Medicine Service, VA Medical Center, 510, 20th street South, FOT 805B, Birmingham, AL, 35233, USA.
Department of Medicine at School of Medicine, University of Alabama at Birmingham, 1720 Second Ave. South, Birmingham, AL, 35294-0022, USA.
Trials. 2021 Dec 4;22(1):879. doi: 10.1186/s13063-021-05847-9.
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 NCT02741700. Registered on 14 September 2018.
痛风患者的用药依从性并不理想，缺乏有效的干预措施是一个巨大的挑战。在少数族裔中，用药依从性和痛风结局更差。本文的目的是提供一项针对非裔美国人（AA）痛风患者的随机对照试验（RCT）的研究方案细节，该试验将测试一种文化上适当的痛风故事讲述干预措施的有效性。
STORytelli 改善痛风结局（STRIDE-GO）研究将是一项为期 12 个月、多中心、开放性 RCT，将评估在至少 300 名患有痛风的 AA 退伍军人中使用一种文化上适当的痛风故事讲述对尿酸降低治疗（ULT）依从性的影响。参与者将按照 1:1 的比例随机分配到痛风故事讲述干预组或减压视频组。主要结局是使用电子监测系统（MEMSCap）测量的 ULT 依从性（功效，6 个月；功效维持，12 个月）。次要结局包括痛风发作、血清尿酸（SU）、痛风特异性健康相关生活质量（HRQOL）、自我报告的 ULT 依从性、患者对治疗的满意度以及患者对干预措施的理解。符合 1977 年美国风湿病学会（ACR）痛风初步分类标准、目前至少服用 6 个月口服 ULT 药物（别嘌醇或非布司他）且不使用药盒重新分配药物的痛风退伍军人，将被邀请参加现场研究访问。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，合格的参与者将在 MEMSCap 瓶中获得他们当前的 ULT，进行为期 1 个月的预试验期，并在 1 个月后返回诊所。将在 1 个月的复诊时记录 ULT 对 MEMSCap 的依从性。有兴趣的参与者将完成基线评估，使用计算机系统随机分配到痛风故事讲述干预组或减压视频干预组，并在诊所观看相应的视频。在每次视频观看后，患者将在 2 个月和 4 个月通过电话接受关于在家观看视频的访谈。参与者将在 3、6、9 和 12 个月时在诊所进行评估；每次就诊时都会采集 MEMSCap 数据和患者调查。对于任何错过的就诊，将通过电话进行评估，并在下一次就诊时采集 MEMSCap 数据。
该研究将评估一种行为干预措施在痛风少数民族人群中提高 ULT 依从性的效果。
ClinicalTrials.gov NCT02741700。于 2018 年 9 月 14 日注册。
