Mobile Phone Support for Adults and Support Persons to Live Well with Diabetes

项目摘要 对于患有2型糖尿病（T2 D）的成年人，日常自我护理行为的表现可以改善血糖控制并预防糖尿病。 并发症和过早死亡。然而，持续的自我护理仍然具有很大的挑战性， 痛苦是常见的。家庭成员和朋友可以加强或削弱病人的自我照顾，许多人 因为不知道如何最好地支持患者的自我护理努力而感到苦恼。虽然家人/朋友 支持人员可能是改善T2 D结果的一种非常有效的方式，但很少对此进行研究。解决 针对这些问题，我们开发了FAMS，这是一种移动的电话干预，包括电话辅导， 改善社会支持和自我护理目标，并为患者提供短信支持，为他们的成年人提供短信支持 支持的人。我们的初步研究表明，FAMS是可接受的，可行的，改善了患者获得的支持， 而且它可能会改善自我照顾。为了推动这一有前途的研究方向，我们现在提出以下建议 具体目标：目标1：扩大和改进家庭资产管理系统。我们会在先导研究的基础上，进一步发展：（a）扩大财务管理系统的内容 除了饮食和身体活动之外，还包括方案定制的药物依从性策略，（B）扩展其互动性， 短信功能，以支持人们，以及（c）通过纳入循证的 糖尿病教育材料。这将通过以用户为中心的迭代测试来实现，以识别和解决内容， 技术、研究过程和可用性问题。目的2：评价FAMS 2.0对T2 D患者结局的影响。我们将 对334名患者-支持者配对（约50%同居）进行RCT，以评估扩展的 FAMS 2.0干预与注意力控制（关于T2 D自我护理的打印材料和A1 c结果的访问）对长期 长期血糖控制（主要结局）和社会心理健康（次要结局）。成人T2 D和 基线A1 c>7.5%将通过中南临床数据研究网络确定和招募，并将招募 和一个支持者我们将对种族/少数民族背景或社会经济地位低的患者进行过采样 status.将在A1 c和痛苦定义的二项分层内进行随机化。15个月研究时间轴 将包括9个月的干预期和6个月的随访，以评估持续效果。我们亦会评估 关键的过程测量，包括辅导忠诚度和短信回复率。目标3：探索FAMS 2.0对 支助人员。我们将评估分配到FAMS 2.0的支持人员在以下方面是否有更大的改进： 他们自己的支持负担和心理健康比那些分配到控制。目标4：检验假设 目标2和3所述效应的调节剂和介导剂。我们将评估是否对患者和 他们的支持者因性别和二元同居而异，如果有针对性的心理社会和 行为机制介导患者和SP结果的改善。完成这项拟议的研究将 确定这种高度新颖的干预措施是否改善了T2 D成人及其支持者的结局， 谁，通过什么机制。它还将产生固有的可扩展干预和强大的基础设施， 支持后续实施研究。

PROJECT SUMMARY For adults with type 2 diabetes (T2D), daily performance of self-care behaviors improves glycemic control and prevents complications and premature mortality. However, sustained self-care remains highly challenging and high diabetes distress is common. Family members and friends can either reinforce or undermine patients’ self-care, and many experience distress about not knowing how to best support the patient’s self-care efforts. Although engaging family/friend support persons may be a highly effective way to improve T2D outcomes, this has rarely been investigated. To address these problems, we developed FAMS, a mobile phone-delivered intervention including telephonic coaching focused on improving social support and self-care goals plus text message support for patients, and text messages for their adult support person. Our pilot study demonstrates that FAMS is acceptable, feasible, improves the support patients receive, and that it likely improves self-care. To move this promising line of research forward, we now propose the following specific aims: Aim 1: Expand and improve FAMS. We will build on our pilot study by: (a) expanding FAMS content beyond diet and physical activity to include regimen-tailored medication adherence strategies, (b) extending its interactive text message functionality to support persons, and (c) enhancing its goal-setting element by incorporating evidence-based diabetes education materials. This will be achieved through iterative user-centered testing to identify and resolve content, technical, research process and usability issues. Aim 2: Evaluate FAMS 2.0 effects on T2D patients’ outcomes. We will conduct an RCT with 334 patient-support person dyads (~50% cohabitating) to evaluate the effects of the expanded FAMS 2.0 intervention versus an attention control (print materials on T2D self-care and access to A1c results) on long- term glycemic control (primary outcome) and psychosocial well-being (secondary outcome). Adults with T2D and baseline A1c>7.5% will be identified and recruited via the Mid-South Clinical Data Research Network and will enroll with a support person. We will oversample patients of racial/ethnic minority background or who have low socioeconomic status. Randomization will be performed within binomial strata defined by A1c and distress. The 15-month study timeline will consist of a 9-month intervention period with a 6-month follow-up to evaluate sustained effects. We will also assess key process measures including coaching fidelity and text message response rates. Aim 3: Explore FAMS 2.0 effects on support persons. We will evaluate whether support persons assigned to FAMS 2.0 experience greater improvements in their own support burden and psychosocial well-being than those assigned to control. Aim 4: Examine hypothesized moderators and mediators of the effects specified in Aims 2 and 3. We will evaluate whether effects on patients and their support persons vary by gender and dyadic cohabitation, and if improvements in targeted psychosocial and behavioral mechanisms mediate improvements in patients’ and SPs’ outcomes. Completion of this proposed research will establish whether this highly novel intervention improves outcomes among adults with T2D and their support persons, for whom, and through what mechanisms. It will also yield an inherently scalable intervention and a robust infrastructure to support subsequent implementation research.