The Depression/Hyptertension COACH Study - supplement

描述（由申请人提供）：中国老年人抑郁/高血压-健康协作（COACH）研究是一项随机对照试验（RCT），比较了COACH干预与CAU治疗中国农村老年人抑郁和HTN共病的效果。COACH将老年人初级保健提供者提供的护理与老龄工作者提供的护理相结合，老龄工作者是村里老龄协会的一名非专业成员，由一名精神病顾问监督。根据慢性病管理原则，初级保健医生接受培训，使用循证实践指南治疗高血压和抑郁症，并获得有关患者抑郁症最佳管理的心理健康咨询。助理医生接受培训，对老年人的社会背景进行系统评估，以确定和减少影响治疗依从性和反应的社会和环境障碍。AW与PCP一起为他们共同的患者制定多学科护理计划，加强治疗依从性和健康行为的采用，并强调老年人的激活和参与旨在改善他们与他人和社区联系的活动。最后，PCP、AW和精神科医生顾问接受培训，以便在共同的客户护理中进行合作。将对160个村庄进行随机分配，向居住在那里的合格受试者提供COACH或CAU（每个村庄约有15名受试者符合标准），或总计约2400名受试者。治疗将持续一年，并在基线、3个月、6个月、9个月和12个月进行研究评估。将从EMR和管理记录中获取使用数据。研究的具体目的是确定COACH在治疗抑郁症（目标1）和HTN（目标2）方面是否比CAU更有效;治疗依从性的改善是否先于抑郁症的减少和血压控制的改善（目标3a），以及抑郁症症状的改善是否先于血压控制的改善（目标3b）; COACH是否比CAU更能改善健康相关的生活质量（目标4）; 2并比较两种方法的相关成本（目标5）。

DESCRIPTION (provided by applicant): The Depression/Hypertension in Chinese Older Adults - Collaborations in Health (COACH) Study is a randomized controlled trial (RCT) comparing the COACH intervention to CAU for the treatment of comorbid depression and HTN in Chinese older adult rural village residents. COACH integrates the care provided by the older person's primary care provider (PCP) with that delivered by an Aging Worker (AW; a lay member of the village's Aging Association), supervised by a psychiatrist consultant. Based on chronic disease management principles, the PCP is trained to use evidence based practice guidelines for treatment of both HTN and depression, and provided with access to mental health consultation regarding optimal management of the patient's depression. The AW is trained to conduct a systematic assessment of the older person's social context to identify and reduce social and environmental barriers to treatment adherence and response. AWs participate with the PCP in developing multi-disciplinary care plans for their shared patients, reinforce treatment adherence and adoption of healthy behaviors, and emphasize activation and engagement of the older person in activities designed to improve their connectedness to others and to the community. Finally, PCP, AW, and Psychiatrist Consultant are trained to collaborate in their shared clients' care. 160 villages will be randomized to deliver COACH or CAU to eligible subjects who reside there (approximately 15 per village will meet criteria), or a total of about 2400 subjects. Treatment will continue for one year, with research evaluations at baseline, 3 6, 9, and 12 months. Utilization data will be obtained from the EMR and administrative records. Specific aims of the study are to determine whether COACH is more effective than CAU in treating depression (Aim 1) and HTN (Aim 2); whether improvements in treatment adherence precede reductions in depression and improvement in BP control (Aim 3a), and whether improvements in depression symptoms precede improvements in BP control (Aim 3b); if COACH is associated with greater improvements in health- related quality of life than CAU (Aim 4); and to compare the costs associated with each approach (Aim 5).