A Family-Dyad-focused Diabetes Self-Management Intervention for African American Adults with Type 2 Diabetes

项目摘要/摘要 患有2型糖尿病(T2D)的非裔美国人(AA)的血糖控制较差，死亡率高出50% 与非西班牙裔白人(NHW)相比，糖尿病的比率。使用T2D的AAS的住院时间是T2D的3.2倍 未控制糖尿病的入院人数与卫生保健人员的比较。个人的多重因素交织在一起， 人际、社区、社会和医疗保健系统水平有助于降低对糖尿病自身的依从性 管理，实现血糖控制的难度更大，微血管和大血管的比率更高 并发症。美国国立卫生研究院的行为变化科学认为，人际和社会过程是 行为改变的三个关键机制，为这一战略提供了更大的支持。家庭是一个至关重要的社会 相互依赖、集体主义和大家庭网络是他们生活方式的核心 美国医学会。事实上，专注于个体水平的血糖控制仅显示出有限的改善。 原子吸收光谱与T2D。因此，有效的多层次干预措施可促进坚持糖尿病自我管理。 这些弱势群体是迫切需要的。我们提议的I/II期随机对照试验不仅将 改善T2D参与者的血糖控制，但也让家庭成员参与体力活动和 健康饮食策略。具体目标是：1.审查家庭-二元体-的可行性和可接受性- 对患有T2D的AA成人及其指定的家庭成员进行重点糖尿病干预；2.检查 以家庭为中心的糖尿病自我管理干预与等待名单的初步疗效比较 控制臂：(1)血糖控制(血红蛋白A1c)和与健康相关的生活质量(HRQOL)(主要 结果)；和(2)患有T2D的参与者的血压控制(次要结果)；以及3.探讨 二元关系(质量和支持)及其与a)二元应激、体力活动变化的关系 和饮食摄入量，以及b)随着时间的推移的健康结果(血糖控制、HRQOL和血压控制) 使用T2D的参与者。我们将进行一次双臂RCT。我们将招收104名具有T2D和一名家庭成员的AA 对每个患者(104对)，随机1：1进入干预或等待名单对照组(n=52/组)。所有参与者 将接受在药房诊所进行的标准常规护理。干预中的患者-家庭成员二元组 ARM将接受为期20周的为期20周的以家庭为中心的、面对面的糖尿病自我小组会议 管理和家庭支持；2)每个小组会议中以家庭为重点的支持部分；3) 个别家庭反馈电话会议。所有参与者将在干预后的基线进行评估 干预后六个月。我们的干预目标是鼓励参与者(1)日常自我 控制糖尿病和压力；(2)建立健康的饮食模式，减少总卡路里和碳水化合物 摄入量；(3)每周快走150分钟或更长时间；(4)使用专注于解决问题的方法 策略和支持性的家庭沟通技巧。我们的方法将增加科学知识和 确定在AA中坚持糖尿病自我管理的人际和社会机制。

Project Summary/Abstract African Americans (AAs) with Type 2 diabetes (T2D) have worse glycemic control and a 50% higher mortality rate of diabetes compared to non-Hispanic Whites (NHWs). AAs with T2D have 3.2 times more hospital admissions for uncontrolled diabetes compared to NHWs. Multiple, intertwined factors at the individual, interpersonal, community, societal, and healthcare system levels contribute to lower adherence to diabetes self- management, greater difficulty achieving glycemic control, and higher rates of microvascular and macrovascular complications. The NIH Science of Behavior Change identifies interpersonal and social processes as one of the three key mechanisms for behavior change, providing greater support for this strategy. Family is a critical social context in which interdependence, collectivism, and extended family network is central to their way of life among AAs. Indeed, focusing on the individual-level demonstrated only limited improvements in glycemic control for AAs with T2D. Thus, effective multi-level interventions that promote adherence to diabetes self-management in this vulnerable population are sorely needed. Our proposed phase I/II randomized controlled trial will not only improve glycemic control for participants with T2D, but also engage family members in physical activity and healthy eating strategies. The specific aims are: 1. to examine the feasibility and acceptability of a family-dyad- focused diabetes intervention in AA adults with T2D and their designated family members; 2. to examine the preliminary efficacy of the family-dyad-focused diabetes self-management intervention compared to a waitlist control arm on: (1) glycemic control (hemoglobin A1c) and health-related quality of life (HRQOL) (primary outcomes); and (2) blood pressure control (secondary outcome) in participants with T2D; and 3. to explore the dyadic relationship (quality and support) and its association with a) changes in dyadic stress, physical activity and dietary intake, and b) health outcomes (glycemic control, HRQOL and blood pressure control) over time in participants with T2D. We will conduct a two-arm RCT. We will enroll 104 AAs with T2D and one family member of each patient (104 dyads), randomized 1:1 to intervention or wait list control arm (n=52/arm). All participants will undergo the standard usual care held at the pharmacy clinic. Patient-family-member dyads in the intervention arm will receive 1) 14 session over 20 weeks of family dyad-focused, in-person group sessions on diabetes self- management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions. All participants will be assessed at baseline, post-intervention and six months after intervention. Our goals of the intervention are to encourage participants to (1) daily self- manage diabetes and stress; (2) establish a healthy eating pattern reducing overall calorie and carbohydrate intake; (3) engage in brisk walking of 150 or more minutes a week; and (4) use solution-focused problem-solving strategy and supportive family communication skills. Our approach will add to the scientific knowledge and identify interpersonal and social mechanisms in adherence to diabetes self-management among AAs.