Using Multifamily Groups to Improve Family-Centered Self-Management of Type 2 Diabetes among Mexican Americans

 描述（由申请人提供）：此R-01赠款提案是对PA-14-112“以家庭为中心的慢性病自我管理”的回应。“该项目（a）在公共卫生环境中使用顺序、多重分配随机试验评估四种文化适应的、以家庭为基础的治疗方法，旨在改善患有2型糖尿病的墨西哥裔美国人的健康状况、自我管理行为和自我效能，以及（B）测试关于Ryan和Sawin的个人和家庭自我管理理论的适用性的假设，干预的关键结构的概念基础，在这一人群中的糖尿病自我管理的研究。之所以选择这一概念模式进行研究，是因为它强调家庭成员作为护理伙伴的整合，同时促进疾病的自我管理，这与研究人群和拟议的干预措施密切相关。西班牙语，墨西哥裔美国2型糖尿病患者及其家属将从一家大型城市公立医院附属的初级保健诊所招募，该医院位于洛杉矶的墨西哥裔美国人占主导地位的地区。在研究的第一阶段，受试者将被随机分配到6个2.5小时的疗程（3个月）：1）Tomando Control de su Diabetes（TC），这是一种文化定制的、基于社区的糖尿病自我管理计划，由社区卫生工作者（promotoras）与个体患者和家庭合作，以小组形式提供;或2）由卫生专业人员（执业护士）提供的TC。将在基线、3个月、6个月和12个月时进行评价。治疗6周后（在干预的中间点），将评估受试者的糖尿病自我管理行为的改善（主要结局）。在研究的第二阶段，糖尿病自我管理行为较基线改善50%的受试者将继续接受指定的治疗，持续3个月。那些不符合这一目标的受试者将被重新随机分配接受：1）TC的增强版本，特别关注家庭成员的参与;或2）由经过糖尿病自我管理技能教学专门培训的护士领导的多家庭小组治疗，为期三个月。将评估受试者设定和遵守与糖尿病相关的自我管理目标;自我管理行为，包括遵守ADA饮食、参与运动活动、监测血糖水平和服用处方降糖药物;糖尿病自我效能;以及血红蛋白A1 c水平。家庭成员将在这些相同的时间范围内进行评估，以确定他们的糖尿病护理知识;与患病亲属和医疗保健提供者的合作目标设定水平;以及家庭支持水平。研究结果将促进对影响墨西哥裔美国人2型糖尿病自我管理的因素的理解，并将为构建适应性干预提供有价值的信息，这将有助于确定哪些治疗策略最有效地改善糖尿病自我管理行为。

 DESCRIPTION (provided by applicant): This R-01 grant proposal is a response to PA-14-112 "A Family-Centered Self-Management of Chronic Conditions." The project (a) evaluates four culturally adapted, family-based treatments designed to improve health status, self-management behaviors and self-efficacy among Mexican-Americans with Type 2 diabetes using a Sequential, Multiple Assignment Randomized Trial in a public health setting, and (b) tests hypotheses about the applicability of Ryan and Sawin's Individual and Family Self-Management Theory, the conceptual foundation for the intervention's key constructs, to the study of diabetes self-management in this population. This conceptual model was selected for study because its emphasis on the integration of family members as partners in care while promoting illness self-management is highly germane to the study population and to the proposed intervention. Spanish speaking, Mexican-American patients with Type 2 diabetes and their families will be recruited from a primary care clinic affiliated with a large, urban public hospital located in a predominantly Mexican American area of Los Angeles. In the first phase of the study, subjects will be randomly assigned to six 2.5 hour sessions (three months) of either: 1) Tomando Control de su Diabetes (TC), a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by community health workers (promotoras) working with individual patients and families; or 2) TC delivered by health professionals (licensed nurses). Evaluations will be made at baseline, three months, six months and 12 months. After six weeks of treatment (at the midway point of the intervention), subjects will be assessed for improvement in diabetes self-management behaviors (the primary outcome). In the second phase of the study, those subjects who have improved their diabetes self-management behaviors by 50% over baseline will be continued in their assigned treatment for the duration of three months. Those subjects who do not meet this target will be re-randomized to receive either: 1) an augmented version of TC that has a specific focus on engaging family members; or 2) a multifamily group treatment led by nurses specially trained in teaching diabetes self-management skills for an additional three months. Subjects will be assessed on setting and adhering to self-management goals related to diabetes; self-management behaviors including adhering to the ADA diet, engaging in exercise activities, monitoring glucose levels and taking prescribed hypoglycemic medications; diabetes self-efficacy; and hemoglobin A1c levels. Family members will be assessed during these same time frames to determine their knowledge of diabetes care; levels of collaborative goal setting with their ill relative and the health care provider; and levels of family support. The results will advance the understanding of the factors that affect self-management for Mexican-Americans with Type 2 diabetes, and will provide valuable information towards constructing an adaptive intervention that will help to determine which treatment strategies work to improve diabetes self-management behaviors most efficiently and for whom.