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Shared Decision Making in Graves Disease - Graves Disease (GD) Choice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02107794
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):
Victor Montori, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Graves' Disease Thyroid Disease Hyperthyroidism Other: Decision Aid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Shared Decision Making in Graves Disease - Graves Disease (GD) Choice
Study Start Date : December 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Decision Aid
Observation of clinical encounter using the decision aid, via video, audio or written notes.
Other: Decision Aid
Paper based decision aid will be utilized to facilitate treatment option conversation between clinician and patient.
Other Name: DA

No Intervention: Usual Care
Observations in clinical encounters, either video, audio, or observational notes.

Primary Outcome Measures :
  1. Decisional Quality (Knowledge, Decisional Conflict, Satisfaction) of 100 participants [ Time Frame: up to 2 weeks post-visit ]
    Outcome measure to be assessed through post-visit surveys.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults ≥ 18 years
  • Diagnosis of Graves Disease
  • Appointment with endocrinologist to discuss treatment options for Graves Disease

Exclusion Criteria:

  • Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02107794

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Victor M Montori, M.D. Mayo Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Victor Montori, M.D., Mayo Clinic Identifier: NCT02107794    
Other Study ID Numbers: 12-007708
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Victor Montori, Mayo Clinic:
Additional relevant MeSH terms:
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Graves Disease
Thyroid Diseases
Endocrine System Diseases
Orbital Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases