[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628048":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":56,"collaborators":59,"id":63,"slug":26,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard care","ACTIVE_COMPARATOR","Care as usual",[13],"Behavioral: Standard Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care plus digital self-management program","EXPERIMENTAL","24-week digital self-management program",[19,13],"Behavioral: Digital self-management program",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Digital self-management program","Participants will receive this 24-week digital self-management program that was developed for patients with inflammatory bowel disease in addition to standard care. The program will be accessed through the web or a mobile device and will include different modules that will help support in managing participant's symptoms and disease both in the short-term as well as helping to build habits and skills to support participants in managing disease long-term. Participants are not required to use the self-management program and may stop using it at any time without any penalty to standard inpatient treatment. Additionally, participants will be asked to complete a follow-up self-report questionnaire at week 8 and week 12, and a clinician assessment at week 12. After 24 weeks a final remote visit or video meeting will be completed.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Care","Participants will have baseline assessment of symptoms both based on self-report and a clinician's assessment, and review the electronic health record for standard of care inflammatory biomarker measurements. In addition, questionnaires will be collected and visit completed at 8,12, and 24-week follow-ups.",[15,9],[32],{"name":33,"affiliation":5,"role":34},"Shirley Cohen-Mekelburg, MD, MS","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","734-845-5735","shcohen@med.umich.edu",[41],{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of Micigan","Ann Arbor","Michigan","48109","United States",{"type":48,"coordinates":49},"Point",[50,51],-83.74088,42.27756,{"lat":51,"lon":50},[54,55],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Shirley Cohen-Mekelburg","Assistant Professor",[60],{"name":61,"class":62},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100628048",false,"NCT07456566","Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease","Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial","Inclusion Criteria:\n\n* Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, endoscopic, and histopathological criteria, clinically active IBD\n* Impaired health-related quality of life\n* Clinically active IBD will be indicated by both a modified Harvey Bradshaw Index (HBI) ≥5 for Crohn's disease (CD) or a Simple Clinical Colitis Activity Index (SCCAI) ≥3 for ulcerative colitis (UC)\n* Fecal calprotectin \\> 250 microgram (ug\u002Fg)\n* Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60\n\nExclusion Criteria:\n\n* Unable to speak and read English\n* Unable to access the internet regularly by phone or web as this will impair participants ability to engage with the intervention components\n* Have an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses\n* Are planned for imminent surgery\n* Have short bowel syndrome\n* Uncontrolled medical or psychiatric disease","ALL","18 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"NA","This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease.\n\nThe study team hypothesizes:\n\n* the study will achieve a recruitment rate of 10 participants every 3 months\n* 70% participant retention at 24 weeks\n* 70% outcome data collection\n* 70% intervention completion\n* high acceptability",[79,80,81],"Inflammatory Bowel Diseases","Ulcerative Colitis","Crohn Disease",[23,83,84,85],"Standard of care","Randomization","Questionnaires","NOT_YET_RECRUITING","2026-06-30",{"date":89,"type":90},"2026-07-02","ACTUAL",{"date":92,"type":73},"2026-07",{"date":94,"type":73},"2028-03",{"name":5,"class":6},1]