Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 1:13 PM
Study NCT ID:
NCT05628259
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2022-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Tele-Nursing Based Motivational Interviewing in Individuals With Type 2 Diabetes:RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D052456', 'term': 'Hypoalphalipoproteinemias'}, {'id': 'D008064', 'term': 'Lipidoses'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007009', 'term': 'Hypolipoproteinemias'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single blinding was provided that included inclusion criteria and agreement to participate in the study.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a parallel group randomized controlled study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-10', 'studyFirstSubmitDate': '2022-11-17', 'studyFirstSubmitQcDate': '2022-11-25', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes Self-Efficacy Scale', 'timeFrame': 'Change from Baseline diabetes self-efficacy at 6 months', 'description': 'The change in diabetes self efficacy of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Self-Efficacy Scale.'}, {'measure': 'Diabetes Self-Management Scale', 'timeFrame': 'Change from Baseline diabetes self-management at 6 months', 'description': 'This scale was used to measure the behavioral component of individuals in the IMB model. The validity and reliability study of the Turkish Diabetes Self-Management Perception Scale was conducted by Eroğlu and Sabuncu (2018). The scale consists of 16 items and 4 sub-dimensions and is a 4-point Likert type. Glucose Management sub-dimension: Items 4, 6, 10, 12 (items 4 and 12 are about drug use, items 1, 6 and 10 are about blood glucose monitoring). Diet Control sub-dimension: Items 2, 5, 9, 13. Physical Activity sub-dimension: Items 8, 11, 15. Use of Health Services sub-dimension: It consists of 3, 7, 14, and 16 items. The DMS scale consists of 16 items, 7 of which are straight and 9 of which are reversed. The scores of the items numbered "5, 7, 10, 11, 12, 13, 14, 15 and 16" in the scale are calculated by reversing them. Diabetes self-management increases as the score gets closer to 10.'}], 'secondaryOutcomes': [{'measure': 'HbA1c%', 'timeFrame': 'Change from Baseline HbA1c% at 6 months', 'description': 'Hemoglobin A1C'}, {'measure': 'BMI', 'timeFrame': 'Change from Baseline Body Mass Index at 6 months', 'description': 'Body Mass Index'}, {'measure': 'FBG', 'timeFrame': 'Change from Baseline Fasting glucose at 6 months', 'description': 'Fasting blood glucose'}, {'measure': 'LDL', 'timeFrame': 'Change from Baseline LDL at 6 months', 'description': 'Low-density lipoprotein'}, {'measure': 'HDL', 'timeFrame': 'Change from Baseline HDL at 6 months', 'description': 'High-density lipoprotein'}, {'measure': 'waist circumference', 'timeFrame': 'Change from Baseline waist circumference at 6 months', 'description': 'waist circumference'}, {'measure': 'Total cholesterol', 'timeFrame': 'Change from Baseline total cholesterol at 6 months', 'description': 'Total cholesterol'}, {'measure': 'Triglyceride', 'timeFrame': 'Change from Baseline total triglyceride at 6 months', 'description': 'triglyceride'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes', 'Self Efficacy', 'Self Management', 'Tele-nursing', 'Motivational Interview', 'LDL - Low Density Lipoprotein Receptor Disorder', 'High Density Lipoprotein Deficiency', 'Cholesterol; Lipidosis']}, 'referencesModule': {'references': [{'pmid': '39982630', 'type': 'DERIVED', 'citation': 'Isleyen EK, Ozdemir IN, Yoldemir SA. The effect of tele-nursing based motivational interviewing on self-efficacy, self-management and metabolic control parameters in individuals with type 2 diabetes: randomized controlled study. Ir J Med Sci. 2025 Apr;194(2):563-573. doi: 10.1007/s11845-025-03916-5. Epub 2025 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'This study carried out to examine the effect of tele-nursing based motivational interviewing on diabetes self-efficacy, diabetes self-management and metabolic control parameters (Body mass index, waist circumference, HbA1c%,fasting blood glucose, LDL cholesterol, HDL cholesterol, total cholesterol, triglyceride) in individuals with type 2 diabetes.', 'detailedDescription': 'The first researcher of the article who applied Motivational Interviewing Techniques has a "Motivational Interviewing Techniques Training" certificate. A motivational interview (MI) program based on the telenursing approach was prepared by the researchers based on the literature for the individuals in the experimental group. In this study, the MI procedure includes eight sessions in total, with four sessions of motivational interviews by phone in the first month of the intervention and four sessions of motivational interviews by phone in the next two months for each individual. Pre-tests were collected in the first month. Afterwards, MI intervention was applied for three months. This intervention was applied to the experimental group in addition to the routine care provided by the hospital. MI application took an average of 45-60 minutes via phone call.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) being over 18 years old, 2) receiving insulin or insulin + oral therapy, 3) diagnosis of type 2 diabetes at least one year ago, 4) having a BMI of 25 and above, 5) HbA1c value of 7 and above, 6) access to phone, 7) voluntarily agreeing to participate in the study.\n\nExclusion Criteria:\n\n1\\) have a physical disability.'}, 'identificationModule': {'nctId': 'NCT05628259', 'briefTitle': 'The Effect of Tele-Nursing Based Motivational Interviewing in Individuals With Type 2 Diabetes:RCT', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'The Effect of Tele-Nursing Based Motivational Interviewing on Diabetes Self-Efficacy, Diabetes Self-Management and Metabolic Control Parameters in Individuals With Type 2 Diabetes: Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'EKILINCISLEYEN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'A motivational interview (MI) program based on the telenursing approach was applied to the individuals in the experimental group. In this study, the MI procedure includes eight sessions in total, with four sessions of motivational interviews by phone in the first month of the intervention and four sessions of motivational interviews by phone in the next two months for each individual. Pre-tests were collected in the first month. Afterwards, MI intervention was applied for three months. This intervention was applied to the experimental group in addition to the routine care provided by the hospital. MI application took an average of 45-60 minutes via phone call.', 'interventionNames': ['Behavioral: Tele-Nursing based Motivational Interviewing']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group received routine nursing care in the diabetes policlinic.'}], 'interventions': [{'name': 'Tele-Nursing based Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'A motivational interview (MI) program based on the telenursing approach was applied to the individuals in the experimental group. In this study, the MI procedure includes eight sessions in total, with four sessions of motivational interviews by phone in the first month of the intervention and four sessions of motivational interviews by phone in the next two months for each individual. Pre-tests were collected in the first month. Afterwards, MI intervention was applied for three months. This intervention was applied to the experimental group in addition to the routine care provided by the hospital. MI application took an average of 45-60 minutes via phone call.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '(545)-561 96 83', 'city': 'Pamukkale', 'state': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Eda Kılınç İşleyen', 'geoPoint': {'lat': 37.91644, 'lon': 29.11729}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'İrem Nur ÖZDEMİR', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Şengül AYDIN YOLDEMİR', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Eda KILINÇ İŞLEYEN, PhD. RN.', 'role': 'STUDY_CHAIR', 'affiliation': 'Uşak University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Profesor Dr.', 'investigatorFullName': 'EDA KILINÇ İŞLEYEN', 'investigatorAffiliation': 'Pamukkale University'}}}}