Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial.
Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial.
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糖尿病自我管理教育和支持（DSMES）计划一直在努力为成年糖尿病患者（AWD）提供可持续的有效支持，以改善自我管理行为，实现血糖目标，并降低并发症的风险。AWD的社交网络是这种支持的一个基本上未开发的资源。50%到75%的AWD有一个无偿的家庭成员或朋友（“支持者”），他们提供持续的糖尿病管理帮助。然而，DSMES干预措施迄今缺乏结构化和有效的方法来直接参与AWD糖尿病管理的支持人员。这项平行组随机试验旨在确定家庭支持健康行动（FAM-ACT）的有效性，这是一项新的社区卫生工作者（CHW）提供的计划，重点是教育和支持2型糖尿病（T2 D）患者及其支持人员（SP），相对于已建立的，CHW提供的，以个体患者为中心的DSMES和护理管理（I-DSMES）干预。这两种干预措施都是使用基于社区的参与性研究（CBPR）方法制定的。本研究将与一家服务于低收入、拉丁裔/a社区的城市联邦合格健康中心（CIMHC）合作开展，目标入组268对患者，包括1例HbA 1c高的CIMHC T2 D患者和1例SP。患者-SP对患者将随机接受FAM-ACT或I-DSMES治疗6个月。主要结局是患者HbA 1c从基线至6个月的变化。次要患者结局包括12个月HbA 1c变化、患者血压变化、糖尿病自我管理行为、糖尿病痛苦、患者激活、糖尿病自我效能以及对糖尿病SP支持的感知和满意度。次要SP结果包括帮助患者进行糖尿病管理的自我效能和SP对患者糖尿病的困扰。我们亦将评估COVID-19大流行对患者管理糖尿病能力的影响。这项研究将为可扩展的循证方法提供信息，这些方法利用家庭支持来帮助AWD改善和维持自我管理策略，这些策略是多种糖尿病并发症风险因素的最佳管理的基础。该协议是专为低收入和主要是拉丁裔/社区，这可能会增加适用于其他类似的社区进行评估。COVID-19大流行对研究方案和干预措施的实施提出了若干挑战;描述了为应对这些挑战而做出的修改。ClinicalTrials.gov NCT03812614。于2019年1月18日注册。在线版本包含补充材料，可通过10.1186/s13063-022-06764-1获得。
Diabetes self-management education and support (DSMES) programs have struggled to deliver sustainable, effective support for adults with diabetes (AWDs) to improve self-management behaviors, achieve glycemic goals, and reduce risk for complications. One largely untapped resource for this support is AWDs’ social networks. Fifty to 75% of AWDs have an unpaid family member or friend (“support person”) who provides ongoing help with diabetes management. However, DSMES interventions to date lack structured and effective approaches to directly engage support persons in AWDs’ diabetes management. This parallel arm randomized trial is designed to determine the effectiveness of Family Support for Health Action (FAM-ACT), a novel community health worker (CHW)-delivered program focused on educating and supporting patients with type 2 diabetes (T2D) and their support persons (SPs), relative to an established, CHW-delivered, individual patient-focused DSMES and care management (I-DSMES) intervention. Both interventions were developed using a community-based participatory research (CBPR) approach. The study will be conducted in partnership with an urban Federally Qualified Health Center (FQHC) serving a low-income, Latino/a community, with target enrollment of 268 dyads consisting of an FQHC patient with T2D with high HbA1c and an SP. Patient-SP dyads will be randomized to receive FAM-ACT or I-DSMES over 6 months. The primary outcome is change in patient HbA1c from baseline to 6 months. Secondary patient outcomes include 12-month change in HbA1c, changes in patient blood pressure, diabetes self-management behaviors, diabetes distress, patient activation, diabetes self-efficacy, and perceptions of and satisfaction with SP support for diabetes. Secondary SP outcomes include self-efficacy for helping the patient with diabetes management and SP distress about the patient’s diabetes. We also will assess the effect of the COVID-19 pandemic on patient’s ability to manage diabetes. This study will inform scalable, evidence-based approaches that leverage family support to help AWDs improve and sustain self-management strategies that underpin optimal management of multiple diabetes complication risk factors. The protocol is designed for and evaluated with a low-income and predominantly Latino/a community, which may increase applicability to other similar communities. The COVID-19 pandemic presented several challenges to study protocol and intervention delivery; modifications made to address these challenges are described. ClinicalTrials.gov NCT03812614. Registered on 18 January 2019. The online version contains supplementary material available at 10.1186/s13063-022-06764-1.
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影响因子：
1.9
作者：
Sentell TL;Shen C;Landsittel D;Mays MH;Southerland J;King MH;Taira DA
通讯作者：
Taira DA
影响因子：
5.2
作者：
Baig AA;Benitez A;Quinn MT;Burnet DL
通讯作者：
Burnet DL
影响因子：
3.7
作者：
Hirst JA;Stevens RJ;Farmer AJ
通讯作者：
Farmer AJ
影响因子：
3.8
作者：
Baek, Rachel N.;Tanenbaum, Molly L.;Gonzalez, Jeffrey S.
通讯作者：
Gonzalez, Jeffrey S.
影响因子：
4.2
作者：
Haw JS;Shah M;Turbow S;Egeolu M;Umpierrez G
通讯作者：
Umpierrez G