Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-26 @ 7:48 AM
Study NCT ID:
NCT04225403
Status:
COMPLETED
Last Update Posted:
2020-01-14
First Post:
2019-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telephone-based Motivational Interviewing for Smoking Cessation in Crohn's Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2019-12-23', 'studyFirstSubmitQcDate': '2020-01-09', 'lastUpdatePostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The rate of patients who had received the 5 A intervention referred to the smoking cessation unit.', 'timeFrame': 'We measure it at baseline and through study completion, 1 year after', 'description': 'Control visits in Hospital smoking cessation Unit'}, {'measure': 'The rate of patients who had received the 5 R intervention referred to the smoking cessation unit.', 'timeFrame': 'We measure it at baseline and through study completion, 1 year after', 'description': 'Control visits in Hospital smoking cessation Unit'}], 'primaryOutcomes': [{'measure': 'Change from motivation to quit smoking after at one year in the control group and in the experimental group', 'timeFrame': 'We measure it at baseline and through study completion, 1 year after', 'description': 'Test de Richmond: to measure the motivation to quit smoking. It consists of 4 questions, scores from 0 to 10, highest score, highest motivation. It provides three categories, low motivation \\<4 points, medium motivation 5-6 and high motivation ≥7'}, {'measure': 'Change from stages of changes to quit smoking after at one year in the control group and in the experimental group', 'timeFrame': 'We measure it at baseline and through study completion, 1 year after', 'description': 'Stages of changes form Prochaska / DiClemente. Transtheoretical model of change consists of 4 mutually exclusive questions and has a legend where it classifies patients according to the state of the wheel of change in which they are: pre-contemplation, preparation, action, maintenance, consolidation and relapse.'}], 'secondaryOutcomes': [{'measure': "Number of patients with Crohn's disease who quit smoking at the end of the study in the control group and in the experimental group.", 'timeFrame': 'We measure it at baseline and through study completion, 1 year after', 'description': 'Cosnes classification: current smokers \\>7 cigarettes per week for at least 6 months, former smokers who had stopped smoking at least 6 months before.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease', 'Smoking cessation', 'Tobacco', 'Smoking', 'Advanced practice nurse', 'Motivational intervention'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '11266373', 'type': 'RESULT', 'citation': "Cosnes J, Beaugerie L, Carbonnel F, Gendre JP. Smoking cessation and the course of Crohn's disease: an intervention study. Gastroenterology. 2001 Apr;120(5):1093-9. doi: 10.1053/gast.2001.23231."}, {'pmid': '27018116', 'type': 'RESULT', 'citation': "Kaplan GG. Smoking Cessation for Crohn's Disease: Clearing the Haze. Am J Gastroenterol. 2016 Mar;111(3):420-2. doi: 10.1038/ajg.2016.45."}, {'pmid': '29509882', 'type': 'RESULT', 'citation': "Kemp K, Dibley L, Chauhan U, Greveson K, Jaghult S, Ashton K, Buckton S, Duncan J, Hartmann P, Ipenburg N, Moortgat L, Theeuwen R, Verwey M, Younge L, Sturm A, Bager P. Second N-ECCO Consensus Statements on the European Nursing Roles in Caring for Patients with Crohn's Disease or Ulcerative Colitis. J Crohns Colitis. 2018 Jun 28;12(7):760-776. doi: 10.1093/ecco-jcc/jjy020. No abstract available."}, {'pmid': '27016849', 'type': 'RESULT', 'citation': "Underner M, Perriot J, Cosnes J, Beau P, Peiffer G, Meurice JC. [Smoking, smoking cessation and Crohn's disease]. Presse Med. 2016 Apr;45(4 Pt 1):390-402. doi: 10.1016/j.lpm.2016.02.008. Epub 2016 Mar 23. French."}, {'pmid': '26981632', 'type': 'RESULT', 'citation': 'Cosnes J. Smoking and Diet: Impact on Disease Course? Dig Dis. 2016;34(1-2):72-7. doi: 10.1159/000442930. Epub 2016 Mar 16.'}, {'pmid': '27481416', 'type': 'RESULT', 'citation': "To N, Gracie DJ, Ford AC. The Importance of Smoking Cessation in Improving Disease Course in Crohn's Disease. Am J Gastroenterol. 