Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-08 @ 3:42 PM
Study NCT ID:
NCT03168633
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Advises Sent Via Email in Attempt of Improving A1C in DM2 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D055118', 'term': 'Medication Adherence'}], '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'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-24', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-05-24', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1C values of patients after 6 months', 'timeFrame': '6 months follow up', 'description': 'HbA1C values'}], 'secondaryOutcomes': [{'measure': 'percentage of messages opened and read', 'timeFrame': '10-12 messages in 6 months', 'description': 'reading of each message will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': [': Type 2 Diabetes Mellitus', 'Web-based intervention', 'medication adherence', 'lifestyle changes'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': "Diabetic patients need to manage their glucose level, physical activity and food intake to successfully cope with their disease. Previous work has shown that reminders of the disease, be they informational or about ones' condition, can improve management of disease in diabetes.\n\nThis trial focuses on delivering these reminders, via email, in attempt to improve the patients glycemic control (measured in Hemoglobin A1C)", 'detailedDescription': "The study initially included 50 patients (men and women, over 18 years of age) who were prior diagnosed with DM2 and unbalanced in their glycemic values (HbA1c above 7%). The patient were sent via email , once every other week, a link to web-based pages which provides information on changing DM2 related such as general DM2 information, the importance of keeping a well-balanced diet, benefits of exercising regularly, drug related information and more.\n\nFurthermore, the patients were sent a questionnaire every other week which they were asked to actively reply to.\n\nEach participating patient was monitored for 6 months, during this time he/she was sent 12 web-based information pages.\n\nDuring the course of the study, information regarding the patients' glycemic control (in the form of HgA1c levels) was collected.\n\nAdditional variables (age, sex, BMI, time passed since diagnosed with DM2) were collected and used for statistical comparison."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Previous diabetes specialist follow\n2. Age over 18.\n3. Diagnosis of diabetes type 2.\n4. HbA1c over 7%\n5. Self-admitted less than optimal adherence to physical activity, diet or medications or computer-recorded less than 80% adherence to medication purchase.\n6. Able to read Hebrew\n7. Uses Email account that is actively read at least twice weekly.\n\nExclusion Criteria:\n\n* Patients who did not the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03168633', 'briefTitle': 'Lifestyle Advises Sent Via Email in Attempt of Improving A1C in DM2 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Effects of Reading Information Sent Via Email and Glycemic Control and Compliance to Recommendations Among Patients With Type 2 Diabetes Mellitus -Prospective Research', 'orgStudyIdInfo': {'id': '0456-14-RMB CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients receiving emails', 'description': 'Diagnosed DM2 patients who meet inclusion criteria. the patients will receive emails containing information about DM2 as a method of reminding patients of the importance of adjusting post diagnosis life-style changes.\n\nweb-based DM2 information pages', 'interventionNames': ['Behavioral: web-based DM2 information pages']}], 'interventions': [{'name': 'web-based DM2 information pages', 'type': 'BEHAVIORAL', 'description': 'Each email will include information on one of the following topics:\n\n1. The importance of physical activity\n2. Correct nutrition\n3. The importance of adhering to medication regimens.\n\nEmails will be either positive (e.g., the importance of good nutrition, and what constitutes good nutrition) or negative (e.g., the risks of not adhering to medications).\n\nThe information will be provided by different approaches: medical research results, practical tips, patient testimonies.…', 'armGroupLabels': ['patients receiving emails']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Irit Hochberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}