Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults
Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults
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DOI：
10.1016/j.cct.2016.12.025
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发表时间：
2017-03-01
影响因子：
2.2
通讯作者：
Peters, Anne L.
中科院分区：
文献类型：
--
作者：
Pyatak, Elizabeth A.;Carandang, Kristine;Peters, Anne L.
概述：本文描述了用于评估弹性，授权，积极的糖尿病生活（真实的的糖尿病）干预的研究方案，并报告了招募的参与者的基线特征。真实的Diabetes是一种基于活动的干预措施，旨在满足来自低社会经济地位或种族/少数民族背景的1型（T1 D）或2型糖尿病（T2 D）年轻人的需求。真实的干预纳入量身定制的交付七个内容模块，解决健康和福祉的各个方面，因为它们涉及到糖尿病，由持牌职业therapeutic therapeutic.Methods：在这个试点随机对照试验，参与者被分配到真实的的糖尿病干预或注意力控制条件。该研究的主要招募策略包括糖尿病诊所的面对面招募，向诊所患者发送大量邮件和社交媒体广告。数据收集包括基线和6个月的主要成果，次要成果，和假设的中介干预效果的评估，以及正在进行的过程评价评估，以确保研究方案的遵守和干预fidelity.Results：在基线时，参与者（n = 81）是51%的女性，78%的拉丁美洲人，平均22.6岁，平均HbAlc为10.8%。大多数参与者（61.7%）表现出临床显著的糖尿病困扰，272%的人报告了与重度抑郁症一致的症状。与T1 D参与者相比，T2 D参与者具有较低的糖尿病相关自我效能和解决问题的技能。在诊所招募的参与者相比，通过其他策略招募的参与者有更大的糖尿病知识，但较弱的药物administration.Discussion：参与者在真实的研究表现出临床显着的医疗和心理社会需求。(C)2017 Elsevier Inc版权所有。
Overview: 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.Methods: 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.Results: At baseline, participants (n = 81) were 51% female, 78% Latino, and on average 22.6 years old with an average HbAl c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 272% 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.Discussion: Participants in the REAL study demonstrate clinically significant medical and psychosocial needs. (C) 2017 Elsevier Inc All rights reserved.