Massachusetts General Hospital
Hyon Choi
The TRUST study is a randomized, controlled multicenter study to evaluate the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine the most beneficial for a patient-centered gout outcomes, as well as relevant cardiovascular-metabolic-renal endpoints.
Gout
Allopurinol
Naproxen 250 MG
Colchicine 0.6 mg
Colchicine 1.2 mg
Naproxen 500 Mg
Prednisone 40 mg
PHASE4
This trial aims to answer a fundamental question in the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine which is most beneficial for a range of patient-centered gout outcomes, as well as relevant CV-metabolic-renal endpoints. Designing a scientifically valid and pragmatic clinical trial involves numerous tradeoffs in study design, subject eligibility criteria, and outcome measurement. We have come together as primary care physicians and rheumatologists to consider several alternative designs. We first considered the target study population. Since most rheumatologists believe that the TTT approach is superior, it would be difficult to recruit from rheumatology practices. Thus, we aimed to design a trial that would be feasible to conduct in primary care practices, with an intervention that could primarily be run by nurses and physician assistants. This design would be pragmatic and generalizable to primary care practices outside of the setting of a randomized controlled trial. The trial also needs to incorporate the perspectives of rheumatologists, primary care clinicians, allied specialists, and patients when deciding the key issues to be addressed and how best to answer these questions.76 We convened a modified Delphi Panel (mDP) to solicit input using a formal process of voting and discussion. The Delphi Panel is a commonly used approach in health care for areas where there is less than perfect data to make decisions. It also has been used in the social sciences as a method for formalizing input from multiple parties, using voting and discussion.77,78 We selected a broadly representative group of mDP panelists from four categories of constituents who could inform the trial design: patients, nurses, primary care physicians, and rheumatologists. Two voting rounds were held, including a video conference meeting to discuss all the voting questions and re-vote on items where no consensus had been reached on the first round.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 650 participants |
Masking : | DOUBLE |
Primary Purpose : | TREATMENT |
Official Title : | Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: a Randomized Controlled Trial |
Actual Study Start Date : | 2024-02-22 |
Estimated Primary Completion Date : | 2028-09-01 |
Estimated Study Completion Date : | 2028-10-31 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 90 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
NOT YET RECRUITING
The University of Alabama at Birmingham
South Birmingham, Alabama, United States, 35233
NOT YET RECRUITING
UCLA Health
Santa Monica, California, United States, 90404
RECRUITING
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
RECRUITING
Brigham and Women's Hospital (BWH)
Boston, Massachusetts, United States, 02115
NOT YET RECRUITING
Boston Medical Center (BMC)
Boston, Massachusetts, United States, 02119
RECRUITING
NYU Langone
NY, New York, United States, 10010
NOT YET RECRUITING
West Virginia University (Including Mobile Clinical Trials Unit)
Morgantown, West Virginia, United States, 26506