Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00167635
Status:
COMPLETED
Last Update Posted:
2009-05-25
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nursing Management of Irritable Bowel Syndrome:Improving Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-10-10', 'releaseDate': '2017-09-13'}, {'resetDate': '2018-01-08', 'releaseDate': '2017-12-08'}, {'resetDate': '2018-05-03', 'releaseDate': '2018-04-05'}], 'estimatedResultsFirstSubmitDate': '2017-09-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-21', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2009-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal symptoms', 'timeFrame': 'baseline, and 3 months, 6 months, 12 months post randomization'}, {'measure': 'Psychological distress', 'timeFrame': 'baseline, and 3 months, 6 months, 12 months post randomization'}, {'measure': 'Cognitive Scale for Functional Bowel Disorders (CFBD) describes 25 cognitive beliefs related to functional bowel disorders.', 'timeFrame': 'baseline, and 3 months, 6 months, 12 months post randomization'}, {'measure': 'Health Related Quality Of Life (HRQOL) will be measures with the Disease Specific Questionnaire-IBS (IBS-DSQ), a 42-item questionnaire.', 'timeFrame': 'baseline, and 3 months, 6 months, 12 months post randomization'}], 'secondaryOutcomes': [{'measure': 'Sleep disturbance', 'timeFrame': 'baseline, and 3 months, 6 months, 12 months post randomization'}, {'measure': 'Sexual dysfunction', 'timeFrame': 'baseline, and 3 months, 6 months, 12 months post randomization'}, {'measure': 'Catecholamine and cortisol levels (urine)', 'timeFrame': 'baseline, and 3 months, 6 months, 12 months post randomization'}, {'measure': 'Stool frequency/consistency', 'timeFrame': 'baseline, and 3 months, 6 months, 12 months post randomization'}, {'measure': 'Health care utilization', 'timeFrame': 'baseline, and 3 months, 6 months, 12 months post randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Irritable Bowel Syndrome', 'Cognitive-behavioral intervention', 'Psychological distress', 'Quality of life'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '15224283', 'type': 'BACKGROUND', 'citation': 'Heitkemper MM, Jarrett ME, Levy RL, Cain KC, Burr RL, Feld A, Barney P, Weisman P. Self-management for women with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2004 Jul;2(7):585-96. doi: 10.1016/s1542-3565(04)00242-3.'}, {'pmid': '32620184', 'type': 'DERIVED', 'citation': 'Yang PL, Burr RL, Buchanan DT, Pike KC, Kamp KJ, Heitkemper MM. Indirect effect of sleep on abdominal pain through daytime dysfunction in adults with irritable bowel syndrome. J Clin Sleep Med. 2020 Oct 15;16(10):1701-1710. doi: 10.5664/jcsm.8658.'}, {'pmid': '31499231', 'type': 'DERIVED', 'citation': 'Kamp KJ, Weaver KR, Sherwin LB, Barney P, Hwang SK, Yang PL, Burr RL, Cain KC, Heitkemper MM. Effects of a comprehensive self-management intervention on extraintestinal symptoms among patients with IBS. J Psychosom Res. 2019 Nov;126:109821. doi: 10.1016/j.jpsychores.2019.109821. Epub 2019 Aug 29.'}, {'pmid': '28252569', 'type': 'DERIVED', 'citation': 'Han CJ, Kohen R, Jun S, Jarrett ME, Cain KC, Burr R, Heitkemper MM. COMT Val158Met Polymorphism and Symptom Improvement Following a Cognitively Focused Intervention for Irritable Bowel Syndrome. Nurs Res. 2017 Mar/Apr;66(2):75-84. doi: 10.1097/NNR.0000000000000199.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is 1) to determine whether a comprehensive self-management intervention is effective in a sample that includes men and women with irritable bowel syndrome, and 2) to determine whether the comprehensive self-management intervention is as effective when delivered over the telephone as compared to a face-to-face approach.', 'detailedDescription': 'Randomization and Intervention Phase. Upon completing the baseline assessment phase, participants will be randomized to one of 3 treatment groups. A customized computer program will be used to do the randomization in an adaptive manner that ensures the 3 groups remain fairly balanced with respect to possible important predictors of outcomes: age, sex, predominant stool pattern (alternating, constipation-predominant or diarrhea-predominant), and severity of IBS symptoms and psychological symptoms at baseline. When each new participant is randomized, the program will adjust the probabilities of assignment to the three groups so that there is a higher probability of assignment to the group that results in the best balance.\n\nIntervention Groups. Face-to-Face Individualized Comprehensive Self-Management (CSM-FF) Group. Participants in the individualized CSM-FF group will be scheduled for 9 weekly sessions with the nurse therapist followed by post-intervention follow-up assessment.\n\nTelephone Individualized Comprehensive Self-Management (CSM-TEL) Group. Participants in the individualized CSM-TEL group will initially have 2 face-to-face meetings with the nurse therapist, 6 sessions over the phone and the final session face-to-face at 9 weeks.\n\nUsual Care Control Group (UC). Following randomization the participants in the control group will no receive any contacts during the comparable 9-week intervention in the treatment groups.\n\nFollow-up Phase. Participants in all 3 groups will be reassessed at 3-mo, 6-mo, and 12-mo post randomization. At this time the participants will complete questionnaires, a 4 week diary and collect 4 urines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Irritable Bowel Syndrome\n\nExclusion Criteria:\n\n* GI pathology (organic disease)\n* Co-morbid pain disorders'}, 'identificationModule': {'nctId': 'NCT00167635', 'briefTitle': 'Nursing Management of Irritable Bowel Syndrome:Improving Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Nursing Management of Irritable Bowel Syndrome: Improving Outcomes', 'orgStudyIdInfo': {'id': '12707-C'}, 'secondaryIdInfos': [{'id': '2R01NR04142-5'}, {'id': '97-3895-C 11'}, {'id': '2R01NR004142', 'link': 'https://reporter.nih.gov/quickSearch/2R01NR004142', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Face-to-Face Individualized Comprehensive Self-Management (CSM-FF) Group. Participants in the individualized CSM-FF group will be scheduled for 9 weekly sessions with the nurse therapist followed by post-intervention follow-up assessment.', 'interventionNames': ['Behavioral: cognitive-behavioral']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Telephone Individualized Comprehensive Self-Management (CSM-TEL) Group. Participants in the individualized CSM-FTF group will initially have 2 face-to-face meetings with the nurse therapist, 6 sessions over the phone and the final session face-to-face at 9 weeks.', 'interventionNames': ['Behavioral: cognitive-behavioral']}, {'type': 'NO_INTERVENTION', 'label': '3', 'description': 'Usual Care Control Group (UC). Following randomization the participants in the control group will receive two short phone calls to maintain contact during the comparable 9-week intervention in the treatment groups.', 'interventionNames': ['Behavioral: cognitive-behavioral']}], 'interventions': [{'name': 'cognitive-behavioral', 'type': 'BEHAVIORAL', 'otherNames': ['Usual care'], 'description': 'Cognitive-behavioral over 9 weeks', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98125', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Northgate Executive 1', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Margaret M Heitkemper', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Margaret Heitkember', 'oldOrganization': 'University of Washington'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-09-13', 'type': 'RELEASE'}, {'date': '2017-10-10', 'type': 'RESET'}, {'date': '2017-12-08', 'type': 'RELEASE'}, {'date': '2018-01-08', 'type': 'RESET'}, {'date': '2018-04-05', 'type': 'RELEASE'}, {'date': '2018-05-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Margaret Heitkemper, Professor, Biobehavioral Nursing and Health Systems, University of Washington'}}}}