2016 Aug;111(8):1198. doi: 10.1038/ajg.2016.165. No abstract available."}, {'pmid': '34269705', 'type': 'DERIVED', 'citation': 'Navarro Correal E, Casellas Jorda F, Borruel Sainz N, Robles Alonso V, Herrera de Guise C, Ibarz Casas A, Sanchez Garcia JM, Vila Morte G, Fuentelsaz Gallego C. Effectiveness of a Telephone-Based Motivational Intervention for Smoking Cessation in Patients With Crohn Disease: A Randomized, Open-Label, Controlled Clinical Trial. Gastroenterol Nurs. 2021 Nov-Dec 01;44(6):418-425. doi: 10.1097/SGA.0000000000000572.'}]}, 'descriptionModule': {'briefSummary': "Quitting smoking unequivocally improves the course of Crohn's disease (EC), and therefore, it should be one of the main therapeutic targets in the treatment of this disease. The goal of the study was to know the effectiveness of motivational intervention 5 R for smoking cessation in patients with Crohn's disease performed by telephone by nursing, in relation to those who did not receive such intervention.\n\nFor this purpose, a controlled, randomized, parallel and open clinical trial was designed. The subjects were patients with Crohn's disease that were actively smoking EC. They were all \\>18 years old and they had internet access and e-mail. Those who were already in a process of smoking cessation were excluded from the study. Experimental intervention consisted of a motivational intervention for smoking cessation through telephone every 3 months for one year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Smokers Crohn's disease patients\n* \\>18 age\n\nExclusion Criteria:\n\n* Smokers Crohn's disease patients who are receiving treatment of tobacco cessation at the time of inclusion\n* Do not have email"}, 'identificationModule': {'nctId': 'NCT04225403', 'briefTitle': "Telephone-based Motivational Interviewing for Smoking Cessation in Crohn's Disease Patients", 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': "Telephone-based Motivational Interviewing Delivered by IBD ( Inflammatory Bowel Disease) Nurses for Smoking Cessation in Crohn's Disease: a Randomized Open-label Clinical Trial", 'orgStudyIdInfo': {'id': 'PR(AG)275/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telephone-based motivational interviewing', 'description': 'Experimental intervention consisted of a motivational intervention for smoking cessation through telephone every 3 months for one year, performed by IBD nurse', 'interventionNames': ['Behavioral: Telephone-based motivational interviewing for smoking cessation']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'No intervention consisted of a single telephone contact one year after the star of the study'}], 'interventions': [{'name': 'Telephone-based motivational interviewing for smoking cessation', 'type': 'BEHAVIORAL', 'description': 'The motivational brief intervention is known by the acronym 5 R and lasts about 5-10 minutes. It is an approach based on the principles of motivational interviewing and develops the intervention in five short steps:\n\n* Relevance. Help patients identify why personal reasons may be relevant to quitting smoking.\n* Risks. Help identify what negative consequences tobacco use has.\n* Rewards. Help identify potential benefits of quitting smoking.\n* Resistors. Help patients identify barriers to smoking cessation, which can often include fear of withdrawal symptoms, failure, wainweight, face social situations, etc.\n* Repeat. Repeat the intervention at 3 months if you do not advance at the stage of change.', 'armGroupLabels': ['Telephone-based motivational interviewing']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ester Navarro Correal, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hospital Universitari Vall d'Hebron Research Institute"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'GETTEII ( Grupo Enfermero de Trabajo en Enfermedad Inflamatoria Intestinal', 'class': 'UNKNOWN'}, {'name': 'Department of Health, Generalitat de Catalunya', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}