Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT04029103
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2019-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of The Effectiveness of m-DAKBAS on Foot Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D001519', 'term': 'Behavior'}], '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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2019-06-26', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge', 'timeFrame': 'before the intervention- Immediately after the intervention', 'description': "Diabetic Foot Knowledge Form (DFKF) included 20 questions that aim to measure the knowledge level of individuals with diabetes about diabetic foot and foot care. The questions had three options (True, False, I don't know). Each correct answer was scored 1 point. Higher scores indicate higher knowledge levels"}, {'measure': 'Behaviour', 'timeFrame': 'before the intervention- Immediately after the intervention', 'description': 'Foot Self Care Behaviours Scale is composed of 15 items which were assessed as 1=Never, 2=Rarely, 3=Sometimes, 4=Frequently, 5=Always). Scores range between 15 and 75. Higher scores indicate better self care behaviours'}, {'measure': 'self-efficacy', 'timeFrame': 'before the intervention- Immediately after the intervention', 'description': 'Diabetic Foot Care Self Efficacy Scale has nine items which are rated on an 11-item visual scale that range from 0=I find it totally insufficient and 10= I find it totally sufficient. Scores to be obtained from the scale range between 0 and 90. Higher scores indicate higher self-efficacy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic foot', 'health technology', 'mobile application'], 'conditions': ['Diabetic Foot', 'Foot Ulcer, Diabetic', 'Health Knowledge, Attitudes, Practice']}, 'descriptionModule': {'briefSummary': 'Aim: To develop the Mobile Diabetic Foot Personal Care System (m-DAKBAS) related to foot care for diabetic individuals and to evaluate its effectiveness.\n\nMethod: The study involved 88 patients who applied to the Diabetes Polyclinic (intervention=44; control=44). While the intervention group used m-DAKBAS (for 6 months), the control group was provided with a verbal foot care training once, as a standardized procedure of the hospital. Data were collected using the "Socio-demographic Form", "Diabetic Foot Knowledge Form - DFKF", "Foot Self Care Behaviours Scale -FSCBS", "Diabetic Foot Care Self Efficacy Scale - DFCSES", and "m-DAKBAS Assessment Form".', 'detailedDescription': "Diabetic foot, one of the important complications of diabetes, is a health problem that affects quality of life in a negative way, that has high treatment and care costs and mortality rates, long hospitalization duration and thus with all these aspects a psychological, physical, social and economic priority. Despite all these, diabetic foot complications and amputations could be decreased with the help of a good foot care, education and a multidisciplinary team work. Mobile technologies have been continuously increasing worldwide for the management of diabetes, and the use of these technologies is recommended by international institutions as well.\n\nTherefore, the purpose of this study is to develop a Turkish mobile application that would increase patients' knowledge levels about foot health and care, improve their behaviours and self-efficacy, and evaluate its effectiveness so that it could be possible to prevent foot ulcer and the related amputations in individuals with diabetes. The Mobile Diabetic Foot Personal Care System (m-DAKBAS) developed for this purpose enables to increase individuals' self-confidence, improve communication with the health personnel, involve patients in their own care in an interactive way, and take responsibility.\n\nThe usability of the application was indicated by the patients' feedback, and in line with the purpose of the mobile application, improvements in the patients' knowledge, behaviours and self-efficacy about foot care in diabetes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having a diagnosis history of \\>1 year;\n* having Type 1 or Type 2 diabetes;\n* having a mobile phone with Android or IOS operating system;\n\nExclusion Criteria:\n\n* having visual impairment,\n* hand skill problem, difficulty in communication, or mental insufficiency;\n* currently having foot ulcer.'}, 'identificationModule': {'nctId': 'NCT04029103', 'briefTitle': 'Evaluation of The Effectiveness of m-DAKBAS on Foot Care', 'organization': {'class': 'OTHER', 'fullName': 'Sanko University'}, 'officialTitle': 'Evaluation of The Effectiveness of Mobile Diabetic Foot Personal Care System (m-DAKBAS) in Diabetic Individuals', 'orgStudyIdInfo': {'id': 'SankoM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'used m-DAKBAS', 'description': "m-DAKBAS application was downloaded to the mobile phones of the participants who met the research criteria and accepted to participate in the study; the participants were given a username and a password for the confidentiality. They were instructed how to use the application after a number of trials.\n\nThe participants were asked to send their blood sugar levels each time they measured it and foot observations daily through the application. Using the admin panel, the researcher followed the participants' frequency of using the application and the data they sent throughout 24 weeks and tried to find solutions to the problems experienced (for example: hyperglycaemia, insulin dosage adjustments). The participants were provided with feedback in line with these data; SMS reminders were sent if the tasks were not completed.", 'interventionNames': ['Other: knowledge, behaviour, self efficacy']}, {'type': 'EXPERIMENTAL', 'label': 'not used m-DAKBAS', 'description': 'The participants who met the research criteria and accepted to participate in the study were given training via verbal instruction about the information in the content of m-DAKBAS (definition of Diabetic Foot, risk factors, protective precautions, daily foot care)', 'interventionNames': ['Other: knowledge, behaviour, self efficacy']}], 'interventions': [{'name': 'knowledge, behaviour, self efficacy', 'type': 'OTHER', 'description': 'Knowledge, behavior and self-efficacy of both groups were measured before and after the study.', 'armGroupLabels': ['not used m-DAKBAS', 'used m-DAKBAS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Şehitkamil', 'country': 'Turkey (Türkiye)', 'facility': 'SANKO University', 'geoPoint': {'lat': 37.07962, 'lon': 37.38003}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after research published', 'ipdSharing': 'YES', 'description': 'the article has been sent to the journal for publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanko University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Koç University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}