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

NCT ID: NCT06887452

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2030-09-30

Brief Summary

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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

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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).

Conditions

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Gout Gouty Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized multicenter, parallel-group study that will compare a pharmacist-led / telehealth delivered intervention to usual care in gout management
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pharmacist-Led

Intervention Type OTHER

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

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pharmacist-Led

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ted R. Mikuls

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Omaha, Nebraska, United States

Site Status

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

Site Status

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

Philadelphia, Pennsylvania, United States

Site Status

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

Salt Lake City, Utah, United States

Site Status

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

Seattle, Washington, United States

Site Status

Countries

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United States

Central Contacts

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Bridget Kramer

Role: CONTACT

(402) 995-3206

Facility Contacts

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Bridget Kramer

Role: primary

402-995-3206

Alexandra Bennett

Role: primary

503-220-8262 ext. 52472

Criswell Lavery, MPH

Role: primary

215-823-5800

Jennifer Godina

Role: primary

Hannah Brubeck

Role: primary

206-764-2673

Other Identifiers

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CX002995

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IMMA-005-24F

Identifier Type: -

Identifier Source: org_study_id

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