Ignite Creation Date:
2025-12-25 @ 1:59 AM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
Study NCT ID:
NCT06178094
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2023-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Video Training Given to Individuals With Type 2 Diabetes
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-24', 'studyFirstSubmitDate': '2023-10-30', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Numerical distribution of participants' sociodemographic and diabetes-related characteristics", 'timeFrame': 'At the first meeting (initial)', 'description': 'The sociodemographic and diabetes-related characteristics of the training and control groups.\n\nSociodemographic characteristics; Age, gender, marital status, education level, occupation, income level, smoking and alcohol use were evaluated.\n\nCharacteristics of diabetes: duration of diabetes, diabetes treatment method, use of other medications, family history of diabetes, frequency of check-ups, hospitalization due to high blood sugar, hospitalization due to hypoglycemia, chronic complications due to diabetes, previous education on diabetes, status other than diabetes the presence of the disease was evaluated.'}, {'measure': 'Diabetes Self-Care Scale mean score', 'timeFrame': 'At the first interview (baseline) and at the second interview 3 months later', 'description': "The comparison of Diabetes Self-Care Scale pre-test, post-test and change difference values between training and control groups. The lowest acceptable level of the scale is 92 points. The highest score that can be obtained from the scale is 140 points. As the score of the scale increases, patients' self-care activities also increase positively."}, {'measure': 'Fasting plasma glucose value', 'timeFrame': 'At the first interview (baseline) and at the second interview 3 months later', 'description': "Comparison of fasting plasma glucose variables between training and control groups.\n\nFasting plasma glucose (mg/dl) value was obtained as a result of the participant's routine blood test."}, {'measure': 'HbA1c value', 'timeFrame': 'At the first interview (baseline) and at the second interview 3 months later', 'description': "Comparison of HbA1c variables between training and control groups. HbA1c (%) value was obtained as a result of the participant's routine blood test."}, {'measure': 'Total cholesterol value', 'timeFrame': 'At the first interview (baseline) and at the second interview 3 months later', 'description': "Comparison of total cholesterol variables between training and control groups. Total cholesterol (mg/dl) value was obtained as a result of the participant's routine blood test."}, {'measure': 'Low-density lipoprotein value', 'timeFrame': 'At the first interview (baseline) and at the second interview 3 months later', 'description': "Comparison of low-density lipoprotein variables between training and control groups.\n\nLow density lipoprotein (mg/dl) value was obtained as a result of the participant's routine blood test."}, {'measure': 'High-density lipoprotein value', 'timeFrame': 'At the first interview (baseline) and at the second interview 3 months later', 'description': "Comparison of high-density lipoprotein variables between training and control groups.\n\nHigh density lipoprotein (mg/dl) value was obtained as a result of the participant's routine blood test."}, {'measure': 'Triglyceride value', 'timeFrame': 'At the first interview (baseline) and at the second interview 3 months later', 'description': "Comparison of triglyceride variables between training and control groups. Triglyceride (mg/dl) value was obtained as a result of the participant's routine blood test."}, {'measure': 'Systolic blood pressure value', 'timeFrame': 'At the first interview (baseline) and at the second interview 3 months later', 'description': 'Comparison of systolic blood pressure (mmHg) variables between training and control groups.\n\nThe tools required for blood pressure measurement were provided by the researcher. The same measurement tools were used in the first interview (pretest) and the second interview (posttest). The participant was allowed to rest for at least 5-10 minutes before the measurement. An aneroid type sphygmomanometer, suitable for adults, was used as a measurement tool. In accordance with the technique recommended in the National Hypertension Treatment and Follow-up Guide, the researcher took measurements twice with an interval of two minutes while the participant was in a sitting position, with his right arm supported at heart level, and the results were recorded by averaging the measurements.'