SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) in African American veterans with gout: a trial study protocol

Abstract

Objective: Medication adherence in gout is suboptimal, and the lack of effective interventions to address it presents a huge challenge. Medication adherence and gout outcomes are worse in racial/ethnic minorities. The objective of this paper was to provide the details of the study protocol for randomized, controlled trial (RCT) in African Americans (AAs) with gout that will test the effectiveness of a culturally appropriate gout storytelling intervention.

Methods: The SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) study will be a 12-month, multicenter, open-label RCT that will assess the effect of a culturally appropriate gout storytelling in at least 300 AA veterans with gout. Participants will be randomized to gout-storytelling intervention vs. a stress reduction video in a 1:1 ratio. The primary outcome is urate-lowering therapy (ULT) adherence measured with MEMSCap™, an electronic monitoring system (efficacy, 6 months; sustenance of efficacy, 12 months). Secondary outcomes include gout flares, serum urate (SU), gout-specific health-related quality of life [HRQOL], self-reported ULT adherence, patient satisfaction with treatment, and patient understanding of the intervention. AA veterans with gout who met the 1977 Preliminary American College of Rheumatology (ACR) classification criteria for gout, currently prescribed an oral ULT medication (allopurinol or febuxostat) for at least 6 months, and not using a pillbox to redistribute their medications, will be invited to an in-person study visit. After the study coordinators obtain informed consent, and ensure that participants meet the inclusion criteria, the eligible participants will be provided with their current ULT in a MEMSCap™ bottle for the 1-month run-in period and asked to return to the clinic in 1 month. ULT adherence with MEMSCap™ will be recorded at a 1-month return visit. Interested participants will complete the baseline assessments, randomized using the computerized system to either gout-storytelling intervention or a stress reduction intervention video arm and watch the respective video in-clinic. Patients will be interviewed on the phone at 2 and 4 months regarding the viewing of the videos at home at each time. Participants will be assessed in-clinic at 3, 6, 9, and 12 months; MEMSCap™ data and patient surveys will be captured at each visit. For any missed visit, assessments will be completed on the phone and MEMSCap™ data captured at the next in-clinic visit.

Discussion: The study will assess the efficacy of a behavioral intervention to improve ULT adherence in minority populations with gout.

Trial registration: ClinicalTrials.gov NCT02741700. Registered on 14 September 2018.

Keywords: African American; Behavioral intervention; Gout; Racial/ethnic minorities; Randomized trial; Storytelling intervention.

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, 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, Atyu biopharma, Adaptimmune Therapeutics, GeoVax Labs, Pieris Pharmaceuticals, Enzolytics Inc., Seres Therapeutics Tonix Pharmaceuticals Holding Corp., 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 has received institutional research support from Zimmer Biomet Holdings. JAS received food and beverage payments from Intuitive Surgical Inc./Philips Electronics North America. 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 a member of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the 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.

© 2021. The Author(s).

Figures

Fig. 1

Study flow diagram. R, randomization. Study visits to be completed at home are shown without shading. Study visits to be completed in the clinic are shown with gray shading. Phone pre-screening and 2- and 4-month at-home telephone surveys will be done by the study coordinator on the phone at the pre-scheduled time with the patient. DVD1 and DVD2 will be provided to the patient per the patient preference at the preceding visit, or mailed to the patient and the receipt confirmed, prior to the call. All in-clinic surveys are patient self-administered outcome assessments completed directly on an IPAD by the patient during the in-clinic visits. In case a patient misses a scheduled study visit, they will be rescheduled for a study visit in the next 1–2 weeks. If that fails, or is not possible, a phone interview is done by the coordinator with the patient to complete all patient surveys, and the MEMSCap is read at the next in-clinic visit