Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT01349504
Status:
COMPLETED
Last Update Posted:
2013-08-19
First Post:
2011-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-16', 'studyFirstSubmitDate': '2011-04-25', 'studyFirstSubmitQcDate': '2011-05-05', 'lastUpdatePostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data', 'timeFrame': '12 months', 'description': "Participant's adherence behaviour will be measured using a behavioral profile questionnaire, and both the total score, and each individual sub-score, correlated with medication adherence as measured using pharmacy refill rates"}], 'secondaryOutcomes': [{'measure': 'Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6)', 'timeFrame': '12 months', 'description': 'Validated measure of reported medication adherence'}, {'measure': 'Spot Urinary 5-ASA', 'timeFrame': '12 months', 'description': 'Urine salicylic acid and 5-ASA levels will be measured in participants'}, {'measure': 'Short Inflammatory Bowel Disease Questionnaire', 'timeFrame': '12 months', 'description': 'Validated measure of Quality-of-Life for patients with IBD'}, {'measure': 'Pharmacy Refill Rates', 'timeFrame': '12 months', 'description': "Mesalamine refill rates will be captured from patiernts' pharmacies"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis', "Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '24913040', 'type': 'DERIVED', 'citation': 'Moss AC, Lillis Y, Edwards George JB, Choudhry NK, Berg AH, Cheifetz AS, Horowitz G, Leffler DA. Attitudes to mesalamine questionnaire: a novel tool to predict mesalamine nonadherence in patients with IBD. Am J Gastroenterol. 2014 Dec;109(12):1850-5. doi: 10.1038/ajg.2014.158. Epub 2014 Jun 10.'}], 'seeAlsoLinks': [{'url': 'http://www.bidmc.org/CentersandDepartments/Departments/DigestiveDiseaseCenter/InflammatoryBowelDiseaseProgram.aspx', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis:\n\nMesalamine is commonly used to induce and maintain remission in patients with Inflammatory Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in patients with IBD. These factors can be identified using qualitative testing in order to develop a validated instrument to measure the "adherence profile" of an individual patient, and design appropriate behavioral interventions to reduce non-adherence.\n\nObjectives:\n\nTo test a novel interview instrument that determines the medication adherence profile of patients with IBD prescribed mesalamine by correlating with objective measures of adherence', 'detailedDescription': 'Specific Aims:\n\n1. To test a novel interview instrument to classify patients into "adherence profiles"\n2. To validate this instrument with quantitative scores of mesalamine adherence and objective testing.\n\nStudy Design Rationale:\n\nQualitative research design and prospective validation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients taking mesalamine for maintenance of remission of ulcerative colitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (age \\>18)\n* Diagnosis of IBD (confirmed by endoscopy and histology) \\> 3 months\n* In clinical remission (based on Simple Colitis Activity Index score \\<2.5)\n* On mesalamine compound for maintenance of remission\n* Stable mesalamine dose for 1 month\n\nExclusion Criteria:\n\n* Not receiving primary GI care at BIDMC'}, 'identificationModule': {'nctId': 'NCT01349504', 'briefTitle': 'Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': '2011-P-000067/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mesalmine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Alan Moss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shire', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Alan C. Moss', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}