Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 1:29 AM
Study NCT ID:
NCT01387633
Status:
UNKNOWN
Last Update Posted:
2011-07-04
First Post:
2011-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Educational Intervention and Social Support in Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-12-02', 'releaseDate': '2015-10-29'}, {'resetDate': '2024-08-16', 'releaseDate': '2024-03-11'}], 'estimatedResultsFirstSubmitDate': '2015-10-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D010349', 'term': 'Patient Compliance'}], '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'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2011-07-01', 'studyFirstSubmitDate': '2011-06-16', 'studyFirstSubmitQcDate': '2011-07-01', 'lastUpdatePostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glycated hemoglobin', 'timeFrame': '21 mounths'}, {'measure': 'fasting plasma glucose', 'timeFrame': '21 mounths'}, {'measure': 'triglycerides', 'timeFrame': '21 mounths'}, {'measure': 'total cholesterol and fractions', 'timeFrame': '21 mounths'}, {'measure': 'microalbuminuria', 'timeFrame': '21 mounths'}, {'measure': 'urea', 'timeFrame': '21 mounths'}, {'measure': 'creatinine', 'timeFrame': '21 mounths'}, {'measure': 'body mass index', 'timeFrame': '21 mounths'}, {'measure': 'waist circumference', 'timeFrame': '21 mounths'}, {'measure': 'blood pressure', 'timeFrame': '21 mounths'}], 'secondaryOutcomes': [{'measure': 'Perceived Self-Efficacy: Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus', 'timeFrame': '21 mounths'}, {'measure': 'Knowledge about diabetes mellitus: Diabetes Mellitus knowledge (DKN-A)', 'timeFrame': '21 mounths'}, {'measure': 'Adherence to medication treatment: Self-Reported Measure of Medication Adherence (Measure of Treatment Adherence - MTA)', 'timeFrame': '21 mounths'}, {'measure': 'Adherence to self care: Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) ( Diabetes Self-Care Activities Questionnaire)', 'timeFrame': '21 mounths'}, {'measure': 'Perception of stress: Perceived Stress Scale (Perceived Stress Scale)', 'timeFrame': '21 mounths'}, {'measure': 'Ways of coping: Ways of Coping Scale (Ways of Coping Scale)', 'timeFrame': '21 mounths'}, {'measure': 'Acceptance of Illness (Acceptance of Illness Scale)', 'timeFrame': '21 mounths'}, {'measure': 'Perception of social support: The Social Support Network Inventory', 'timeFrame': '21 mounths'}, {'measure': 'Self-monitoring of blood glucose', 'timeFrame': '21 mounths'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nursing care', 'Diabetes mellitus', 'Health Education', 'Patient compliance', 'Social support', 'Self-efficacy', 'Adaptation strategy'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of an educational program for people with diabetes mellitus based on the family social support.', 'detailedDescription': "H0: The person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions hasn't greater glycemic control.\n\nHA: The person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions has greater glycemic control."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with DM2\n* Both sexes\n* Minimum age of 40 years\n* Able to dialogue\n* Lack of complications in advanced\n\nExclusion Criteria:\n\n* Hemodialysis treatment\n* Amaurosis\n* Sequelae of Stroke and/or Heart Failure\n* Previous amputations at any level of the lower limb\n* Active ulcer in the lower limbs\n* People in wheelchairs and/or litter\n* People with limited understanding of the instruments due to cultural factors'}, 'identificationModule': {'nctId': 'NCT01387633', 'briefTitle': 'Educational Intervention and Social Support in Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'orgStudyIdInfo': {'id': 'diabetes2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational intervention through telephone contact', 'description': 'Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact', 'interventionNames': ['Other: Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational intervention group', 'description': 'Educational intervention group for people with diabetes through Diabetes Conversation Maps.', 'interventionNames': ['Other: Educational intervention group for people with diabetes through Diabetes Conversation Maps']}], 'interventions': [{'name': 'Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact', 'type': 'OTHER', 'description': 'For family members/caregivers: telephone contacts will be conducted in day and time which family member/caregiver prefers, and he/she may make collect calls to the researcher always he/she judges it necessary during the period of study. Phone contacts will be recorded to ensure the registration of orientation given, using a digital phone recorder PCTEL. And they will be arranged with the technique of motivational interviewing that includes the skills to ask, listen and inform. For this, protocols based on these skills, which the covered topics will be those worked in group sessions through Diabetes Conversation Maps. Voice quality related to the tone, volume and clarity as well as the skills and strategies to listen to the interviews will be worked under the guidance of an audiologist', 'armGroupLabels': ['Educational intervention through telephone contact']}, {'name': 'Educational intervention group for people with diabetes through Diabetes Conversation Maps', 'type': 'OTHER', 'description': 'For people with diabetes mellitus: educational interventions will be conducted in accordance with the assumptions of the Social Cognitive Theory, through Diabetes Conversation Maps , whose use is consistent with this theory (ADA, 2007). Diabetes Conversation Maps are a tool which involves people in the learning process about the disease, to make them able to process information more effectively and use them in making daily decisions in the management of diabetes mellitus (DM). It is recommended that this tool is used in small groups of three to ten people, in order to provide dynamic discussions among the participants (ADA, 2007). Currently, the maps that cover the following learning contexts: How the Body and Diabetes Work, Healthy Eating and Physical Activity, and Medication Treatment and Monitoring of Blood Glucose; Achieving the Goals with the Insulin and Weather Map of Diabetic Foot are available for the Brazilian Portuguese language.', 'armGroupLabels': ['Educational intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Ana Emilia Pace, Principal Investigator', 'role': 'CONTACT', 'email': 'aepace@eerp.usp.br', 'phone': '(55) 16 3602-3401'}, {'name': 'Ana Emilia Pace, Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'centralContacts': [{'name': 'Ana Emilia Pace, Principal Investigator', 'role': 'CONTACT', 'email': 'aepace@eerp.usp.br', 'phone': '(55) 16 3603-3401'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'University of São Paulo', 'oldOrganization': 'University of Sao Paulo at Ribeirão Preto College of Nursing'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-10-29', 'type': 'RELEASE'}, {'date': '2015-12-02', 'type': 'RESET'}, {'date': '2024-03-11', 'type': 'RELEASE'}, {'date': '2024-08-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ana Emilia Pace, Professor, University of Sao Paulo'}}}}