}, {'measure': 'Diastolic blood pressure value', 'timeFrame': 'At the first interview (baseline) and at the second interview 3 months later', 'description': 'Comparison of diastolic blood pressure (mmHg) variables between training and control groups.\n\nThe tools required for blood pressure measurement were provided by the researcher. The same measurement tools were used in the first interview (pretest) and the second interview (posttest). The participant was allowed to rest for at least 5-10 minutes before the measurement. An aneroid type sphygmomanometer, suitable for adults, was used as a measurement tool. In accordance with the technique recommended in the National Hypertension Treatment and Follow-up Guide, the researcher took measurements twice with an interval of two minutes while the participant was in a sitting position, with his right arm supported at heart level, and the results were recorded by averaging the measurements.'}, {'measure': 'Body Mass Index value', 'timeFrame': 'At the first interview (baseline) and at the second interview 3 months later', 'description': "Comparison of body mass index variables between training and control groups. To calculate the body mass index of the participants, they were measured according to the weight and height technique. Participants' BMI was calculated by dividing their weight by the square of their height \\[BMI: Weight (kg)/height (m2)\\]. BMI was evaluated in accordance with WHO recommendations."}, {'measure': 'Waist circumference value', 'timeFrame': 'At the first interview (baseline) and at the second interview 3 months later', 'description': 'Comparison of waist circumference variables between training and control groups.\n\nWaist circumference measurement was made using the measurement technique recommended by WHO. While the participants were standing, the circumference was measured with a tape measure over their underwear, at the midpoint between the lowest rib and the crista iliaca at the end of expiration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes training,', 'Metabolic control variables', 'Self-care', 'Type 2 Diabetes', 'Video training'], 'conditions': ['Diabetes Mellitus, Type 2', 'Training']}, 'referencesModule': {'references': [{'pmid': '33422431', 'type': 'BACKGROUND', 'citation': 'Kang J, Chen Y, Zhao Y, Zhang C. Effect of remote management on comprehensive management of diabetes mellitus during the COVID-19 epidemic. Prim Care Diabetes. 2021 Jun;15(3):417-423. doi: 10.1016/j.pcd.2020.12.004. Epub 2021 Jan 1.'}, {'pmid': '28325823', 'type': 'RESULT', 'citation': 'Hansen CR, Perrild H, Koefoed BG, Zander M. Video consultations as add-on to standard care among patients with type 2 diabetes not responding to standard regimens: a randomized controlled trial. Eur J Endocrinol. 2017 Jun;176(6):727-736. doi: 10.1530/EJE-16-0811. Epub 2017 Mar 21.'}, {'pmid': '16192661', 'type': 'RESULT', 'citation': 'Lee NP, Fisher WP Jr. Evaluation of the Diabetes Self-Care Scale. J Appl Meas. 2005;6(4):366-81.'}, {'pmid': '32444190', 'type': 'RESULT', 'citation': 'Avdal EU, Uran BNO, Pamuk G, Yildirim JG, Konakci G, Ates M, Polat G. Investigation of the effect of web-based diabetes education on metabolic parameters in people with type 2 diabetes: A randomized controlled trial. J Infect Public Health. 2020 Dec;13(12):1892-1898. doi: 10.1016/j.jiph.2020.03.008. Epub 2020 May 20.'}, {'pmid': '22538140', 'type': 'RESULT', 'citation': 'Bell AM, Fonda SJ, Walker MS, Schmidt V, Vigersky RA. Mobile phone-based video messages for diabetes self-care support. J Diabetes Sci Technol. 2012 Mar 1;6(2):310-9. doi: 10.1177/193229681200600214.'}, {'pmid': '26468213', 'type': 'RESULT', 'citation': 'Rasmussen OW, Lauszus FF, Loekke M. Telemedicine compared with standard care in type 2 diabetes mellitus: A randomized trial in an outpatient clinic. J Telemed Telecare. 2016 Sep;22(6):363-8. doi: 10.1177/1357633X15608984. Epub 2015 Oct 14.'}, {'pmid': '30609983', 'type': 'RESULT', 'citation': 'Sun C, Sun L, Xi S, Zhang H, Wang H, Feng Y, Deng Y, Wang H, Xiao X, Wang G, Gao Y, Wang G. Mobile Phone-Based Telemedicine Practice in Older Chinese Patients with Type 2 Diabetes Mellitus: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 4;7(1):e10664. doi: 10.2196/10664.'}, {'pmid': '23171659', 'type': 'RESULT', 'citation': 'Tang PC, Overhage JM, Chan AS, Brown NL, Aghighi B, Entwistle MP, Hui SL, Hyde SM, Klieman LH, Mitchell CJ, Perkins AJ, Qureshi LS, Waltimyer TA, Winters LJ, Young CY. Online disease management of diabetes: engaging and motivating patients online with enhanced resources-diabetes (EMPOWER-D), a randomized controlled trial. J Am Med Inform Assoc. 