一项混合方法随机对照试验的设计与原理：解决健康素养、信念、依从性和自我效能（ADHERE）计划以改善糖尿病结局
Design and rationale of a mixed methods randomized control trial: ADdressing Health literacy, bEliefs, adheRence and self-Efficacy (ADHERE) program to improve diabetes outcomes.
作者信息
Shiyanbola Olayinka O, Walbrandt Pigarelli Denise L, Unni Elizabeth J, Smith Paul D, Maurer Martha A, Huang Yen-Ming
机构信息
Division of Social and Administrative Sciences, School of Pharmacy, University of Wisconsin-Madison, WI, USA.
Division of Pharmacy Practice, School of Pharmacy, University of Wisconsin-Madison, WI, USA.
出版信息
Contemp Clin Trials Commun. 2019 Jan 14;14:100326. doi: 10.1016/j.conctc.2019.100326. eCollection 2019 Jun.
BACKGROUND
Improving medication adherence is one of the most effective approaches to improving the health outcomes of patients with diabetes. To date, enhancing diabetes medication adherence has occurred by improving diabetes-related knowledge. Unfortunately, behavior change often does not follow knowledge change. Enhancing communication between patients and healthcare professionals through addressing health literacy-related psychosocial attributes is critical.
OBJECTIVE
Examine whether a patient-centered intervention augmenting usual care with a health literacy-psychosocial support intervention will improve medication adherence for patients with diabetes, compared to usual care.
METHODS
This study is a randomized controlled trial with an intervention mixed methods design. Fifty participants being enrolled are English-speaking, 18-80 years old with diagnosed diabetes, take at least one diabetes medication, have low diabetes medication adherence (proportion of days covered less than 80% or based on clinical notes), and have poor diabetes control (hemoglobin A1c of ≥8%). Participants will be allocated to either a control group receiving usual care (n = 25) or an intervention group (n = 25) receiving usual care and a 6-session intervention focusing on the modifiable psychosocial factors that may influence medication adherence. A questionnaire will be administered at baseline and at the end of the intervention to all participants to assess the effectiveness of the intervention. Fifteen participants from the intervention group will be interviewed to explore participants' experiences and perceptions of the intervention processes and outcomes.
CONCLUSIONS
The trial will examine if a patient-centered intervention that addresses patients' health literacy and focuses on modifiable psychosocial factors will improve medication adherence among patients with diabetes.
背景
提高药物治疗依从性是改善糖尿病患者健康结局的最有效方法之一。迄今为止，通过提高糖尿病相关知识来增强糖尿病药物治疗依从性。不幸的是，行为改变往往不会随着知识改变而发生。通过解决与健康素养相关的心理社会因素来加强患者与医护人员之间的沟通至关重要。
目的
与常规护理相比，研究以患者为中心的干预措施（通过健康素养心理社会支持干预增强常规护理）是否会改善糖尿病患者的药物治疗依从性。
方法
本研究是一项采用干预混合方法设计的随机对照试验。招募的50名参与者为18至80岁、会说英语、被诊断患有糖尿病、至少服用一种糖尿病药物、糖尿病药物治疗依从性低（覆盖天数比例小于80%或根据临床记录）且糖尿病控制不佳（糖化血红蛋白≥8%）。参与者将被分配到接受常规护理的对照组（n = 25）或接受常规护理和为期6次干预的干预组（n = 25），该干预侧重于可能影响药物治疗依从性的可改变心理社会因素。在基线和干预结束时对所有参与者进行问卷调查，以评估干预效果。将对干预组的15名参与者进行访谈，以探讨参与者对干预过程和结果的体验和看法。
结论
该试验将研究以患者为中心、解决患者健康素养问题并侧重于可改变心理社会因素的干预措施是否会改善糖尿病患者的药物治疗依从性。
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