Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-01 @ 5:13 PM
Study NCT ID:
NCT04979559
Status:
UNKNOWN
Last Update Posted:
2021-07-28
First Post:
2021-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The participant and care provider in each site are unaware of the group allocation.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be assigned to one of two arms: (1) a group that is used mobile health application intervention for screening and early intervention and (2) a group that receive standard care for screening and early intervention from PHCs regular practice.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-22', 'studyFirstSubmitDate': '2021-06-20', 'studyFirstSubmitQcDate': '2021-07-22', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Participant's acceptance of mobile health application", 'timeFrame': 'after intervention at 12-weeks', 'description': "evaluation of participant's acceptance to the device using Mobile Health Application Acceptance Questioner adapted from previous study"}], 'primaryOutcomes': [{'measure': 'Body weight mean change from baseline', 'timeFrame': 'at baseline and after intervention at 12-weeks', 'description': "Participants' body weight measured by scales using kilograms (kg) measurement unit"}, {'measure': 'Waist circumference mean change from baseline', 'timeFrame': 'at baseline and after intervention at 12-weeks', 'description': "Participants' waist circumference measured using measuring tape in centimeter (cm) measurement unit"}, {'measure': 'Fasting blood glucose mean change from baseline', 'timeFrame': 'at baseline and after intervention at 12-weeks', 'description': "Participants' fasting blood glucose measured from vein blood in milligram per deciliter (mg/dL) measurement unit"}, {'measure': 'Hemoglobin A1c mean change from baseline', 'timeFrame': 'at baseline and after intervention at 12-weeks', 'description': "Participants' Hemoglobin A1c measured from vein blood in percent"}, {'measure': 'Oral glucose tolerance test mean change from baseline', 'timeFrame': 'at baseline and after intervention at 12-weeks', 'description': "Participants' oral glucose tolerance test measured from vein blood in milligram per deciliter (mg/dL) measurement unit"}], 'secondaryOutcomes': [{'measure': 'Area under the curve of screening instrument compared to American Diabetes Association criteria', 'timeFrame': 'immediately after the intervention begin', 'description': 'screening accuracy of the instrument reported using graph'}, {'measure': 'Sensitivity value of screening instrument compared to American Diabetes Association criteria', 'timeFrame': 'immediately after the intervention begin', 'description': 'Sensitivity value of the instrument calculated using formula derived from 2x2 tables of diagnostic test'}, {'measure': 'Specificity value of screening instrument compared to American Diabetes Association criteria', 'timeFrame': 'immediately after the intervention begin', 'description': 'Specificity value of the instrument calculated using formula derived from 2x2 tables of diagnostic test'}, {'measure': 'Positive predictive value of screening instrument compared to American Diabetes Association criteria', 'timeFrame': 'immediately after the intervention begin', 'description': 'Positive predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test'}, {'measure': 'Negative predictive value of screening instrument compared to American Diabetes Association criteria', 'timeFrame': 'immediately after the intervention begin', 'description': 'Negative predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test'}, {'measure': 'Accuracy value of screening instrument compared to American Diabetes Association criteria', 'timeFrame': 'immediately after the intervention begin', 'description': 'Accuracy predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test'}, {'measure': 'Likelihood ratio of screening instrument compared to American Diabetes Association criteria', 'timeFrame': 'immediately after the intervention begin', 'description': 'Likelihood ratio of the instrument calculated using formula derived from 2x2 tables of diagnostic test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemedicine', 'Intervention', 'Screening', 'Self Care', 'Primary Health Care'], 'conditions': ['PreDiabetes', 'Prediabetic State']}, 'descriptionModule': {'briefSummary': 'Background: Preventing type-2 diabetes mellitus begins with early screening and intervention of prediabetic participants. Until now, prediabetes screening and early intervention have not been optimal. The rapid advancement of technology, as well as its increased use, may provide an opportunity to improve the quality and cost of healthcare services. It is quite practicable to investigate and implement a valid, practical and easy-to-use mobile health application for participants and health staffs in screening and early intervention of prediabetes participants at primary health cares setting. This protocol aimed to identify and develop a valid, practical, and easy-to-use mobile health application for screening and early intervention of prediabetes participants at primary health cares.\n\nMethods: This protocol was prepared in accordance with the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This is a mixed-methods study with sequential exploratory approach. This project will begin with in-depth interview to gather qualitative information regarding mobile health application necessity for prediabetes participants at the primary health cares. The impact of the usage will be studied quantitatively using randomized controlled trial. Prediabetic participants and primary health cares staffs at Yogyakarta province will be the research subjects. The collected findings will be examined based on the type of the data.\n\nDiscussion: The proposed research aimed to obtain information and trial results regarding mobile health application usage for prediabetes participants screening and early intervention at primary health cares setting.', 'detailedDescription': 'The goal of this study is to create a mobile health application for prediabetes patients that included screening and early intervention in Primary Health Cares (PHCs) setting. More specifically, the objectives are as follows:\n\n1. To portray regular prediabetes screening and early intervention practice in PHCs.\n2. To assess prediabetes screening and early intervention data necessity for mobile health application model at PHCs.\n3. To assess the feasibility of mobile health application usage for screening and early intervention of prediabetes patients at PHCs.\n4. To assess internal and external factors that influence the intention-to-use, easiness, and usefulness of mobile health applications for prediabetes patients and health staff.\n5. To assess the impact of early intervention using mobile health applications on prediabetes patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed as the prediabetic state using American Diabetes Association (ADA) criteria\n* have no previous diagnosis of type 2 diabetes or history of taking anti-hyperglycemic drugs\n* have access to and able to use a personal smartphone\n* willing to undertake study activities and written informed consent\n\nExclusion Criteria:\n\n* severe medical condition\n* disability to perform physical activity'}, 'identificationModule': {'nctId': 'NCT04979559', 'briefTitle': 'Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting', 'organization': {'class': 'OTHER', 'fullName': 'Gadjah Mada University'}, 'officialTitle': 'Development Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting: Protocol of a Pilot Study', 'orgStudyIdInfo': {'id': 'KE/FK/1375/EC/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mHealth apps', 'description': 'The participants in this arm will receive information regarding mobile health applications used for screening and early intervention of the prediabetic states.', 'interventionNames': ['Device: Mobile health apps']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'The participant in this arm will receive regular practice or standard care of screening and early intervention of prediabetic state.', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'Mobile health apps', 'type': 'DEVICE', 'description': 'Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion', 'armGroupLabels': ['mHealth apps']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Regular practice for screening and early intervention for prediabetes patient in primary health cares setting', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55571', 'city': 'Sleman', 'state': 'Special Region of Yogyakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Yaltafit A Jeem', 'role': 'CONTACT', 'email': 'yaltafit.abror.j@ugm.ac.id', 'phone': '+62 856-4366-1294'}], 'facility': 'Kalasan PHC', 'geoPoint': {'lat': -7.71556, 'lon': 110.35556}}], 'centralContacts': [{'name': 'Yaltafit A Jeem', 'role': 'CONTACT', 'email': 'yaltafit.abror.j@ugm.ac.id', 'phone': '+62 856-4366-1294'}, {'name': 'Russy N Andriani', 'role': 'CONTACT', 'email': 'russy.novita@gmail.com', 'phone': '+6287821562151'}], 'overallOfficials': [{'name': 'Yaltafit A Jeem', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gadjah Mada University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gadjah Mada University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitas Islam Indonesia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Yaltafit Abror Jeem', 'investigatorAffiliation': 'Gadjah Mada University'}}}}