Pyatak Elizabeth A, Carandang Kristine, Vigen Cheryl, Blanchard Jeanine, Sequeira Paola A, Wood Jamie R, Spruijt-Metz Donna, Whittemore Robin, Peters Anne L
Division of Occupational Science and Occupational Therapy, University of Southern California, 1540 Alcazar St., CHP-133, Los Angeles, USA.
Division of Occupational Science and Occupational Therapy, University of Southern California, 1540 Alcazar St., CHP-133, Los Angeles, USA.
Contemp Clin Trials. 2017 Mar;54:8-17. doi: 10.1016/j.cct.2016.12.025. Epub 2017 Jan 5.
This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist.
In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity.
At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence.
Participants in the REAL study demonstrate clinically significant medical and psychosocial needs.
本文描述了用于评估“糖尿病患者的韧性、赋权与积极生活（REAL Diabetes）”干预措施的研究方案，并报告了招募参与者的基线特征。REAL Diabetes是一项基于活动的干预措施，旨在满足来自社会经济地位较低或少数种族/族裔背景、被诊断为1型糖尿病（T1D）或2型糖尿病（T2D）的年轻人的需求。REAL干预措施包括由持牌职业治疗师量身定制地提供七个内容模块，这些模块涉及与糖尿病相关的健康和幸福的各个方面。
在这项试点随机对照试验中，参与者被分配到REAL Diabetes干预组或注意力控制组。该研究的主要招募策略包括在糖尿病诊所进行面对面招募、向诊所患者大量邮寄宣传材料以及社交媒体广告。数据收集包括对主要结局、次要结局以及干预效果的假设中介因素进行基线和6个月评估，以及进行持续的过程评估，以确保研究方案的依从性和干预的保真度。
在基线时，参与者（n = 81）中51%为女性，78%为拉丁裔，平均年龄22.6岁，平均糖化血红蛋白（HbA1c）为10.8%。大多数参与者（61.7%）表现出具有临床意义的糖尿病困扰，27.2%报告有与重度抑郁症相符的症状。与T1D患者相比，T2D患者的糖尿病相关自我效能和解决问题的能力较低。与在诊所招募的参与者相比，通过其他策略招募的参与者糖尿病知识更丰富，但药物依从性较差。
REAL研究中的参与者表现出具有临床意义的医疗和心理社会需求。
