Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-31 @ 10:30 PM
Study NCT ID:
NCT05187806
Status:
COMPLETED
Last Update Posted:
2022-01-12
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing With Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-02', 'size': 293636, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-24T13:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Without knowing that participants are in the experimental or control group'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-24', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2021-12-24', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the pretest-posttest Diabetes Self-management Instrument-35 scores', 'timeFrame': '3 months', 'description': 'The instrument is comprised of 35 questions covering the period from the previous three months to determine the frequency of the implementation of the self-management skills of the patients. The total score for the Instrument ranged from 35 to 140. A higher score showed that self-management activities were implemented on a more regular basis. Interventions consisted of four sessions of 30-60 (mean 45 min) min each. The sessions were structured according to the Behavior Change Stage Identification Form developed by the researcher by making use of the trans-theoretical model and adapting it to diabetic patients.The discussions were completed in four weeks, with one discussion held every week. The final test and the Diabetes Self-Management Instrument were applied again to the members of the intervention group in the third month after completion of the MI method sessions and in the third month to the control group.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the pretest-posttest HbA1c values', 'timeFrame': '3 months', 'description': 'The pretest and posttest HbA1c values of the patients in the experimental and control groups were compared in the third month.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'motivational interviewing', 'HbA1c', 'self management'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This study was conducted in a quasi-experimental research design with a pretest-posttest control group to determine the effect of motivational interviewing on self-management and HbA1c in patients with type 2 diabetes. The sample of the study consisted of 25 experimental and 26 controls, who applied to an outpatient clinic in a training and research hospital.', 'detailedDescription': 'This study was conducted in a quasi-experimental research design with a pretest-posttest control group to determine the effect of motivational interviewing on self-management and HbA1c in patients with type 2 diabetes. The sample of the study consisted of 25 experimental and 26 controls, who applied to an outpatient clinic in a training and research hospital. After the pretest, the experimental group was intervened with a motivational interview (MI) method that consisted of four sessions; the control group received routine treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': '18 years and older', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Having been diagnosed with type 2 diabetes for more than 3 months\n* Being in the contemplation\n* Preparation, and/or action stages of any section of the Behavioral Change Stage Identification Form of the Trans-Theoretical Model\n* Having HbA1c levels above 6\n* Agreeing to take part in the study\n\nExclusion Criteria:\n\n* Having a perception disorder that will prevent communication\n* Having been diagnosed with any mental disorder'}, 'identificationModule': {'nctId': 'NCT05187806', 'briefTitle': 'Motivational Interviewing With Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Effects of Motivational Interviewing Intervention on Self- Management and HbA1c in Type 2 Diabetes Patients', 'orgStudyIdInfo': {'id': 'NursePsychiatric'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'After the pretest, the experimental group was intervened with a motivational interview (MI) method that consisted of four sessions of 30-60 (mean 45 min) min each. The sessions were structured according to the Behavior Change Stage Identification Form developed by the researcher by making use of the trans-theoretical model and adapting it to diabetic patients. The subject of the first session was "Opening, Structuring the Discussion, and Establishing the Agenda"; the subject of the second session was "Improving Motivation for Change"; the subject of the third session was "Summarizing, Support, and Talking about the Change"; and the subject of the fourth session was "Evaluation" . The discussions were completed in four weeks, with one discussion held every week. The final test and the Diabetes Self-Management Instrument were applied again to the members of the intervention group in the third month after completion of the MI method sessions.', 'interventionNames': ['Behavioral: motivational interview']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group received routine treatment. The final test and the Diabetes Self-Management Instrument were applied again to the members of the control group in the third month.'}], 'interventions': [{'name': 'motivational interview', 'type': 'BEHAVIORAL', 'description': 'After the pretest, the experimental group was intervened with a motivational interview (MI) method that consisted of four sessions.The pretest and posttest Diabetes Self-Management Scale total scores and HbA1c values of the patients in the experimental and control groups were compared.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34255', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Ministry of Health, Gaziosmanpasa Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Deniz Kaya Meral, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health, Gaziosmanpasa Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share to Individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Deniz KAYA MERAL', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}