Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-20 @ 7:48 PM
Study NCT ID:
NCT04265469
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2020-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Application For Educating Diabetics About 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'their self-efficacy', 'timeFrame': 'change from baseline self efficiancy at week 4.', 'description': 'Diabetic Foot Care Self-efficacy Scale is a scale that determines a diabetic individual\'s perception of self-efficacy with respect to executing diabetic foot care activities. Responses to this nine-item 10-point Likert-type of questionnaire are assessed on a visual scale that ranges from "I\'m absolutely unsure=0" to "I\'m very sure=10". The lowest possible score on the scale is 0; the highest is 100.'}, {'measure': 'Diabetes Foot Knowledge', 'timeFrame': 'change from baseline Diabetes Foot Knowledge at week 4.', 'description': 'Diabetes Foot Knowledge Questionnaire (DFKQ) were developed by Garcia et al. as a 5-item instrument that assesses the level of knowledge patients have about foot care. The questionnaire is evaluated on the basis of the total score. An increase in the score indicates that the diabetic individual has an increased level of knowledge about foot care'}, {'measure': 'Foot Self-care Behavior', 'timeFrame': 'change from baseline Foot Self-care Behavior at week 4.', 'description': 'Foot Self-care Behavior Scale assesses self-efficacy behavior in the context of foot care. It is a 16-item 5-point Likert-type of scale in which responses are assessed as "I do this: 1=Never, 2=Occasionally, 3=Sometimes, 4=Frequently, 5=Always." The lowest possible score on the scale is 16; the highest is 80'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic foot, mobile application, patient education'], 'conditions': ['Diabetic Foot, Mobile Application, Patient Education']}, 'descriptionModule': {'briefSummary': "Purpose: Our aim was to develop a training program on the mobile application and to assess the effect of this training on the participants' knowledge about foot care, their self-efficacy and their behavior levels.", 'detailedDescription': 'The universe of this randomized controlled study consisted of 130 patients who had presented to a training and research hospital in Istanbul. The data were collected during the period March-September 2017 with an Information Form, the Diabetic Foot Knowledge Scale, Diabetic Foot Care Self-efficacy Scale, Foot Self-care Behavior Scale and a Feedback Form on the Mobile Application Training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed as a Type 2 diabetic according to ADA criteria at least six months prior to the study,\n* being 18 years of age and over,\n* being literate and fluent in Turkish,\n* not having an active foot ulcer,\n* owning and being able to operate a smart phone,\n* not having any communication or mental problems,\n* consenting to participating in the research.\n\nExclusion Criteria:\n\n* Patients with advanced retinopathy and those wishing to withdraw from the research were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04265469', 'briefTitle': 'Mobile Application For Educating Diabetics About Foot Care', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medeniyet University'}, 'officialTitle': 'The Effect of Mobile Application in Foot Care of Type 2 Diabetes Patients: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '42432568'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with diabetics get mobile education', 'description': 'Patients with diabetics get mobile education', 'interventionNames': ['Other: Diabetic foot education']}, {'type': 'NO_INTERVENTION', 'label': 'Patients with diabetics', 'description': 'Patients with diabetics'}], 'interventions': [{'name': 'Diabetic foot education', 'type': 'OTHER', 'description': 'Give Diabetic foot education via mobile phone', 'armGroupLabels': ['Patients with diabetics get mobile education']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medeniyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Berna Dincer', 'investigatorAffiliation': 'Istanbul Medeniyet University'}}}}