draws, any treatment or procedure for IBD, or a change in IBD care within the past 3 months
- •13. Current participation in a clinical trial that involves blood draws, any treatment or procedure for IBD, or a change in regular IBD care, or intending to participate in such a trial within the next 12 months
- •Previous exclusion criteria:
- •1. Has a diagnosis of a non-IBD autoimmune condition
- •2. Has a diagnosis of indeterminate/ischemic/radiation colitis
- •3. Has a diagnosis of primary sclerosing cholangitis
- •4. Has a diagnosis of an abdominal abscess or perianal abscess in the past 2 years
- •5. For participants with CD: diagnosis of intestinal strictures or intestinal fistula
- •6. Has a history of cancer, excluding non-melanoma skin cancer that was completely removed
- •7. Has a history of organ transplant
- •8. Diagnosis of, or treatment for, infectious colitis, such as CMV colitis or Clostridium difficile colitis, within the past 60 days
- •9. Hospitalization within the past 8 weeks
- •10. Participation in a treatment program for drug, alcohol, or chemical abuse in the past 6 months
- •11. Use of biologics for non-IBD conditions
- •12. Use of an immune-modulating medication treating a condition other than IBD or its complications
- •13. Prior or scheduled IBD abdominal surgery
- •14. Participation in a clinical trial that involves blood draws, any treatment or procedure for IBD, or a change in IBD care within the past 3 months
- •15. Current participation in a clinical trial that involves blood draws, any treatment or procedure for IBD, or a change in regular IBD care, or intending to participate in such a trial within the next 12 months
研究者
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