Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Any patient intolerant or unable to take ULTs (allopurinol or febuxostat)
Patients with a rheumatology encounter within the prior 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
Pharmacist-Led
Other interventionPharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment
Treatment groups
310 Participants
are divided into 2 treatment groupsGroup A: Pharmacist-LedExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
flare occurrence
The occurrence of two or more flares during year 2.
Time frame
during year two2
serum urate at goal
Achievement of serum urate \<6 mg/dL at end of year one.
Time frame
at end of year oneSecondary outcomes
1
Veterans RAND 12 (VR-12)
Quality of life instrument to assess components of physical and mental health. The survey asks about a patient's views on their health. The information will keep track of how a patient feels and how well they are able to do their usual activities. Scores include ranking their health from excellent to poor, whether physical or emotional health or pain limits activities or accomplishments, whether their health interferes with social activities and lastly asks patients to compare their physical and emotional health to one year ago. The scales range from not-at-all through all the time.
Time frame
Baseline visit, Months 6, 12, 18, and 242
Patient Reported Outcomes Measurement Information System (PROMIS)
Survey to assess pain on relevant aspects of a patient's life within the last 7 days. The survey asks whether or not pain interfered with enjoyment, concentration, outside-of-home tasks, and socialization. The scale is at a not at all (1) through very much (5).
Time frame
Baseline visit, Months 6, 12, 18, and 243
Gout-related patient global assessment
Participants will complete a rating scale on all the ways gout affects them on a 0-100 scale ranging from very well to very poor.
Time frame
Baseline visit, Months 6, 12, 18, and 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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