Graves' DiseaseNCT02107794
Shared Decision Making in Graves Disease - Graves Disease (GD) Choice
A study testing Decision Aid in people with Graves' Disease and Thyroid Disease, run by Mayo Clinic at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves' Disease, Thyroid Disease, Hyperthyroidism
- What is being tested?
- Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years
- Diagnosis of Graves Disease
- Appointment with endocrinologist to discuss treatment options for Graves Disease
Who cannot join
- Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Graves' Disease, Thyroid Disease, Hyperthyroidism
- Being tested
- Decision Aid
- Keywords
- Grave's, Disease, Thyroid, Hyperthyroidism, Thyroidectomy, Radioactive, Iodine, Antithyroid, Shared, Decision, Making, Aid, Evidence, Based, Endocrinology, Mayo, Clinic
- Medical subject headings
- Graves Disease, Thyroid Diseases, Hyperthyroidism, Disease, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
Also called DA
Paper based decision aid will be utilized to facilitate treatment option conversation between clinician and patient.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid | Active comparator | Observation of clinical encounter using the decision aid, via video, audio or written notes. Receives: Other: Decision Aid |
| Usual Care | No intervention | Observations in clinical encounters, either video, audio, or observational notes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Quality (Knowledge, Decisional Conflict, Satisfaction) of 100 participants
Outcome measure to be assessed through post-visit surveys.
Measured: up to 2 weeks post-visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startDec 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graves' DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Montori, Mayo Clinic
- Investigators
- Victor M Montori, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107794
- Sponsor's protocol ID
- 12-007708
- Status last verified
- Apr 2015
- First submitted
- 24 Mar 2014
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26413979
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in Graves Disease - Graves Disease (GD) Choice
- ClinicalTrials.gov ID
- NCT02107794
- Acronym / sponsor ID
- 12-007708
- Conditions
- Graves' Disease, Thyroid Disease, Hyperthyroidism
- Keywords
- Grave's, Disease, Thyroid, Hyperthyroidism, Thyroidectomy, Radioactive, Iodine, Antithyroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid | Active comparator | Other: Decision AidObservation of clinical encounter using the decision aid, via video, audio or written notes. |
| Usual Care | No intervention | –Observations in clinical encounters, either video, audio, or observational notes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥ 18 years
- Diagnosis of Graves Disease
- Appointment with endocrinologist to discuss treatment options for Graves Disease
Key exclusion criteria (1 listed)
- Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidAlso: DAPaper based decision aid will be utilized to facilitate treatment option conversation between clinician and patient. | Other | Decision Aid |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Derived from this study: PubMed 26413979Brito 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor M Montori, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Graves' Disease and Thyroid Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Quality (Knowledge, Decisional Conflict, Satisfaction) of 100 participants (time frame: up to 2 weeks post-visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02107794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.