Gout, Gouty Arthritis
Conditions
Brief summary
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
OTHERPharmacist-Led
Pharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized multicenter, parallel-group study that will compare a pharmacist-led / telehealth delivered intervention to usual care in gout management
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| flare occurrence | during year two | The occurrence of two or more flares during year 2. |
| serum urate at goal | at end of year one | Achievement of serum urate \<6 mg/dL at end of year one. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Veterans RAND 12 (VR-12) | Baseline visit, Months 6, 12, 18, and 24 | 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. |
| Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline visit, Months 6, 12, 18, and 24 | 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). |
| Gout-related patient global assessment | Baseline visit, Months 6, 12, 18, and 24 | 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. |
Countries
United States
Contacts
CONTACTBridget Kramer
PRINCIPAL_INVESTIGATORTed R. Mikuls
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Outcome results
None listed