Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-07 @ 11:18 PM
Study NCT ID:
NCT04191902
Status:
UNKNOWN
Last Update Posted:
2020-11-06
First Post:
2019-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2019-11-28', 'studyFirstSubmitQcDate': '2019-12-07', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'differences in glycemic control', 'timeFrame': '1 year', 'description': 'Evaluation of the glycemic indices'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Educational Problems']}, 'descriptionModule': {'briefSummary': 'The investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group.', 'detailedDescription': 'Patients with diabetes mellitus (DM) have greater control over the disease when they acquire some knowledge about it. In this context, the use of technology by health professionals for nutritional guidance and self-care has shown promising results. This study aims to evaluate the impact of these educational approaches via SMS on glycemic control of patients with DM, followed at the Endocrinology Outpatient Clinic of the Antonio Pedro University Hospital (HUAP). Also, the investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group. The patients in the intervention group received weekly SMS for six months, with dietary guidelines and DM care. Both groups answered a questionnaire at the beginning and end of the intervention, which consisted of assessing satisfaction with the health service received and their care for DM. Similarly, the investigators collected their clinical and laboratory data from medical records at the beginning and end of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all patients from the ward', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetes\n\nExclusion Criteria:\n\n* non diabetes'}, 'identificationModule': {'nctId': 'NCT04191902', 'acronym': 'SMS', 'briefTitle': 'Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal Fluminense'}, 'officialTitle': 'Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus: A Brazilian Case Study', 'orgStudyIdInfo': {'id': 'Diabetes Mellitus'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'control'}, {'label': '2', 'description': 'treated', 'interventionNames': ['Behavioral: orientation']}], 'interventions': [{'name': 'orientation', 'type': 'BEHAVIORAL', 'description': 'patients will be oriented', 'armGroupLabels': ['2']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'none information will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal Fluminense', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Giselle Taboada', 'investigatorAffiliation': 'Universidade Federal Fluminense'}}}}