Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06887452
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

VA Office of Research and Development
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ted R. Mikuls
Principal Investigator Affiliation Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

U.S. Fed
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gout, Gouty Arthritis
Additional Details

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).

Arms & Interventions

Arms

Experimental: Pharmacist-Led

Veterans will participate in regular telehealth visits with study pharmacists. Serum urate lab tests will be ordered during dose escalation phase of gout treatment.

No Intervention: Usual care

Veterans will receive standard care from their primary care provider for the management of their gout.

Interventions

Other: - Pharmacist-Led

Pharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Omaha, Nebraska

Status

Address

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, 68105-1850

Site Contact

Bridget Kramer

[email protected]

402-995-3206

Portland, Oregon

Status

Address

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964

Site Contact

Alexandra Bennett

[email protected]

503-220-8262 #52472

Philadelphia, Pennsylvania

Status

Address

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104-4551

Site Contact

Criswell Lavery, MPH

[email protected]

215-823-5800

Salt Lake City, Utah

Status

Address

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001

Site Contact

Jennifer Godina

[email protected]

(402) 995-3206

Seattle, Washington

Status

Address

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532

Site Contact

Hannah Brubeck

[email protected]

206-764-2673