Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pharmacist-Led.
- Who it may be relevant to
- Registry conditions: Gout, Gouty Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients in Gout (Pharm-UP) Study
Overview
This study will compare two different approaches to manage medications that lower uric acid levels. This study will be conducted at five VA medical centers across the United States and will take 4-5 years to complete. Individual participation will last up to two years.
Detailed description
This project will quantify and compare the effects of a pharmacist-led telehealth-delivered intervention versus usual care on arthritis flare burden and serum urate goal achievement in 310 U.S. Veterans with gout enrolled from five VA medical centers. The project will quantify the effects of the intervention on patient-reported outcomes (improvements in health-related quality of life, pain interference, and participant global assessment).
Interventions
- Other Pharmacist-Led
Pharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment
Primary outcome measures
- flare occurrence [Time frame: during year two]
- serum urate at goal [Time frame: at end of year one]
Secondary outcome measures (3)
- Veterans RAND 12 (VR-12) [Time frame: Baseline visit, Months 6, 12, 18, and 24]
- Patient Reported Outcomes Measurement Information System (PROMIS) [Time frame: Baseline visit, Months 6, 12, 18, and 24]
- Gout-related patient global assessment [Time frame: Baseline visit, Months 6, 12, 18, and 24]
Eligibility criteria
Inclusion criteria
- US Veterans over the age of 18 years with physician-diagnosed
- Documented hyperuricemia (SU >6.8 mg/dL)
- Satisfy ACR/EULAR gout classification criteria
- Report 1 or more flares in the prior 6 months
- Receipt of a new ULT prescription (allopurinol or febuxostat) initiated by a primary care provider or longer term ULT but otherwise satisfy the flare/SU criteria
Exclusion criteria
- Any patient intolerant or unable to take ULTs (allopurinol or febuxostat)
- Patients with a rheumatology encounter within the prior 3 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha
- VA Portland Health Care System, Portland, OR — Portland
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle
Identifiers
NCT: NCT06887452 · IMMA-005-24F · CX002995