Sharp Lisa Kay, Biggers Alana, Perez Rosanne, Henkins Julia, Tilton Jessica, Gerber Ben S
Department of Pharmacy Systems, Outcomes & Policy, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, United States.
Department of Medicine, Section of Academic Internal Medicine & Geriatrics, University of Illinois at Chicago, Chicago, IL, United States.
JMIR Res Protoc. 2021 Mar 10;10(3):e17170. doi: 10.2196/17170.
Aggressive management of blood glucose, blood pressure, and cholesterol through medication and lifestyle adherence is necessary to minimize the adverse health outcomes of type 2 diabetes. However, numerous psychosocial and environmental barriers to adherence prevent low-income, urban, and ethnic minority populations from achieving their management goals, resulting in diabetes complications. Health coaches working with clinical pharmacists represent a promising strategy for addressing common diabetes management barriers. Mobile health (mHealth) tools may further enhance their ability to support vulnerable minority populations in diabetes management.
The aim of this study is to evaluate the impact of an mHealth clinical pharmacist and health coach-delivered intervention on hemoglobin A (HbA, primary outcome), blood pressure, and low-density lipoprotein (secondary outcomes) in African-Americans and Latinos with poorly controlled type 2 diabetes.
A 2-year, randomized controlled crossover study will evaluate the effectiveness of an mHealth diabetes intervention delivered by a health coach and clinical pharmacist team compared with usual care. All patients will receive 1 year of team intervention, including lifestyle and medication support delivered in the home with videoconferencing and text messages. All patients will also receive 1 year of usual care without team intervention and no home visits. The order of the conditions received will be randomized. Our recruitment goal is 220 urban African-American or Latino adults with uncontrolled type 2 diabetes (HbA ≥8%) receiving care from a largely minority-serving, urban academic medical center. The intervention includes the following: health coaches supporting patients through home visits, phone calls, and text messaging and clinical pharmacists supporting patients through videoconferences facilitated by health coaches. Data collection includes physiologic (HbA, blood pressure, weight, and lipid profile) and survey measures (medication adherence, diabetes-related behaviors, and quality of life). Data collection during the second year of study will determine the maintenance of any physiological improvement among participants receiving the intervention during the first year.
Participant enrollment began in March 2017. We have recruited 221 patients. Intervention delivery and data collection will continue until November 2021. The results are expected to be published by May 2022.
This is among the first trials to incorporate health coaches, clinical pharmacists, and mHealth technologies to increase access to diabetes support among urban African-Americans and Latinos to achieve therapeutic goals.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17170.
通过药物治疗和坚持健康生活方式积极管理血糖、血压和胆固醇，对于将2型糖尿病的不良健康后果降至最低至关重要。然而，众多影响依从性的社会心理和环境障碍使低收入、城市和少数族裔人群无法实现管理目标，从而导致糖尿病并发症。健康教练与临床药剂师合作是解决常见糖尿病管理障碍的一项有前景的策略。移动健康（mHealth）工具可能会进一步增强他们支持弱势少数群体进行糖尿病管理的能力。
本研究旨在评估由移动健康临床药剂师和健康教练提供的干预措施对2型糖尿病控制不佳的非裔美国人和拉丁裔患者的糖化血红蛋白（HbA，主要结局）、血压和低密度脂蛋白（次要结局）的影响。
一项为期2年的随机对照交叉研究将评估由健康教练和临床药剂师团队提供的移动健康糖尿病干预措施与常规护理相比的有效性。所有患者将接受1年的团队干预，包括通过视频会议和短信在家中提供的生活方式和药物支持。所有患者还将接受1年的无团队干预且无家访的常规护理。接受干预的顺序将是随机的。我们的招募目标是220名来自主要为少数族裔服务的城市学术医疗中心的2型糖尿病控制不佳（HbA≥8%）的城市非裔美国或拉丁裔成年人。干预措施包括：健康教练通过家访、电话和短信为患者提供支持，临床药剂师通过由健康教练协助的视频会议为患者提供支持。数据收集包括生理指标（HbA、血压、体重和血脂谱）和调查指标（药物依从性、糖尿病相关行为和生活质量）。研究第二年的数据收集将确定在第一年接受干预的参与者中任何生理改善的维持情况。
参与者招募于2017年3月开始。我们已招募了221名患者。干预措施的实施和数据收集将持续到2021年11月。预计结果将于2022年5月公布。
这是首批纳入健康教练、临床药剂师和移动健康技术以增加城市非裔美国人和拉丁裔获得糖尿病支持以实现治疗目标的试验之一。
国际注册报告识别码（IRRID）：DERR1-10.2196/17170。
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