Gadbois Emily A, Bunker Jennifer N, Hilgeman Michelle, Shield Renee, McAuliff Kathleen E, Mills Whitney, Thomas Kali
Brown University School of Public Health, Providence, RI, USA.
Research and Development Service, Tuscaloosa Veterans Affairs Medical Center, Tuscaloosa, AL, USA.
Pilot Feasibility Stud. 2023 Apr 22;9(1):65. doi: 10.1186/s40814-023-01302-5.
Among older adults, food insecurity is associated with poor health status and health outcomes; people living with dementia (PLWD) are at increased risk for insecurity. Approaches to addressing food insecurity among homebound older adults include two modes of home-delivered meals: (1) meals delivered daily to participants' homes by a volunteer or paid driver who socializes with the client or (2) frozen meals that are mailed to participants' homes. Research has not examined benefits of these meals for PLWD or their caregivers nor compared the effectiveness of these two approaches in reducing food insecurity. The objective of this study was to test the processes for recruiting and engaging in qualitative research with PLWD and caregivers in an effort to understand the context, implementation, and mechanisms of impact by which relationships between meal delivery and outcomes may be achieved in preparation for a larger, follow-on study.
This is a qualitative sub-study of a pilot, multisite, two-arm pragmatic feasibility trial comparing the effect of two modes of meal delivery on nursing home placement among 243 PLWD. In this sub-study, we tested recruitment and enrollment procedures and piloted interview guides among a subset of participants and caregivers.
We recruited and conducted interviews with nine PLWD and seven caregivers. In testing the informed consent process, all participants were able to consent to be interviewed, and PLWD all demonstrated capacity to consent. We successfully used a cognitive screener to obtain scores of cognitive impairment for PLWD and observed scores indicating a broad range of function. Our interview guides successfully resulted in information about the context, implementation, and mechanisms of impact for meal delivery during the pilot.
In addition to establishing feasibility for the future trial, the substantive findings identified through the qualitative interviews provide an initial understanding of the contextual factors for meal delivery and the potential mechanisms of impact across meal delivery types that warrant further examination in a full-scale trial. Findings from our study provide crucial pilot data to support a follow-on trial to understand how to address food insecurity among PLWD.
ClinicalTrials.gov TRIAL REGISTRATION: NCT04850781 DATE OF REGISTRATION: April 20, 2021, retrospectively registered https://clinicaltrials.gov/ct2/show/NCT04850781.
在老年人中，粮食不安全与健康状况不佳和健康结果相关；患有痴呆症的人（PLWD）面临粮食不安全的风险更高。解决居家老年人粮食不安全问题的方法包括两种上门送餐模式：（1）由志愿者或付费司机每天将餐食送到参与者家中，并与客户交流；（2）将冷冻餐食邮寄到参与者家中。研究尚未考察这些餐食对PLWD或其护理人员的益处，也未比较这两种方法在减少粮食不安全方面的有效性。本研究的目的是测试招募PLWD及其护理人员并参与定性研究的过程，以便了解送餐与结果之间关系得以实现的背景、实施情况和影响机制，为更大规模的后续研究做准备。
这是一项定性子研究，是一项试点、多地点、双臂实用可行性试验的一部分，该试验比较了两种送餐模式对243名PLWD进入养老院安置情况的影响。在这项子研究中，我们测试了招募和入组程序，并在一部分参与者和护理人员中试用了访谈指南。
我们招募了9名PLWD和7名护理人员并进行了访谈。在测试知情同意过程时，所有参与者都能够同意接受访谈，并且PLWD都表现出同意的能力。我们成功地使用了认知筛查工具来获取PLWD的认知障碍评分，并观察到分数表明其功能范围广泛。我们的访谈指南成功地获取了有关试点期间送餐的背景、实施情况和影响机制的信息。
除了为未来的试验确立可行性外，通过定性访谈确定的实质性发现初步了解了送餐的背景因素以及不同送餐类型的潜在影响机制，这些值得在全面试验中进一步研究。我们研究的结果提供了关键的试点数据，以支持后续试验，以了解如何解决PLWD的粮食不安全问题。
ClinicalTrials.gov 试验注册号：NCT04850781 注册日期：2021年4月20日，追溯注册 https://clinicaltrials.gov/ct2/show/NCT04850781
