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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 8, 2014
Last Update Posted: April 7, 2015
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.
Information provided by (Responsible Party):
Victor Montori, Mayo Clinic
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 Intervention
Graves' Disease Thyroid Disease Hyperthyroidism Other: Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Shared Decision Making in Graves Disease - Graves Disease (GD) Choice

Resource links provided by NLM:

Further study details as provided by Victor Montori, Mayo Clinic:

Primary Outcome Measures:
  • 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.

Enrollment: 93
Study Start Date: December 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02107794

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Victor M Montori, M.D. Mayo Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Victor Montori, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02107794     History of Changes
Other Study ID Numbers: 12-007708
First Submitted: March 24, 2014
First Posted: April 8, 2014
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Victor Montori, Mayo Clinic:

Additional relevant MeSH terms:
Graves Disease
Thyroid Diseases
Orbital Diseases
Eye Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases