Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-07 @ 8:12 PM
Study NCT ID:
NCT03202732
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2017-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-05', 'studyFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '15 mounth', 'description': 'Non-inferiority with respect to HbA1c'}], 'secondaryOutcomes': [{'measure': 'General health will be assessed by items from the SF-36 questionnaire', 'timeFrame': '15 mounth', 'description': 'General health will be measured at baseline and after 15 mounth'}, {'measure': 'Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 6 and 9)', 'timeFrame': '15 mounth', 'description': 'Health literacy will be measured at baseline and after 15 months.'}, {'measure': 'Well-being will be assessed by the WHO-5 Well-being Index', 'timeFrame': '15 mounth', 'description': 'Well-being will be measured at baseline and after 15 months.'}, {'measure': 'Patient Activated Measure (PAM)', 'timeFrame': '15 mounth', 'description': 'Patient Activated Measure (PAM) will be measured at baseline and after 15 months.'}, {'measure': '"Generic questions concerning patient involvement" is validate by "DEFACTUM"', 'timeFrame': '15 mounth', 'description': 'Patient involvement will be measured at baseline and after 15 months.'}, {'measure': 'The problem Areas In Diabetes Scale (PAID)', 'timeFrame': '15 mounth', 'description': 'PAID will be measured at baseline and after 15 months.'}, {'measure': 'Blood pressure', 'timeFrame': '15 mounth', 'description': 'Blood pressure will be measured at baseline and after 15 months.'}, {'measure': 'Urine albumine/creatinine ratio', 'timeFrame': '15 mounth', 'description': 'urine albumine/creatinine ratio will be measured at baseline and after 15 months.'}, {'measure': 'Number and type consultations', 'timeFrame': '15 mounth', 'description': 'Consultations consists of face-to-face, telephone, cancel, registered non-attendance and health care professional involved in the consultation will be measured after 15 mounth'}, {'measure': 'Mortality', 'timeFrame': '15 mounth', 'description': 'Mortality will be measured after 15 months.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-management', 'Patient Activeted measure', 'Patient-reported outcome', 'Type 1 diabetes Mellitus', 'Non-inferiority study'], 'conditions': ['Type1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of the use of DiabetesFlex in diabetes care compared to standard care in relation to patient involvement and relevance for specific group of persons with T1DM.\n\nThe investigators hypothesize that the use of DiabetesFlex will lead to a higher degree of patient in-volvement, improved glycaemic control and a decrease in total number of consultations compared to standard care. Furthermore, the investigators aim to identify if a specific sub-population within the T1DM population will benefit significantly from the intervention.', 'detailedDescription': 'Diabetes Mellitus (DM) is a chronic condition, and provision of individual and effective diabetes care is a major challenge. The is a lack of evidence on the optimal frequency of attending outpatient clinics for persons with T1DM.\n\nThe use of patient-reported outcome (PRO) measures in diabetes care area are limited and none existing in a Danish context. This includes studies, which combine PRO measure with diabetes management, patient involvement and self-management.\n\nThe study will generate knowledge and directions for ways to reframe and to optimize the future management of diabetes care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge over 18 years Have had T1DM for more than 1 years Be able to use the Danish-language general website on healthcare www.sundhed.dk Be mentally well functioning Understand and read Danish Access to internet'}, 'identificationModule': {'nctId': 'NCT03202732', 'briefTitle': 'DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes: A Randomised Controlled Trial and Interview Study', 'orgStudyIdInfo': {'id': 'DiabetesFlex2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DiabetesFlex', 'description': "In DiabetesFlex intervention, patients are offered 3 consultations/year. One mandatory consultations (30 minutes). The patient, an endocrinologist and a diabetes nurse attend.\n\nTwo optional consultations, patients can choose between face-to-face consultations, a telephone consultation or to cancel the consultation.\n\nAhead of the consultations, patients fill out the AmbuFlex Diabetes questionnaire and deliver a blood and urine sample.\n\nBased on the patient's response to the AmbuFlex Diabetes questionnaire, the result of the blood sample and the urine sample, the diabetes nurse assign the patient to a face-to-face consultation, a telephone consultation or no consultation with an endocrinologist, a diabetes nurse or a dietician.", 'interventionNames': ['Other: DiabetesFlex']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Standard diabetes care consists of 3 consultations (15 minutes)/year with a physician or a diabetes nurse by turns.\n\nAhead of the consultation patients send in a blood sample for measuring HgA1c, urine sample for measuring urin-albumin creatinin ratio and other blood samples depending of arrangements made in the last consultation.\n\nOnce a year in relation to a consultation, patients fill in the Problem Area In Diabetes (PAID) (20) scale together. Furthermore, based on the patients or healthcare professional judgement, patients see a dietician when needed.'}], 'interventions': [{'name': 'DiabetesFlex', 'type': 'OTHER', 'description': "DiabetesFlex consist of one mandatory and two optional consultations. Before the consultations patients receive the AmbuFlex Diabetes questionnaire.\n\nThe AmbuFlex Diabetes questionnaire is based on both validated questionnaires and clinical consensus. The AmbuFlex Diabetes questionnaire consists of: SF36 well-being question, WHO-5 Well-being Index. Questions concerning: HgA1c, home-based blood pressure monitoring, incidents of hypoglycemia, diabetes complications, regular eye check, regular food check, erectile dysfunction and peripheral neuropathy, The PAID scale, Topics patients may want to talk with the health care professional about, the patient's evaluation of the need for diabetes care. View the AmbuFlex Diabetes questionnaire at the homepage: www.diabetesflex.auh.dk.", 'armGroupLabels': ['DiabetesFlex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aahurs University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Annesofie L. Jensen, Postdoc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Annesofie Lunde Jensen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical nursespecialist postdoc', 'investigatorFullName': 'Annesofie Lunde Jensen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}