Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-28 @ 6:30 PM
Study NCT ID:
NCT05719766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-21
First Post:
2023-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-18', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-01-31', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved score of Quality of Life after three months', 'timeFrame': 'three months', 'description': 'Improvement score of quality of life via short inflammatory bowel disease questionnaire(SIBDQ, score scale:0\\~70 points) after intervention for three months,higher scores mean better quality of life.'}], 'secondaryOutcomes': [{'measure': 'Decreased score of Socially activity limited rating', 'timeFrame': 'three months,one year', 'description': 'Improvement score of socially activity limited rating after intervention for three months, or one year.'}, {'measure': 'Decreased score of Hospital Anxiety and Depression Scale', 'timeFrame': 'three months,one year', 'description': 'improvement score of anxiety or depression via Hospital Anxiety and Depression Scale after intervention for three months, or one year. Lower scores mean the less anxiety or depression of the patients.'}, {'measure': 'Increasion of disease kownledge', 'timeFrame': 'three months,one year', 'description': "improvement of disease kownledge via Crohn's and Colitis Knowledge Score(CCKOWN， score scale: 0\\~24 points) after intervention for three months, or one year. Higher scores mean better knowledge."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases', 'Crohn Disease', 'Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '40243391', 'type': 'DERIVED', 'citation': 'Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.'}]}, 'descriptionModule': {'briefSummary': "This study aims to prospectively explore the effect of incentive-integrated E-IBD (electronic inflammatory bowel disease) chronic disease management model on the improvement of IBD quality of life, and provide a more effective chronic disease management model for improving the quality of life and social participation of IBD patients.The investigators firstly identify the IBD patients in need of empowerment disease activities through the questionnaire .Then, the investigators feedback the patients' education content according to their needs found.Based on the social support network of patient organization and the medical support network of tertiary medical institutions, the investigators complete the empowerment process of IBD patients' self-management initiative and self-management ability, through the internet. Finally ,the investigators evaluate the quality of life(QoL), social participation,disease self-management level via questionnaire . The primary outcome is the improvement of QoL score after three months' intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Clinically diagnosed IBD patients,according to the criteria of the Inflammatory Bowel Group of the Gastroenterology Branch of the Chinese Medical Association in 2018;\n* 2.Aged 18 to 75 years old;\n* 3.Understand and comply with the requirements of the program and sign informed consent.\n* 4.Identified as need intervention according to the patient identification questionnaire screening;\n* 5.Patients with the ability to complete all course training and/or follow-up work;\n* 6.Enrolled at least one year ahead of end of this study(for garantee of enough folllow-up time).\n\nExclusion Criteria:\n\n* 1.Unable or unwilling to sign the consent form, or unable to follow the research procedure;\n* 2.Patients who have had a stoma or ileorectal anastomosis (partial scales are not available);\n* 3.Patients who do not complete training on time or do not complete follow-up assessments in their entirety;\n* 4.Patients with other malignancies or life-threatening complications；\n* 5.Pregnancy or lactation；\n* 6.Patients whose remaining follow-up time less than one year before the end of this study.'}, 'identificationModule': {'nctId': 'NCT05719766', 'briefTitle': 'Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Perspective Study on How Can the Incentive Integrated E-IBD Chronic Disease Management Model Improve the Quality of Life in IBD Patients', 'orgStudyIdInfo': {'id': '20230049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine follow-up group'}, {'type': 'EXPERIMENTAL', 'label': 'IBD Disease Management Research Group', 'interventionNames': ['Other: education ,psycological support and social support']}], 'interventions': [{'name': 'education ,psycological support and social support', 'type': 'OTHER', 'description': "we would give targeted-education according to our patients' need(reflected via questionnaire; we would provide psycological and social support to patients based on their need reflected by questionnaire", 'armGroupLabels': ['IBD Disease Management Research Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'country': 'China', 'contacts': [{'name': 'Yan chen, PhD,MD', 'role': 'CONTACT', 'email': 'chenyan72_72@zju.edu.cn', 'phone': '+8613757118653'}], 'facility': 'Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Huzhou', 'country': 'China', 'contacts': [{'name': 'Jiang Liu, PhD', 'role': 'CONTACT'}], 'facility': 'Department of Gastroenterology, Huzhou Central Hospital', 'geoPoint': {'lat': 30.8703, 'lon': 120.0933}}, {'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Jie Zhong, PhD,MD', 'role': 'CONTACT', 'email': 'jimmyzj64@medmail.com.cn'}], 'facility': 'Department of Gastroenterology, Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shaoxing', 'country': 'China', 'contacts': [{'name': 'Yazhen Zhan, MD', 'role': 'CONTACT'}], 'facility': 'Department of Gastroenterology, Shaoxing Central Hospital', 'geoPoint': {'lat': 30.00237, 'lon': 120.57864}}], 'centralContacts': [{'name': 'Yan chen, PhD, MD', 'role': 'CONTACT', 'email': 'chenyan72_72@zju.edu.cn', 'phone': '+8613757118653'}, {'name': 'Shiyuan Lu, PhD', 'role': 'CONTACT', 'email': '2322135@zju.edu.cn', 'phone': '+8618868110373'}], 'overallOfficials': [{'name': 'Yan chen', 'role': 'STUDY_CHAIR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}