Reducing Burden in Care Partners of Community-Dwelling Persons with Dementia and Oropharyngeal Dysphagia

减轻社区居民痴呆症和口咽吞咽困难患者护理伙伴的负担

• 批准号: 10570435
• 负责人: Michael A Diefenbach
• 金额: $ 41.09万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10570435
• 关键词: Address; Affect; Alzheimer' s Disease; Alzheimer' s disease patient; Alzheimer' s disease related dementia; Behavioral; Caring; Cellular Phone; Communities; Competence; Consent; Data; Deglutition Disorders; Dementia; Diagnosis; Diet; Disease; Eating; Face; Feedback; Feeling; Female; Frustration; Gender; Genetic Transcription; Goals; Health; Home Page; Hospitalization; Hospitals; Informal Social Control; Intervention; Interview; Knowledge; Lead; Link; Liquid substance; Malignant neoplasm of urinary bladder; Mediating; Mediator; Medical Care Team; Methods; Online Systems; Oropharyngeal Dysphagia; Outcome; Participant; Patient-Focused Outcomes; Patients; Persons; Phase; Quality of life; Randomized; Randomized, Controlled Trials; Reporting; Research; Resources; Self Efficacy; Severities; Structure; Syndrome; System; Technology; Testing; Treatment Efficacy; United States National Institutes of Health; Writing; age related; caregiving; coping; design; effective intervention; efficacy evaluation; expectation; experience; feeding; hospital care; human old age (65+); improved; improved outcome; intervention effect; multidisciplinary; pilot test; primary outcome; recruit; secondary outcome; skills; stress management; success; tool; treatment as usual; usability; web-based tool

We propose an NIH Stage I (R61) study to adapt, refine, and pilot test a Web-based Care Partner Tool for Feeding in Dysphagia (WeCareToFeedDysphagia), followed by an NIH Stage IV (R33) full-scale, 24-month, randomized controlled trial (RCT), to determine the efficacy of WeCareToFeedDysphagia for reducing burden in care partners of community-dwelling persons with Alzheimer’s disease (AD) and AD-related dementias (AD/ADRD), diagnosed with oropharyngeal dysphagia (OD) during hospitalization. OD, a devastating syndrome that affects nearly 90% of hospitalized patients with AD/ADRD, is a significant predictor of care- partner burden, which, in turn, leads to poor care-partner and patient outcomes (e.g., quality of life, QoL). Our preliminary data indicate that, upon hospital discharge, care partners of patients with AD/ADRD face dramatic and persistent unmet OD-related caregiving needs: A. knowledge deficits; B. unrealistic management expectations; C. patient QoL considerations; D. inability to cope with patient’s frustration/refusal to eat dysphagia diets; and E. lack of competencies/skills. The overall goal of this proposal is to reduce burden in care partners of community-dwelling persons with AD/ADRD and OD using a single-component, easily administered, intervention that addresses unmet OD-related caregiving needs. Guided by a self-regulation theoretical framework, WeCareToFeedDysphagia will use written and video content, care-partner testimonials, frequently asked questions, and resource links, to: A. provide accurate information (e.g., dysphagia diets); B. set realistic expectations; C. identify/support feeding goals (QoL considerations); D. acknowledge/support care-partner feelings; and E. provide competencies/skills for OD management. The R61 phase will adapt, refine, and pilot test WeCareToFeedDysphagia to reduce care-partner burden by: adapting our existing web- based tool by incorporating stakeholder input (Aim 1), resulting in WeCareToFeedDysphagia; refining the tool through usability/acceptability testing (Aim 2); and conducting a pilot RCT (N=60) to determine the preliminary efficacy of WeCareToFeedDysphagia to reduce care-partner burden, as well as the feasibility of a subsequent full-scale RCT (Aim 3). We will assess care partner reported outcomes using technology (e.g., smartphones): 3-month post-hospital care-partner burden (primary outcome) and QoL (secondary outcome). The go/no-go criteria for the full-scale RCT is defined as: feasibility as ≥50% consented, ≤20% attrition at 3 months, and ≥80% tool engagement; and preliminary efficacy as effect size of ≥0.3 for reducing care-partner burden. The R33 phase will determine the efficacy of WeCareToFeedDysphagia to reduce care-partner burden by: conducting a 24-month, full-scale RCT (N=406) at 11 diverse Northwell Health hospitals (Aim 4) and conducting moderator and mediator analyses to examine the impact on intervention efficacy (Aim 5). The proposal directly responds to NIA’s strategic direction to develop effective interventions to reduce the burden of age-related diseases and improve QoL for persons with AD/ADRD and their care partners.

我们提出了一项NIH第一阶段（R61）研究，以适应，完善和试点测试基于网络的护理合作伙伴工具， 吞咽困难喂养（WeCareToFeedDysphagia），随后是NIH第IV阶段（R33）全规模，24个月， 随机对照试验（RCT），旨在确定WeCareToFeedDysphagia减轻负担的疗效 在社区居住的阿尔茨海默病（AD）和AD相关痴呆患者的护理伙伴中， (AD/ADRD），住院期间诊断为口咽吞咽困难（OD）。一场毁灭性的 影响近90%的AD/ADRD住院患者的综合征，是护理的重要预测因素， 伴侣负担，这反过来又导致护理伴侣和患者结果不佳（例如，生活质量（Quality of Life，QoL）我们 初步数据表明，在出院时，AD/ADRD患者的护理伙伴面临着巨大的风险， 和持久未得到满足的与消耗臭氧层物质有关的替代需求：A.知识缺陷; B.非现实管理 期望; C.患者QoL考虑因素; D.无法应对患者的沮丧/拒绝进食 Dysphagia diets; E.缺乏能力/技能。该提案的总体目标是减轻 社区居住的AD/ADRD和OD患者的护理伙伴使用单一组件， 管理的干预措施，解决未满足的与消耗臭氧层物质有关的需求。以自律为导向 理论框架，WeCareToFeedDysphagia将使用书面和视频内容，护理合作伙伴的推荐， 常见问题和资源链接，到：A。提供准确的信息（例如，吞咽困难饮食）; B. 设定现实的期望; C.确定/支持喂养目标（QoL考虑）; D.承认/支持 照顾伴侣的感觉;和E.提供OD管理的能力/技能。R61阶段将适应， 完善并试点测试WeCareToFeed吞咽困难，通过调整我们现有的网络来减轻护理伙伴的负担 通过纳入利益相关者的输入（目标1），基于工具，导致WeCareToFeed吞咽困难;完善工具 通过可用性/可接受性测试（目标2）;并进行试点RCT（N = 60），以确定初步 WeCareToFeedDysphagia减轻护理伴侣负担的有效性，以及后续治疗的可行性 全面RCT（目标3）。我们将使用技术评估护理伙伴报告的结果（例如，智能手机）： 3-月的住院后护理-伴侣负担（主要结局）和QoL（次要结局）。go/no go 全规模RCT的标准定义为：可行性为≥ 50%的知情同意，3个月时的脱落率≤ 20%，以及 工具参与度≥ 80%;减少护理伙伴负担的初步疗效（效应量≥ 0.3）。的 R33阶段将通过以下方式确定WeCareToFeedDysphagia减轻护理伴侣负担的疗效： 在11家不同的Northwell Health医院（目标4）进行为期24个月的全面RCT（N = 406）， 进行调节和中介分析，以检查对干预效果的影响（目标5）。的 提案直接响应了NIA的战略方向，即制定有效的干预措施，以减轻 年龄相关疾病，并改善AD/ADRD患者及其护理伙伴的QoL。