SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) in African American veterans with gout: a trial study protocol.
SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) in African American veterans with gout: a trial study protocol.
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SToRytelling改善痛风（ESTDE-GO）在非裔美国退伍军人痛风疾病的结果：一项试验研究方案。
DOI：
10.1186/s13063-021-05847-9
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发表时间：
2021-12-04
期刊：
影响因子：
2.5
通讯作者：
Singh JA
中科院分区：
文献类型：
--
作者：
Singh JA
痛风患者的用药依从性不佳，缺乏有效的干预措施来解决这一问题是一个巨大的挑战。在少数族裔中，服药依从性和痛风结果更差。这篇文章的目的是为痛风患者的随机对照试验(RCT)提供研究方案的细节，以测试适合文化的痛风讲故事干预的有效性。这项名为STORytelliing to Improving Disease Outsings in Gout(STRIDE-GO)的研究将是一项为期12个月的多中心开放标签随机对照试验，将评估至少300名患有痛风的AA退伍军人使用符合文化习惯的痛风故事的效果。参与者将被随机分为痛风故事干预组和压力缓解视频组，比例为1：1。主要结果是用电子监测系统MEMSCap™测量尿酸降低治疗(ULT)的依从性(有效时间为6个月，有效时间为12个月)。次要结果包括痛风发作、血清尿酸(SU)、痛风特有的健康相关生活质量[HRQOL]、自我报告的服药依从性、患者对治疗的满意度以及患者对干预措施的理解。患有痛风的AA退伍军人如果符合1977年美国风湿病学会(ACR)对痛风的初步分类标准，目前至少开了6个月的口服药物(别嘌醇或非布索坦)，并且没有使用药盒重新分配他们的药物，将被邀请进行面对面的研究访问。在研究协调员获得知情同意并确保参与者符合纳入标准后，符合条件的参与者将获得为期1个月的MEMSCap™瓶中的当前ULT，并被要求在1个月后返回诊所。ULT遵守MEMSCap™将在1个月的回访中记录下来。感兴趣的参与者将完成基线评估，使用计算机化系统随机选择痛风讲故事干预或减压干预视频臂，并观看各自的门诊视频。患者将在2个月和4个月时就每次在家观看视频的情况进行电话采访。参与者将在3个月、6个月、9个月和12个月时在诊所接受评估；MEMSCap™数据和患者调查将在每次访问时捕获。对于任何错过的就诊，将在电话中完成评估，并在下一次门诊就诊时捕获MEMSCap™数据。这项研究将评估行为干预的有效性，以改善患有痛风的少数民族人群的成人依从性。临床试验网站nct 02741700。在线版本于2018年9月14日登记，载有补充材料，可在10.1186/s13063-021-05847-9查阅。
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. 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. The study will assess the efficacy of a behavioral intervention to improve ULT adherence in minority populations with gout. ClinicalTrials.gov NCT 02741700. Registered on 14 September 2018 The online version contains supplementary material available at 10.1186/s13063-021-05847-9.
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