2013 May 1;20(3):526-34. doi: 10.1136/amiajnl-2012-001263. Epub 2012 Nov 20.'}]}, 'descriptionModule': {'briefSummary': "The goal of this randomised control type of study is to examine the effects of Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones on self-care and metabolic control.\n\nThe Hypotheses of the Study:\n\nH1: Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones has a positive impact on individuals' self-care.\n\nH2: Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones has a positive impact on individuals' metabolic control variables.\n\nParticipants will answer the data collection tools in the first and second interviews and metabolic control variables will be record. Diabetes training videos will sent to the Training Group through smartphones after the first meeting as two episodes a week.\n\nVideo Diabetes Training given to training group will be examine the effects of on self-care and metabolic control.", 'detailedDescription': 'The study will conduct to examine the effects of Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones on self-care and metabolic control.\n\nThis experimental, randomized, and controlled study will conduct with a total of 112 individuals with Type 2 Diabetes (56 in the Training Group, and 56 in the Control Group), who apply to the Internal Medicine Clinic of a state hospital in the Mediterranean Region of Turkey between February and August 2022, who volunteered to participate in the study and met the inclusion criteria.\n\nA total of 112 individuals with Type 2 Diabetes, who volunteered to participate in the study, and met the inclusion criteria, will select with the Simple Random Sampling Method and will randomize with the help of a computer program.\n\nParticipants will answer the data collection tools in the first and second interviews and metabolic control variables will be record. Diabetes training videos will sent to the Training Group through smartphones after the first meeting as two episodes a week.\n\nVideo Diabetes Training given to training group will be examine the effects of on self-care and metabolic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* agreed to participate in the study voluntarily,\n* were diagnosed with Type 2 Diabetes for at least 6 months,\n* were 18 years of age or older,\n* were literate, had smartphones with video playback features and internet,\n* without a physician diagnosis that would prevent communication, and psychiatric problems and hearing problems\n* those who did not have sensory losses such as vision or hearing.\n\nExclusion Criteria:\n\n-Individuals who did not meet the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT06178094', 'briefTitle': 'The Effects of Video Training Given to Individuals With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Kırklareli University'}, 'officialTitle': 'The Effects of Video Training Given to Individuals With Type 2 Diabetes Through Smartphones on Self-Care and Metabolic Control', 'orgStudyIdInfo': {'id': 'E-69456409-199-35238'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video Diabetes Training group', 'description': 'The data collection tools will apply in the first and second interviews and metabolic control variables will record.\n\nDiabetes training videos will sent to the Training Group through smartphones after the first meeting as two episodes a week.', 'interventionNames': ['Behavioral: Video Training']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'The data collection tools will apply in the first and second interviews and metabolic control variables will record.'}], 'interventions': [{'name': 'Video Training', 'type': 'BEHAVIORAL', 'description': 'The participants in the Training Group is to sent a total of eight episodes of the Diabetes Training Videos prepare by the researcher, twice a week, through smartphones after the first interview', 'armGroupLabels': ['Video Diabetes Training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39100', 'city': 'Kırklareli', 'country': 'Turkey (Türkiye)', 'facility': 'Kırklareli University', 'geoPoint': {'lat': 41.73508, 'lon': 27.22521}}], 'overallOfficials': [{'name': 'İlknur METİN AKTEN, PhD,MSc,RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kırklareli University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kırklareli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'İlknur METİN AKTEN', 'investigatorAffiliation': 'Kırklareli University'}}}}