Using Mobile Technology to Reduce Stress in Caregivers of Persons with Dementia. A Scalable Solution to A Growing Problem

项目概要： 使用NIA 2年R21赠款机制，拟议研究将检查可行性（可接受性标志 和需求），以及基于消费者的移动的正念应用的概念证明， 情绪困扰和睡眠功能障碍的异质性，地理多样性，压力照顾者的个人， ADRD。Calm教授正念的基本原理，并使用基于证据的行为原则来吸引护理人员 持续练习（>10分钟/天），时间承诺最少，当他们方便时，不需要 旅行或训练有素的供应商。为了实现我们的目标，我们将进行单盲，试点，可行性，概念验证 CALM的RCT（12周，> 10分钟的每日练习）与注意力安慰剂时间和剂量匹配的播客 对照组（POD; 12周，每天>10分钟听力）。评估将在基线、项目后（12周）进行 之后）和20周随访时。护理人员还将完成每周评估。我们的团队有能力 在具有移动的应用程序（包括Calm）的具体经验的情况下进行本研究;干预开发， 可行性测试和临床试验; ADRD护理人员;招募国家，地理上不同的样本; R21赠款 提案在本R21的2年期结束时，我们将获得研究程序可行性的明确证据， 随机化、可接受性、可信度、依从性、保留和招募能力以及其减少 ADRD患者照顾者的压力。这项R21研究的结果将用于申请资金， 如果满足设定的基准（参见研究策略中的表格），则通过R 01进行有把握度的疗效RCT。目标是 传播和实施冷静，以减少所有人的压力，情绪障碍和睡眠困难 ADRD患者的护理人员。

PROJECT SUMMARY: Using the NIA 2 year R21 grant mechanisms, the proposed study will examine the feasibility (markers of acceptability and demand), and proof of concept of the consumer based mobile mindfulness application Calm in decreasing stress, emotional distress and sleep dysfunction in heterogeneous, geographically diverse, stress caregivers of individuals with ADRD. Calm teaches fundamentals of mindfulness and uses evidence based behavioral principles to engage caregivers in sustained practice (>10 min/day) with minimal time commitment, when it is convenient for them, without the need of travel or of a trained provider. To achieve our aims, we will conduct a single blind, pilot, feasibility, proof of concept RCT of CALM (12 weeks, > 10 minutes daily practice) versus an attention placebo time and dose matched podcast control (POD; 12 weeks, >10 minutes daily listening). Assessments will be conducted at baseline, post program (12 weeks later) and at 20 weeks follow-up. Caregivers will also complete weekly assessments. Our team is well positioned to conduct this study with specific experience with mobile applications including Calm; intervention development, feasibility testing and clinical trials; ADRD caregivers; recruitment of national, geographically diverse samples; R21 grant proposals. At the end of the 2-year period of this R21 we will have clear evidence of the feasibility of study procedures, randomization, acceptability, credibility, adherence, ability to retain and recruit as well as its proof of concepts in reducing stress in caregivers of people with ADRD. Results from this R21 study will be used to apply for funding to conduct a fully powered efficacy RCT, if set benchmarks are met (see Table in the Research Strategy), through an R01. The goal is dissemination and implementation of Calm to reduce stress, emotional dysfunction, and sleep difficulties among all caregivers of individuals with ADRD.