NCT06887452

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
55mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2031

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

March 13, 2025

Last Update Submit

February 17, 2026

Conditions

GoutGouty Arthritis

Outcome Measures

Primary Outcomes (2)

  • flare occurrence

    The occurrence of two or more flares during year 2.

    during year two

  • serum urate at goal

    Achievement of serum urate \<6 mg/dL at end of year one.

    at end of year one

Secondary Outcomes (3)

  • Veterans RAND 12 (VR-12)

    Baseline visit, Months 6, 12, 18, and 24

  • Patient Reported Outcomes Measurement Information System (PROMIS)

    Baseline visit, Months 6, 12, 18, and 24

  • Gout-related patient global assessment

    Baseline visit, Months 6, 12, 18, and 24

Study Arms (2)

Pharmacist-Led

EXPERIMENTAL

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

Other: Pharmacist-Led

Usual care

NO INTERVENTION

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

Interventions

Pharmacist-LedOTHER

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

Pharmacist-Led

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any patient intolerant or unable to take ULTs (allopurinol or febuxostat)
  • Patients with a rheumatology encounter within the prior 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

Omaha, Nebraska, 68105-1850, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

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

Philadelphia, Pennsylvania, 19104-4551, United States

Location

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

Salt Lake City, Utah, 84148-0001, United States

Location

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

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

GoutArthritis, Gouty

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ted R. Mikuls

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bridget Kramer

CONTACT

(402) 995-3206bridget.kramer@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized multicenter, parallel-group study that will compare a pharmacist-led / telehealth delivered intervention to usual care in gout management
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 20, 2025

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

March 30, 2031

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(5)