Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT02868320
Status:
COMPLETED
Last Update Posted:
2016-08-16
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMS Technology for the Promotion of Diabetes Education and Self-Management in Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-11', 'studyFirstSubmitDate': '2016-08-09', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in HbA1c', 'timeFrame': 'baseline and 12 weeks', 'description': 'measured by the difference between endpoint and baseline values and by the number of patients who experienced a reduction of at least 1% from baseline to endpoint'}], 'secondaryOutcomes': [{'measure': 'blood glucose levels', 'timeFrame': '12 weeks'}, {'measure': 'body weight', 'timeFrame': '12 weeks'}, {'measure': 'Treatment adherence', 'timeFrame': '12 weeks', 'description': 'measured by the diabetes self-care inventory (SCI)'}, {'measure': 'Medication adherence', 'timeFrame': '12 weeks', 'description': 'measured by the Morisky medication adherence scale (MMAS-4)'}, {'measure': 'Diabetes self-efficacy', 'timeFrame': '12 weeks', 'description': 'measured by the diabetes empowerment scale short form (DES-SF)'}, {'measure': 'Frequency of blood glucose measurement', 'timeFrame': '12 weeks'}, {'measure': 'Rate of hospital/ER admissions', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['SMS', 'text messaging', 'diabetes self management', 'glycemic control', 'mHealth', 'mobile health', 'diabetes education'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '29258499', 'type': 'DERIVED', 'citation': 'Abaza H, Marschollek M. SMS education for the promotion of diabetes self-management in low & middle income countries: a pilot randomized controlled trial in Egypt. BMC Public Health. 2017 Dec 19;17(1):962. doi: 10.1186/s12889-017-4973-5.'}]}, 'descriptionModule': {'briefSummary': 'This study was conducted at the teaching hospital of Misr University for Science \\& Technology. It aimed to examine the use of SMS technology in educating and monitoring diabetic patients in Egypt, and assess the impact of educational text messages on their glycemic control and self-management behaviors. Participants were randomized into an intervention and a control group. Intervention patients received an instruction booklet as well as daily educational and weekly reminder messages to better control their diabetes. Control patients received the same instruction booklet but no SMS messages. Both group patients took an HbA1c test at the beginning and end of the study period and were asked to measure their blood glucose once a week and record their readings into a monitoring table over 12 weeks. The primary outcome was the change in HbA1c levels, which was expected to be greater among intervention patients at the end of the study. Secondary outcomes included blood glucose levels, treatment and medication adherence, diabetes self-efficacy, rate of hospital/ER visits, frequency of blood glucose measurement, among others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* has diabetes\n* owns a mobile phone\n* can read SMS messages or lives with someone that can read for them.\n\nExclusion Criteria:\n\n* cannot read or not SMS familiar and lives alone'}, 'identificationModule': {'nctId': 'NCT02868320', 'briefTitle': 'SMS Technology for the Promotion of Diabetes Education and Self-Management in Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'SMS Technology for the Promotion of Diabetes Education and Self-Management', 'orgStudyIdInfo': {'id': 'DiabAwPro'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'This group received a diabetes instruction booklet in addition to daily educational SMS messages and weekly reminders', 'interventionNames': ['Other: SMS messages', 'Other: Instruction booklet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'This group only received a diabetes instruction booklet', 'interventionNames': ['Other: Instruction booklet']}], 'interventions': [{'name': 'SMS messages', 'type': 'OTHER', 'description': 'Daily educational messages addressing the following categories: diet, exercise, complications, medications, foot care, blood sugar testing, and hypo- and hyperglycemia.\n\nWeekly reminder messages of blood glucose testing.', 'armGroupLabels': ['Intervention group']}, {'name': 'Instruction booklet', 'type': 'OTHER', 'description': 'General detailed instructions addressing the same SMS categories.', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12566', 'city': 'Giza', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Misr University for Science & Technology (MUST) hospital'}], 'overallOfficials': [{'name': 'Haitham Abaza', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PLRI Institute for Medical Informatics, Hannover Medical School'}, {'name': 'Michael Marschollek', 'role': 'STUDY_DIRECTOR', 'affiliation': 'PLRI Institute for Medical Informatics, Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Misr University for Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral candidate at PLRI Institute for Medical Informatics', 'investigatorFullName': 'Haitham Abaza', 'investigatorAffiliation': 'Hannover Medical School'}}}}