Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT05473494
Status:
UNKNOWN
Last Update Posted:
2022-07-26
First Post:
2022-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THE EFFECT OF ONLINE TRAINING ON FOOT CARE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012681', 'term': 'Sensitivity Training Groups'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}, {'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetic Foot Care Self-Efficacy Scale', 'timeFrame': 'nine weeks', 'description': 'Self-efficacy is measured by scoring between 0 and 10. The 9 expressions that make up the scale are evaluated on the 11-digit visual scale, which is specified as -Not sure=0 and very sure=10. The lowest score of the scale is 0 and the highest score is 100. As the score obtained from the scale increases, the diabetic foot self-efficacy level increases in parallel.'}], 'secondaryOutcomes': [{'measure': 'Foot Care Behavıor Scale', 'timeFrame': 'nine weeks', 'description': "Consisting of 15 items in a 5-point Likert type, the scale is scored according to agree-disagree (1= Never, 2= Occasionally, 3= Sometimes, 4= Often, and 5= Always) and consists of 15 items. The lowest score that can be obtained from the scale, which evaluates foot care behavior as a single dimension, is 15 and the highest score is 75. An increase in the scale score indicates that the individual's foot self-care behaviors become positive."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type2diabetes', 'DiabeticFootCare', 'OnlineEducational', 'DistanceEducation', 'Self-Effectıveness'], 'conditions': ['Type2diabetes', 'Diabetic Foot']}, 'descriptionModule': {'briefSummary': "The aim of this study is to determine the effect of online trainings on diabetic foot care on foot care behavior and self-efficacy attitudes of individuals with type II diabetes.\n\nPurpose in accordance with the patient's Diagnostic Information Form, diabetic foot care self-efficacy Scale(DABOO), foot care Behavior Scale(ABDO) and diabetic foot risk screening forms are available in the data collection tools; education and Research Hospital Internal Medicine outpatient clinic with Deeply Izmit Seka state hospital, inpatient or outpatient treatment for persons with Type II diabetes who agree to volunteer to participate in research 90 shall apply. After that, the groups will be divided into two groups by randomization, and one of the groups will be given training sessions consisting of min 20 max 40 minutes for diabetic foot care in 5 sessions for nine weeks. After the training, the scales will be applied to the groups again. The data obtained before and after the training will be compared statistically in a computer environment"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who were applied the Dietetic Foot Risk Screening form during the physician's examination and who were in the low and medium risk groups after the physician's examination.\n* To be able to read and write.\n* Being between the ages of 18-65.\n* Being on oral antidiabetic (OAD) and/or insulin therapy.\n* No restriction of access to the Internet.\n* To be able to use the Zoom program or WhatsApp video conversation with or without support.\n* Having computer and/or telephone skills.\n* Volunteering to participate in the study (Informed consent form will be signed by the participants during the application)\n* Not having sensory loss such as speech and hearing that prevents communication and no psychiatric problems.\n\nExclusion Criteria:\n\noutside the inclusion criteria."}, 'identificationModule': {'nctId': 'NCT05473494', 'briefTitle': 'THE EFFECT OF ONLINE TRAINING ON FOOT CARE', 'organization': {'class': 'OTHER', 'fullName': 'Maltepe University'}, 'officialTitle': 'THE EFFECT OF ONLINE TRAININGS ON DIABETIC FOOT CARE ON FOOT CARE BEHAVIOR AND SELF-EFFECTIVENESS ATTITUDES OF INDIVIDUALS WITH TYPE II DIABETES', 'orgStudyIdInfo': {'id': '2021/33-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'training group', 'interventionNames': ['Other: training group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'training group', 'type': 'OTHER', 'description': 'Trainings on diabetic foot care consisting of min 20 max 40 minutes will be given in 5 sessions for nine weeks. Training will be given face to face online.', 'armGroupLabels': ['training group']}, {'name': 'control group', 'type': 'OTHER', 'description': 'Group not to be trained.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41500', 'city': 'Kocaeli', 'state': 'Izmit', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Ev', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'centralContacts': [{'name': 'Ayşegül Kandemir', 'role': 'CONTACT', 'email': 'aysegul.kanfe@hotmail.com', 'phone': '5433837160', 'phoneExt': '+90'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maltepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ayşegül Kandemir', 'investigatorAffiliation': 'Maltepe University'}}}}