Juckett Lisa A, Joshi Shivam, Hyer J Madison, Hariharan Govind, Thomas Kali S, Sathya Tejeswini Siva, Howard Mequeil L, Bunck Leah E, Rowe Melinda L, Devier Andrea, Parrett Kelly
School of Health and Rehabilitation Sciences, The Ohio State University, 453 West 10 th Avenue, Columbus, OH, 43210, USA.
Center for Biostatistics, The Ohio State University Wexner Medical Center, 1645 Neil Avenue, Columbus, OH, 43210, USA.
BMC Geriatr. 2025 May 10;25(1):325. doi: 10.1186/s12877-025-06008-2.
Older adults increasingly prefer to age in place, but health and safety risks often threaten this independence. Home delivered meals, a key service under the Older Americans Act, provide essential nutritional support to homebound older adults, the majority of whom are at elevated risk for fall-related morbidity and mortality. Given the complex health conditions of homebound older adults, we conducted a feasibility randomized controlled trial (RCT) to evaluate our methods for testing four different service models designed to help reduce fall risk among home delivered meal recipients: (1) meals alone; (2) meals + registered dietitian nutritionist (RDN) services; (3) meals + occupational therapy (OT) services; or (4) meals + RDN + OT services. Findings will inform protocol modifications for our definitive RCT to improve fall-related outcomes among this population.
A four-arm, parallel-group feasibility RCT was conducted with one home delivered meal agency in the Midwest United States. Participants were eligible to participate if they were over 60 years old, were able to receive meals from our partner agency, had one diet-related health condition, and were at risk for falling. Feasibility outcomes included study eligibility, recruitment, retention, fidelity to RDN and OT services, and service acceptability.
Of 442 screened clients, 31% were eligible for participation, and 41% of eligible individuals were recruited (N = 56). Retention at three months was 79%. Fidelity rates were 84.5% for RDN services and 90.2% for OT services. Participants expressed high satisfaction with meal convenience and staff interactions but noted areas for improvement, including meal taste and inconsistent meal deliveries (e.g., timeliness; receiving correct meals).
The study identified several barriers to scaling this trial, including restrictive eligibility criteria and recruitment challenges. Protocol modifications for the definitive trial include broader eligibility, expanded recruitment areas, and increased flexibility in meal selection. Randomization procedures will also be adjusted to account for participants from the same household. This feasibility trial demonstrates the potential for integrating RDN and OT services into home delivered meal programs to address recipients' fall-related needs.
Clinicaltrials.gov; NCT06059404; 22/09/2023.
老年人越来越倾向于居家养老,但健康和安全风险常常威胁到这种独立性。上门送餐是《老年人法案》规定的一项关键服务,为居家老年人提供必要的营养支持,其中大多数人因跌倒相关的发病率和死亡率处于较高风险。鉴于居家老年人的健康状况复杂,我们进行了一项可行性随机对照试验(RCT),以评估我们测试四种不同服务模式的方法,这些模式旨在帮助降低上门送餐接受者的跌倒风险:(1)仅送餐;(2)送餐 + 注册营养师(RDN)服务;(3)送餐 + 职业治疗(OT)服务;或(4)送餐 + RDN + OT服务。研究结果将为我们确定性RCT的方案修改提供信息,以改善该人群与跌倒相关的结局。
在美国中西部的一家上门送餐机构进行了一项四臂平行组可行性RCT。参与者如果年龄超过60岁、能够从我们的合作机构接受送餐、有一种与饮食相关的健康状况且有跌倒风险,则有资格参与。可行性结果包括研究资格、招募、留存、对RDN和OT服务的依从性以及服务可接受性。
在442名筛查的客户中,31%有资格参与,41%的符合条件个体被招募(N = 56)。三个月时的留存率为79%。RDN服务的依从率为84.5%,OT服务的依从率为90.2%。参与者对送餐便利性和工作人员互动表示高度满意,但也指出了需要改进的方面,包括饭菜口味和送餐不一致(如及时性;收到正确的饭菜)。
该研究确定了扩大这项试验规模的几个障碍,包括严格的资格标准和招募挑战。确定性试验的方案修改包括更广泛的资格、扩大招募区域以及增加饭菜选择的灵活性。随机化程序也将进行调整,以考虑来自同一家庭的参与者。这项可行性试验证明了将RDN和OT服务整合到上门送餐计划中以满足接受者与跌倒相关需求的潜力。
Clinicaltrials.gov;NCT06059404;2023年9月22日。