Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-10 @ 11:38 PM
Study NCT ID:
NCT02714660
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2016-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Work of Being a Patient With Diabetes: Data Collection Via a Smartphone Application
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2016-03-17', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Score on Burden of Treatment Questionnaire', 'timeFrame': 'Baseline', 'description': 'The 48-item version of the Patient Experience with Treatment and Self-Care (PETS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This mixed methods study aims to answer the question: "What is the work of being a patient with type 2 diabetes mellitus?" .', 'detailedDescription': 'This study will describe how much time persons with type 2 diabetes mellitus spend on health management and the burden they experience from these activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with type 2 diabetes with receiving care at Mayo Clinic endocrinology department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* receiving medical care at Mayo Clinic endocrine subspecialty clinic\n* diagnosis of type 2 diabetes\n\nExclusion Criteria:\n\n* unable to provide consent\n* patients who reside in an extended care of intermediate care facility'}, 'identificationModule': {'nctId': 'NCT02714660', 'briefTitle': 'The Work of Being a Patient With Diabetes: Data Collection Via a Smartphone Application', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Work of Being a Patient: A Mixed Methods Characterization of the Work of Being a Patient With Type 2 Diabetes Mellitus Using Real-time Data Collection Via a Smartphone Application', 'orgStudyIdInfo': {'id': '15-005767'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Type 2 Diabetes', 'description': 'Adults with type 2 diabetes will be enrolled in this mixed methods observational study.', 'interventionNames': ['Other: none, observational study']}], 'interventions': [{'name': 'none, observational study', 'type': 'OTHER', 'armGroupLabels': ['Participants with Type 2 Diabetes']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Victor Montori, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Victor Montori', 'investigatorAffiliation': 'Mayo Clinic'}}}}