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

项目总结 对于患有2型糖尿病(T2D)的成年人来说，日常自我护理行为可以改善血糖控制并预防 并发症和过早死亡。然而，持续的自我护理仍然具有高度的挑战性和高度的糖尿病 痛苦是很常见的。家庭成员和朋友可以加强或削弱患者的自我护理，许多 体验不知道如何最好地支持患者的自我护理努力的痛苦。尽管家人/朋友很有吸引力 支持人员可能是改善T2D结果的一种非常有效的方式，这一点很少被研究。致信地址 针对这些问题，我们开发了FAMS，一种包括电话辅导在内的手机传递的干预重点 改善社会支持和自我护理目标，并为患者提供短信支持，为他们的成人提供短信支持 支持人员。我们的初步研究表明，FAMS是可接受的、可行的，改善了患者得到的支持， 而且它可能会改善自我照顾能力。为了推动这一前景广阔的研究方向向前发展，我们现在提出如下建议 具体目标：目标1：扩大和改进FAMS。我们将在试点研究的基础上：(A)扩大FAMS的内容 除了饮食和体力活动外，还应包括量身定制的服药策略，(B)扩大其互动 支持人员的短信功能；(C)通过纳入循证证据，增强其目标设定要素 糖尿病教育材料。这将通过迭代的以用户为中心的测试来识别和解析内容来实现， 技术、研究流程和可用性问题。目的2：评价FAMS 2.0对T2D患者预后的影响。我们会 与334名患者-支持人员二人(约50%同居)进行随机对照试验，以评估扩大的 FAMS 2.0干预与注意控制(在T2D自理上打印材料和获取A1C结果)对长期- 长期血糖控制(主要结果)和心理社会健康(次要结果)。成人T2D和 基线A1c&>7.5%将通过中南临床数据研究网络确定和招募，并将招募 和一个支持人员在一起。我们将对种族/少数民族背景或社会经济水平较低的患者进行过多抽样。 状态。将在A1c和遇险定义的二项式地层内进行随机化。为期15个月的研究时间表 将包括9个月的干预期和6个月的随访，以评估持续的效果。我们还将评估 关键流程衡量标准包括培训忠诚度和短信回复率。目标3：探索FAMS 2.0对 支持人员。我们将评估分配给FAMS 2.0的支持人员是否在 他们自己的支持负担和心理社会幸福感要比那些分配给控制者的要多。目标4：检验假设 目标2和3中规定的效果的调节者和调解者。我们将评估对患者和 他们的支助人员因性别和二人同居而异，如果有针对性的心理和社会改善 行为机制调节患者和SPS结果的改善。完成这项拟议的研究将 确定这一高度新颖的干预措施是否改善了患有T2D的成年人及其支持人员的预后， 是谁，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，以 支持后续的实施研究。

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.