SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout.
SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout.
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DOI：
10.1186/s12916-021-02135-w
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发表时间：
2021-11-09
期刊：
影响因子：
9.3
通讯作者：
Eisen S
中科院分区：
文献类型：
--
作者：
Singh JA;Joseph A;Baker J;Richman JS;Shaneyfelt T;Saag KG;Eisen S
痛风患者的降尿酸治疗 (ULT) 依从性较低，有效、低成本的干预措施即使有，也很少。我们的目标是评估在非洲裔美国人 (AA) 中，文化上适当的痛风故事讲述干预是否优于注意力控制来改善痛风结果。在一项为期一年的多中心随机对照试验中，患有痛风的 AA 退伍军人被随机分配到痛风讲故事干预组和减压视频组（注意力对照组；1:1 比例）。主要结果是使用 MEMSCap™ 测量 ULT 依从性，MEMSCap 是一种电子监测系统，可客观测量 ULT 药物依从性。 306 名符合资格标准的患有痛风的男性 AA 退伍军人被随机分配到痛风讲故事干预组 (n = 152) 或减压视频组 (n = 154)； 261/306 (85%) 完成了为期 1 年的研究。平均年龄64岁，体重指数33kg/m2，痛风病程3年。干预组与对照组的 ULT 依从性相似：3 个月，73% 对 70%； 6 个月，69% 对 69%； 9 个月，66% 对比 67%；和 12 个月，分别为 61% 和 64%（p > 0.05）。干预组与对照组的次要结局（痛风发作、血清尿酸和痛风特异性健康相关生活质量 [HRQOL]）在所有时间点均相似，但干预组在以下方面的结局更好：(1) 9 个月时痛风发作次数较少，为 0.7 次，而前一个月为 1.3 次 (p = 0.03)； (2) 两个痛风特定 HRQOL 分量表的得分更低/更高：3 个月时痛风药物副作用，32.8 比 39.6 (p = 0.02)； 3 个月时未满足的痛风治疗需求分别为 30.9 vs. 38.2 (p = 0.003) 和 6 个月时未满足的痛风治疗需求分别为 29.5 vs. 34.5 (p = 0.03)。在改善痛风 AA 患者的痛风结果方面，文化上适当的痛风讲故事干预并不优于注意力控制。在 ClinicalTrials.gov NCT02741700 上注册 在线版本包含可在 10.1186/s12916-021-02135-w 获取的补充材料。
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). 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. 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. A culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout. Registered at ClinicalTrials.gov NCT02741700 The online version contains supplementary material available at 10.1186/s12916-021-02135-w.
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