Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:54 AM
Study NCT ID:
NCT07456566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'It will be difficult to effectively blind the participants and research staff to the intervention, but the study team will avoid unnecessary inquiry about allocation or hypothesized outcomes with participants and clinicians.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant recruitment rate', 'timeFrame': '2 years (during the recruitment period)', 'description': 'Feasibility will be defined by participant recruitment rate (the proportion of the proposed sample size who enroll to participate in the study over time). The study team hypothesize that the team will achieve a recruitment rate of 10 participants every 3 months.'}, {'measure': 'The proportion of enrolled participants that complete the study without dropout', 'timeFrame': '24 weeks', 'description': 'Feasibility will be defined by retention (the proportion enrolled participants who complete the study without dropout). The study team hypothesize that 70% participant retention at 24 weeks,'}, {'measure': 'The proportion of study assessments completed by the participant', 'timeFrame': '24 weeks', 'description': 'Feasibility willed be defined by the outcome assessment completion (the proportion of study assessments completed by participant). The study team hypothesize that 70% outcome data collection.'}, {'measure': 'Qualitative interviews - self-management program group', 'timeFrame': '24 weeks', 'description': 'Protocol acceptability will be determined based on post-intervention qualitative data. Discussion with participants will be facilitated by questions focusing on feedback about intervention characteristics, including content and functionality (e.g., usability, timing, frequency) and evaluate helpfulness, likes and dislikes, barriers and facilitators to use, and suggestions for improvement.'}], 'secondaryOutcomes': [{'measure': 'Theoretical Framework of Acceptability (TFA)', 'timeFrame': '24 weeks', 'description': "Intervention acceptability will be measured using a 19-item Likert scale questionnaire developed from Sekhon's Theoretical Framework of Acceptability (TFA).TFA is organized into seven domains that are important to assess the acceptability of healthcare interventions from the perspective of those receiving the intervention (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy). The 19-item questionnaire uses a 5-point Likert scale, where responses ranged from 5 (strongly agree) to 1 (strongly disagree). Scores range from 19-95 with higher scores representing higher acceptability."}, {'measure': 'Treatment Acceptability Adherence Scale (TAAS)', 'timeFrame': '24 weeks', 'description': 'The 10-item TAAS was developed to assess both the acceptability of psychological interventions and anticipated adherence. The TAAS uses a 7-point Likert scale (1 = disagree strongly to 7 = agree strongly) for each item. Total scores range from 10 to 70, with higher scores indicating greater acceptability and anticipated adherence.'}, {'measure': 'Qualitative interviews - self-management program group', 'timeFrame': '24 weeks', 'description': 'Intervention acceptability will be determined based on post-intervention qualitative data. Discussion with participants will be facilitated by questions focusing on feedback about intervention characteristics, including content and functionality (e.g., usability, timing, frequency) and evaluate helpfulness, likes and dislikes, barriers and facilitators to use, and suggestions for improvement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital self-management program', 'Standard of care', 'Randomization', 'Questionnaires'], 'conditions': ['Inflammatory Bowel Diseases', 'Ulcerative Colitis', 'Crohn Disease']}, 'descriptionModule': {'briefSummary': "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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/g)\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"}, 'identificationModule': {'nctId': 'NCT07456566', 'briefTitle': 'Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial', 'orgStudyIdInfo': {'id': 'HUM00246865'}, 'secondaryIdInfos': [{'id': '1K23DK136928-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23DK136928-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Care as usual', 'interventionNames': ['Behavioral: Standard Care']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Care plus digital self-management program', 'description': '24-week digital self-management program', 'interventionNames': ['Behavioral: Digital self-management program', 'Behavioral: Standard Care']}], 'interventions': [{'name': 'Digital self-management program', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Standard Care plus digital self-management program']}, {'name': 'Standard Care', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Standard Care plus digital self-management program', 'Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'Shirley Cohen-Mekelburg, MD, MS', 'role': 'CONTACT', 'email': 'shcohen@med.umich.edu', 'phone': '734-845-5735'}, {'name': 'Shirley Cohen-Mekelburg, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Micigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Shirley Cohen-Mekelburg, MD, MS', 'role': 'CONTACT', 'email': 'shcohen@med.umich.edu', 'phone': '734-845-5735'}], 'overallOfficials': [{'name': 'Shirley Cohen-Mekelburg, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Shirley Cohen-Mekelburg', 'investigatorAffiliation': 'University of Michigan'}}}}