Abstract
BackgroundUrate-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).MethodsIn 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.ResultsThe 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.ConclusionsA culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout.Trial registrationRegistered at ClinicalTrials.gov NCT02741700
Highlights
Urate-lowering therapy (ULT) adherence is low in gout, and few, if any, effective, low-cost, interventions are available
Two protocol modifications were made prior to study initiation: (1) based on the variable relationship between pharmacy record-based ULT Medication Possession Ratio (MPR) at baseline (3 vs. 6 vs. 12 months) and patient self-reported adherence during screening, we decided to add a 1-month run-in period prior to randomization using MEMSCapTM data and use MEMSCapTM ULT MPR as the measure of baseline adherence rather than pharmacy records; (2) we found that many patients had allopurinol MEMSCapTM ULT MPR of ≥ 80% during the 1-month run-in, suggesting the possibility of a Hawthorne effect on ULT adherence that would result in potentially excluding at-risk patients if < 80% adherence threshold was used an entry criterion
Gout flares in the treatment vs. control groups were similar 1.4 versus 1.4 in the last month, and 2.3 versus 2.5 in the last two months, respectively (Table 1)
Summary
Urate-lowering therapy (ULT) adherence is low in gout, and few, if any, effective, low-cost, interventions are available. Gout leads to disproportionately higher disease burden in African Americans (AAs) compared to Caucasians: (1) gout prevalence and incidence are 1.3- and 1.7-fold higher [1, 2]; (2) allopurinol treatment rates were lower (odds ratio 0.18) [3]; (3) non-adherence to uratelowering therapy (ULT; a key recommendation from all gout treatment guidelines) [4] was 2-fold higher [5]; and (4) baseline serum urate was higher (SU; 7.9 vs 7.1), achievement of target SU < 6 mg/dl (odds ratio, 0.67) is lower [6]; and (5) rates of emergency room visits and hospitalizations for gout were 2.6 times higher [6]. We developed a novel, culturally appropriate gout-storytelling intervention targeting ULT adherence for AAs, based on qualitative work with the target population [13]
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