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在长期试验中留住患有糖尿病的多样化成年人:策略、成功和经验教训。

Retaining diverse adults with diabetes in a long-term trial: Strategies, successes, and lessons learned.

机构信息

Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Diabetes Translation Research, Vanderbilt University Medical Center, Nashville, TN, USA.

Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA; DeBusk College of Osteopathic Medicine, Lincoln Memorial University, Knoxville, TN, USA.

出版信息

Contemp Clin Trials. 2021 Jun;105:106388. doi: 10.1016/j.cct.2021.106388. Epub 2021 Apr 2.

Abstract

Background Retention can be difficult in longitudinal trials, especially among minoritized groups and individuals with low socioeconomic status (SES) who may experience more barriers to research participation. Organized retention strategies may help; however, limited research has reported on this in detail. Methods We employed several strategies throughout a 15-month randomized controlled trial to encourage retention among a diverse sample of adults with type 2 diabetes. Participants were randomized to receive mobile health support for diabetes self-care for 12 months or an attention control. Participants completed assessments at 3, 6, 12, and 15 months post-baseline. We used three main categories of retention strategies: flexibility in participation (e.g., multiple methods for data collection), communication (e.g., tracking contacts), and community building (e.g., study branding, newsletters). We monitored participants' use of strategies and examined associations between participant characteristics and retention. Results Retention remained high (≥90%) at each follow-up assessment. Participants used various methods for survey completion: online (34%), in-person (31%), and mail (30%). Most (73%) used a mail-in A1c kit at least once. Multiple completion methods were important for retaining minoritized and lower SES participants who completed assessments in-person more frequently. Communication also facilitated retention; 39% of participants used a study Helpline and tracking systems helped maintain contact. Conclusions Retaining disadvantaged patients in clinical trials is necessary so findings generalize to and can benefit these populations. Retention strategies that reduce barriers to participation and engage participants and community partners can be successful. Future studies should assess the impact of retention strategies.

摘要

背景

纵向研究中保留率可能较低,尤其是在少数群体和社会经济地位较低的个体中,他们可能在参与研究方面面临更多障碍。有组织的保留策略可能会有所帮助;然而,有限的研究对此进行了详细的报道。

方法

在一项为期 15 个月的随机对照试验中,我们采用了多种策略来鼓励不同类型 2 型糖尿病成年患者的保留率。参与者被随机分配接受为期 12 个月的移动健康支持糖尿病自我护理或注意力对照组。参与者在基线后 3、6、12 和 15 个月完成评估。我们使用了三种主要的保留策略类别:参与的灵活性(例如,数据收集的多种方法)、沟通(例如,跟踪联系人)和社区建设(例如,研究品牌、时事通讯)。我们监测了参与者对策略的使用情况,并检查了参与者特征与保留率之间的关联。

结果

每次随访评估的保留率均保持在 90%以上。参与者使用各种方法完成调查:在线(34%)、亲自(31%)和邮寄(30%)。大多数人(73%)至少使用过一次邮寄 A1c 试剂盒。多种完成方法对于保留少数民族和社会经济地位较低的参与者非常重要,他们更频繁地亲自完成评估。沟通也促进了保留率;39%的参与者使用了研究热线,跟踪系统有助于保持联系。

结论

在临床试验中保留弱势群体患者非常必要,以便研究结果能够推广并使这些人群受益。减少参与障碍并使参与者和社区合作伙伴参与的保留策略可以取得成功。未来的研究应该评估保留策略的影响。

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