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

针对患有 2 型糖尿病的非裔美国成人以家庭为中心的糖尿病自我管理干预措施

• 批准号: 10585454
• 负责人: Jie Hu
• 金额: $ 31.5万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10585454
• 关键词: 2 arm randomized control trial; Address; Adherence; Adult; African American; African American population; Behavior; Behavioral; Behavioral Mechanisms; Blood Vessels; Calories; Carbohydrates; Clinic; Communication; Communities; Complications of Diabetes Mellitus; Data; Development; Diabetes Mellitus; Dietary intake; Disease Management; Education; Elderly; Enrollment; Extended Family; Family; Family member; Feedback; Foundations; Glycosylated hemoglobin A; Goals; Health; Health behavior and outcomes; Healthcare Systems; Healthy Eating; Hispanic; Hospitalization; Impaired cognition; Individual; Intake; Intervention; Knowledge; Life; Life Style; Low income; Measures; Mission; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Ohio; Outcome; Participant; Patient Recruitments; Patients; Pattern; Persons; Pharmacy facility; Phase; Physical activity; Population; Problem Solving; Process; Public Health; Quality of life; Randomized; Randomized, Controlled Trials; Research Priority; Risk Factors; Science; Self Management; Social Environment; Social Processes; Stress; Stress and Coping; Support Groups; Surveys; Telephone; Time; United States National Institutes of Health; Vulnerable Populations; Waiting Lists; Walking; Work; acceptability and feasibility; arm; behavior change; blood pressure control; clinical research site; comparison intervention; diabetes self-management; family support; follow-up; glycemic control; health disparity; health related quality of life; healthy lifestyle; improved; macrovascular disease; middle age; mortality; novel; novel strategies; participant enrollment; post intervention; primary outcome; recruit; retention rate; satisfaction; secondary outcome; skills; social; telephone session; treatment arm; treatment as usual

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.

项目总结/摘要 患有2型糖尿病（T2 D）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，糖尿病的发病率。患有T2 D的AA的住院时间是其他患者的3.2倍 与NHWs相比，未控制的糖尿病住院率。在个人方面， 人际、社区、社会和医疗保健系统水平有助于降低糖尿病自我治疗的依从性， 管理，实现血糖控制的难度更大，微血管和大血管的发生率更高 并发症美国国立卫生研究院行为改变科学将人际和社会过程确定为 行为改变的三个关键机制，为这一战略提供更大的支持。家庭是一个关键的社会 在这种背景下，相互依存，集体主义和大家庭网络是他们生活方式的核心， 原子吸收法事实上，对个体水平的关注仅证明了血糖控制的有限改善， 患有T2 D的AA。因此，有效的多层次干预，促进坚持糖尿病自我管理， 这些弱势群体是迫切需要的。我们提出的I/II期随机对照试验不仅将 改善T2 D参与者的血糖控制，同时让家庭成员参与体力活动， 健康饮食策略具体目标是：1.研究家庭二人组的可行性和可接受性， 在患有T2 D的AA成人及其指定家庭成员中进行集中的糖尿病干预; 2.审查 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 对照组：（1）血糖控制（血红蛋白A1 c）和健康相关生活质量（HRQOL）（主要 结果）;和（2）T2 D参与者的血压控制（次要结果）;和3.探讨 二元关系（质量和支持）及其与a）二元压力、体力活动 和饮食摄入量，以及B）随时间推移的健康结果（血糖控制、HRQOL和血压控制）， 参与者T2 D。我们将进行一项双组RCT。我们将入组104名患有T2 D的AA和1名家庭成员 每例患者（104对），以1：1的比例随机分配至干预或等待列表对照组（n=52/组）。所有参与者 将在药房诊所接受标准常规护理。干预中的患者-家庭成员配对 手臂将接受1）14个会议超过20周的家庭二元集中，在人的糖尿病自我小组会议， 管理和家庭支持; 2）在每个小组会议中以家庭为重点的支持部分;以及3） 个别家庭反馈电话会议。所有参与者将在基线、干预后 干预后六个月。我们的干预目标是鼓励参与者（1）每天自我- 管理糖尿病和压力;（2）建立健康的饮食模式，减少总热量和碳水化合物 摄入量;（3）每周进行150分钟或更长时间的快走;（4）使用以解决方案为中心的解决问题的方法 战略和支持性家庭沟通技巧。我们的方法将增加科学知识， 确定AA中坚持糖尿病自我管理的人际和社会机制。