SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout

Abstract

Background: Urate-lowering therapy (ULT) adherence is low in gout, and few, if any, effective, low-cost, interventions are available. Our objective was to assess if a culturally appropriate gout-storytelling intervention is superior to an attention control for improving gout outcomes in African-Americans (AAs).

Methods: In a 1-year, multicenter, randomized controlled trial, AA veterans with gout were randomized to gout-storytelling intervention vs. a stress reduction video (attention control group; 1:1 ratio). The primary outcome was ULT adherence measured with MEMSCap™, an electronic monitoring system that objectively measured ULT medication adherence.

Results: The 306 male AA veterans with gout who met the eligibility criteria were randomized to the gout-storytelling intervention (n = 152) or stress reduction video (n = 154); 261/306 (85%) completed the 1-year study. The mean age was 64 years, body mass index was 33 kg/m2, and gout disease duration was 3 years. ULT adherence was similar in the intervention vs. control groups: 3 months, 73% versus 70%; 6 months, 69% versus 69%; 9 months, 66% versus 67%; and 12 months, 61% versus 64% (p > 0.05 each). Secondary outcomes (gout flares, serum urate and gout-specific health-related quality of life [HRQOL]) in the intervention versus control groups were similar at all time points except intervention group outcomes were better for the following: (1) number of gout flares at 9 months were fewer, 0.7 versus 1.3 in the previous month (p = 0.03); (2) lower/better scores on two gout specific HRQOL subscales: gout medication side effects at 3 months, 32.8 vs. 39.6 (p = 0.02); and unmet gout treatment need at 3 months, 30.9 vs. 38.2 (p = 0.003), and 6 months, 29.5 vs. 34.5 (p = 0.03), respectively.

Conclusions: A culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout.

Trial registration: Registered at ClinicalTrials.gov NCT02741700.

Keywords: Adherence; African American; Disparities; Gout; Medication adherence; Race/ethnicity; Randomized controlled trial; Storytelling; Trial; Urate-lowering therapy.

Conflict of interest statement

There are no financial conflicts related directly to this study JAS has received consultant fees from Crealta/Horizon, Medisys, Fidia, PK Med, Two labs Inc., Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, Jupiter Life Science, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology. JAS owns stock options in TPT Global Tech, Vaxart pharmaceuticals and Charlotte’s Web Holdings, Inc. JAS previously owned stock options in Amarin, Viking, and Moderna pharmaceuticals. JAS is on the speaker’s bureau of Simply Speaking. JAS is a member of the executive of Outcomes Measures in Rheumatology (OMERACT), an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. JAS serves on the FDA Arthritis Advisory Committee. JAS is the chair of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the University of Alabama at Birmingham (UAB) Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. JAS previously served as a member of the following committees: member, the American College of Rheumatology’s (ACR) Annual Meeting Planning Committee (AMPC) and Quality of Care Committees, the Chair of the ACR Meet-the-Professor, Workshop and Study Group Subcommittee and the co-chair of the ACR Criteria and Response Criteria subcommittee.

Drs. Baker, Richman, and Shaneyfelt have no financial conflicts.

Dr. Eisen has received research support from Bristol Myers Squibb.

Dr. Joseph has received research support from Bristol Myers Squibb.

Dr. Saag has received research support from Horizon, Sobi, and Shanton and consulting fees from Arthrosi, Atom Bioscience, Horizon, Inflazome, L. G. Pharma, Mallinckrodt, Takeda, and Sobi pharmaceuticals.

© 2021. The Author(s).

Figures

Fig. 1

Study participant CONSORT diagram

Fig. 2

Treatment vs. control group differences in primary outcome of ULT MPR by pre-specified subgroups. Point estimates are presented as squares and the whiskers represent the 95% confidence intervals

Fig. 3

Treatment vs. control group differences in gout-specific HRQOL and gout flares in the last month at each study time point. Point estimates are presented as squares and the whiskers represent the 95% confidence intervals