Abstract
ObjectiveMedication 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.MethodsThe 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.DiscussionThe study will assess the efficacy of a behavioral intervention to improve ULT adherence in minority populations with gout.Trial registrationClinicalTrials.gov NCT 02741700. Registered on 14 September 2018
Highlights
Medication non-adherence, i.e., not taking medications as prescribed, costs over $100 billion a year in excess hospitalizations in the USA [1]
The study will assess the efficacy of a behavioral intervention to improve urate-lowering therapy (ULT) adherence in minority populations with gout
Sample size and power Hypothesis 1: We hypothesize that the mean ULT adherence will be higher in the intervention versus the comparison groups Assuming a standard deviation (SD) of 15%, similar to the SD of 14% reported by Briesacher et al [2], 120 patients/group will provide 80% power to detect an absolute difference between means of 6% for MEMSCapTM ULT Medication possession ratio (MPR), assuming a control group adherence of 55%, intervention group mean of 61% [2], and using a two-tailed type I error rate of 0.05
Summary
Study objective The primary objective of this 1-year study is to assess the efficacy of a novel gout storytelling in patient’s own voice on ULT adherence in gout, assessed by an objective measure of ULT adherence assessed with MEMSCapTM electronic bottlecap monitoring at 6 months (primary trial end point) (Fig. 1). To minimize patient responder burden, veterans are only completing assessments related to primary and select secondary study outcomes (including a 4-item gout flare questionnaire) at each study follow-up visit. Sample size and power Hypothesis 1: We hypothesize that the mean ULT adherence will be higher in the intervention versus the comparison groups Assuming a standard deviation (SD) of 15%, similar to the SD of 14% reported by Briesacher et al [2], 120 patients/group (total of 306 to account for 18% drop out rate) will provide 80% power to detect an absolute difference between means of 6% for MEMSCapTM ULT MPR, assuming a control group adherence of 55%, intervention group mean of 61% (range, 0–100%) [2], and using a two-tailed type I error rate of 0.05.
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