Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-25 @ 2:59 AM
Study NCT ID:
NCT02107794
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2014-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shared Decision Making in Graves Disease - Graves Disease (GD) Choice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D006379', 'term': 'Helping Behavior'}], 'ancestors': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003661', 'term': 'Decision Support Techniques'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decisional Quality (Knowledge, Decisional Conflict, Satisfaction) of 100 participants', 'timeFrame': 'up to 2 weeks post-visit', 'description': 'Outcome measure to be assessed through post-visit surveys.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Grave's", 'Disease', 'Thyroid', 'Hyperthyroidism', 'Thyroidectomy', 'Radioactive', 'Iodine', 'Antithyroid', 'Shared', 'Decision', 'Making', 'Aid', 'Evidence', 'Based', 'Endocrinology', 'Mayo', 'Clinic'], 'conditions': ["Graves' Disease", 'Thyroid Disease', 'Hyperthyroidism']}, 'referencesModule': {'references': [{'pmid': '26413979', 'type': 'DERIVED', 'citation': "Brito JP, Castaneda-Guarderas A, Gionfriddo MR, Ospina NS, Maraka S, Dean DS, Castro MR, Fatourechi V, Gharib H, Stan MN, Branda ME, Bahn RS, Montori VM. Development and Pilot Testing of an Encounter Tool for Shared Decision Making About the Treatment of Graves' Disease. Thyroid. 2015 Nov;25(11):1191-8. doi: 10.1089/thy.2015.0277. Epub 2015 Oct 15."}]}, 'descriptionModule': {'briefSummary': "The investigators' decision aid for patients with GD, GD Choice, will be the result of a user-centered participatory action research involving) synthesis of the best available evidence from the literature and real-world registry experience, ii) input and involvement of patients, clinicians and other stakeholders, iii) direct observation of encounters and iv) extensive field-testing. The goal is to create a decision aid that will be rigorously evidence-based, clear and complete, able to be used by clinicians with minimal training time, while satisfying extant standards for rigorous high-quality shared decision making tools."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥ 18 years\n* Diagnosis of Graves Disease\n* Appointment with endocrinologist to discuss treatment options for Graves Disease\n\nExclusion Criteria:\n\n* Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)'}, 'identificationModule': {'nctId': 'NCT02107794', 'briefTitle': 'Shared Decision Making in Graves Disease - Graves Disease (GD) Choice', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Shared Decision Making in Graves Disease - Graves Disease (GD) Choice', 'orgStudyIdInfo': {'id': '12-007708'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Decision Aid', 'description': 'Observation of clinical encounter using the decision aid, via video, audio or written notes.', 'interventionNames': ['Other: Decision Aid']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Observations in clinical encounters, either video, audio, or observational notes.'}], 'interventions': [{'name': 'Decision Aid', 'type': 'OTHER', 'otherNames': ['DA'], 'description': 'Paper based decision aid will be utilized to facilitate treatment option conversation between clinician and patient.', 'armGroupLabels': ['Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Victor M Montori, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Victor Montori', 'investigatorAffiliation': 'Mayo Clinic'}}}}