Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-02-01 @ 11:35 AM
Study NCT ID:
NCT03167866
Status:
UNKNOWN
Last Update Posted:
2017-05-30
First Post:
2017-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Motivation Text Messages on Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Randomization will be by study personell that is not in contact with participants'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-24', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-05-24', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c levels at 6 months from beginning of messages', 'timeFrame': 'at 6 months from beginning of study', 'description': 'Blood HbA1c levels are reflective of how well diabetes is controlled'}], 'secondaryOutcomes': [{'measure': 'Diabetes Quality of Life questionnaire', 'timeFrame': 'at 6 months from beginning of study', 'description': 'To design and test the reliability and validity of a brief treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '24505864', 'type': 'BACKGROUND', 'citation': 'Text message program improves outcomes, decreases ED utilization among ED patients with poorly controlled diabetes. ED Manag. 2014 Feb;26(2):20-3.'}, {'pmid': '22730940', 'type': 'BACKGROUND', 'citation': 'Reinhardt JA, van der Ploeg HP, Grzegrzulka R, Timperley JG. lmplementing lifestyle change through phone-based motivational interviewing in rural-based women with previous gestational diabetes mellitus. Health Promot J Austr. 2012 Apr;23(1):5-9. doi: 10.1071/he12005.'}, {'pmid': '22524591', 'type': 'BACKGROUND', 'citation': 'Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.'}, {'pmid': '26822328', 'type': 'BACKGROUND', 'citation': 'Hochberg I, Feraru G, Kozdoba M, Mannor S, Tennenholtz M, Yom-Tov E. Encouraging Physical Activity in Patients With Diabetes Through Automatic Personalized Feedback via Reinforcement Learning Improves Glycemic Control. Diabetes Care. 2016 Apr;39(4):e59-60. doi: 10.2337/dc15-2340. Epub 2016 Jan 28. No abstract available.'}, {'pmid': '24622367', 'type': 'BACKGROUND', 'citation': 'Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, Shetty AS, Godsland IF, Chaturvedi N, Majeed A, Oliver N, Toumazou C, Alberti KG, Johnston DG. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. doi: 10.1016/S2213-8587(13)70067-6. Epub 2013 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. Participants will be randomized to two groups, the control group gets informational text message and the intervention group gets motivational SMS. The patients get a weekly text message and after 26 weeks the HbA1c and quality of life will be assessed.', 'detailedDescription': 'The investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. Participants will provide demographic and clinical information, fill human value questionnaires and quality of life questionnaires and decide on personal lifestyle-improvement goals. They will then be randomized to one of two groups: the control group gets informational text message and the intervention group gets motivational text message. The patients get a weekly text message and after 26 weeks we will check the HbA1c and quality of life. The text message will be personalized by including personal details acquired by a questionnaire. They will provide demographic and clinical information.\n\nIn addition, the influence of demographic characters and related DM character on the benefit of the motivational SMS will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uncontrolled DM 2 patients (HbA1c \\> 8%)\n* Know to read (Hebrew or Arabic)\n* Have a cellular phone\n* Can sign informed consent.\n\nExclusion Criteria:\n\n* A life expectancy of less than one year'}, 'identificationModule': {'nctId': 'NCT03167866', 'briefTitle': 'Effect of Motivation Text Messages on Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Influence of Motivational Text Messages on Glycemic Control and Healthy Lifestyle Choices in Patients With Diabetes', 'orgStudyIdInfo': {'id': '66666'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'DM patients who receive a weekly informational Short Message Service (SMS) by phone for 26 weeks. informational SMS', 'interventionNames': ['Behavioral: informational SMS']}, {'type': 'EXPERIMENTAL', 'label': 'test group', 'description': 'DM patients who receive a weekly motivational Short Message Service (SMS) for 26 weeks. motivational SMS', 'interventionNames': ['Behavioral: motivational SMS']}], 'interventions': [{'name': 'motivational SMS', 'type': 'BEHAVIORAL', 'description': 'the participant receives a weekly text message that is aimed to increase motivation', 'armGroupLabels': ['test group']}, {'name': 'informational SMS', 'type': 'BEHAVIORAL', 'description': 'the participant a weekly text message that is provides information on improving lifestyle', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Irit Hochberg, MD/PhD', 'role': 'CONTACT', 'email': 'i_hochberg@rambam.health.gov.il', 'phone': '972-4-7772150'}], 'overallOfficials': [{'name': 'Irit Hochberg, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Healthcare Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}