Virtual Gout Clinic

NCT02790463 | Completed Results

• 1 other identifier: X121119002
• Study Type: interventional
• Target: 1,463
• Locations: 1 country
• Sites: 2

Brief Summary

The overarching goal of the investigators project is to identify best practices in gout and hyperuricemia management, translate these evidence-based practices into a highly generalizable strategy for optimal delivery of gout care, and implement and evaluate such a strategy in a large, population-based healthcare setting. With the use of novel but readily-accessible technology, the investigators will examine the use of a novel, large-scale, and relatively low-cost pharmacy-based intervention, with the goal of optimizing urate lower therapy (ULT) in chronic gout treatment.

Conditions

Gout

Keywords

Allopurinol

Outcome Measures

Primary Outcomes (2)

• sUA < 6.0 mg/dl at 1 Year

  Achievement of serum uric acid (sUA) \< 6.0 mg/dl at 1 year

  12 months

• Adherence to Medication

  Adherence to prescribed medication

  12 months

Study Arms (2)

Usual Care

NO INTERVENTION

Participants recruited in this arm will receive their usual care for gout as they normally would

Intervention

ACTIVE COMPARATOR

Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention

Behavioral: Pharmacist-Led Intervention

Interventions

Pharmacist-Led Intervention BEHAVIORAL

Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one prior International Classification of Disease (ICD) 9 code for gout (274.xx)
• Received a new prescription for allopurinol, defined as no prior allopurinol prescription in the preceding 12 months

You may not qualify if:

• No prior ICD9 code for gout (274.xx)
• Did not receive a new prescription for allopurinol, defined as no prior allopurinol prescription in the preceding 12 months

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Nebraska: collaborator
• Kaiser Permanente: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Kaiser Permanente

Pasadena, California, 91101, United States

Location

Related Publications (1)

• Mikuls TR, Cheetham TC, Levy GD, Rashid N, Kerimian A, Low KJ, Coburn BW, Redden DT, Saag KG, Foster PJ, Chen L, Curtis JR. Adherence and Outcomes with Urate-Lowering Therapy: A Site-Randomized Trial. Am J Med. 2019 Mar;132(3):354-361. doi: 10.1016/j.amjmed.2018.11.011. Epub 2018 Nov 29.

  PMID: 30503879 DERIVED

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Jeff Foster
• Organization: UNIVERSITY OF ALABAMA AT BIRMINGHAM

pjfoster@uabmc.edu

205-996-6086

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 3, 2016
• Study Start: January 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)