Feldman Penny H, McDonald Margaret V, Onorato Nicole, Stein Joel, Williams Olajide
Center for Home Care Policy & Research, Visiting Nurse Service of New York, 220 East 42nd Street, New York, NY, 10017, USA.
Department of Rehabilitation and Regenerative Medicine, Columbia University Vagelos College of Physicians and Surgeons, Department of Rehabilitation Medicine, Weill Cornell Medicine, New York-Presbyterian Hospital, 180 Ft. Washington Ave., Harkness Pavilion Room 1-165, New York, NY, 10032, USA.
Pilot Feasibility Stud. 2022 Jan 31;8(1):22. doi: 10.1186/s40814-022-00979-4.
Each year, approximately 100,000 individuals receive home health services after a stroke. Evidence has shown the benefits of home-based stroke rehabilitation, but little is known about resource-efficient ways to enhance its effectiveness, nor has anyone explored the value of leveraging low-cost home health aides (HHAs) to reinforce repetitive task training, a key component of home-based rehabilitation. We developed and piloted a Stroke Homehealth Aide Recovery Program (SHARP) that deployed specially trained HHAs as "peer coaches" to mentor frontline aides and help individuals recovering from stroke increase their mobility through greater adherence to repetitive exercise regimens. We assessed the feasibility of SHARP and its readiness for a full-scale randomized controlled trial (RCT). Specifically, we examined (1) the practicability of recruitment and randomization procedures, (2) program acceptability, (3) intervention fidelity, and (4) the performance of outcome measures.
This was a feasibility study including a pilot RCT. Target enrollment was 60 individuals receiving post-stroke home health services, who were randomized to SHARP + usual home care or usual care only. The protocol specified a 30-day intervention with four planned in-home coach visits, including one joint coach/physical therapist visit. The primary participant outcome was 60-day change in mobility, using the performance-based Timed Up and Go and 4-Meter Walk Gait Speed tests. Interviews with participants, coaches, physical therapists, and frontline aides provided acceptability data. Enrollment figures, visit tracking reports, and audio recordings provided intervention fidelity data. Mixed methods included thematic analysis of qualitative data and quantitative analysis of structured data to examine the intervention feasibility and performance of outcome measures.
Achieving the 60-participant enrollment target required modifying participant eligibility criteria to accommodate a decline in the receipt of HHA services among individuals receiving home care after a stroke. This modification entailed intervention redesign. Acceptability was high among coaches and participants but lower among therapists and frontline aides. Intervention fidelity was mixed: 87% of intervention participants received all four planned coach visits; however, no joint coach/therapist visits occurred. Sixty-day follow-up retention was 78%. However, baseline and follow-up performance-based primary outcome mobility assessments could be completed for only 55% of participants.
The trial was not feasible in its current form. Before progressing to a definitive trial, significant program redesign would be required to address issues affecting enrollment, coach/HHA/therapist coordination, and implementation of performance-based outcome measures.
ClinicalTrials.gov, NCT04840407 . Retrospectively registered on 9 April 2021.
每年约有10万人在中风后接受家庭健康服务。有证据表明基于家庭的中风康复具有益处，但对于提高其有效性的资源高效方法知之甚少，也没有人探索利用低成本家庭健康助理（HHA）来加强重复性任务训练的价值，而重复性任务训练是基于家庭康复的关键组成部分。我们开发并试点了中风家庭健康助理康复计划（SHARP），该计划将经过专门培训的HHA作为“同伴教练”，指导一线助理，并帮助中风康复者通过更严格地遵守重复性锻炼方案来提高活动能力。我们评估了SHARP的可行性及其开展全面随机对照试验（RCT）的准备情况。具体而言，我们考察了：（1）招募和随机化程序的实用性；（2）项目可接受性；（3）干预保真度；以及（4）结果测量指标的表现。
这是一项包括试点RCT的可行性研究。目标入组人数为60名接受中风后家庭健康服务的个体，他们被随机分为SHARP + 常规家庭护理组或仅接受常规护理组。该方案规定了为期30天的干预，计划进行4次上门教练探访，包括1次教练/物理治疗师联合探访。主要参与者结局指标是使用基于表现的计时起立行走测试和4米步行速度测试评估的60天活动能力变化。对参与者、教练、物理治疗师和一线助理的访谈提供了可接受性数据。入组数字、探访跟踪报告和录音提供了干预保真度数据。混合方法包括对定性数据的主题分析和对结构化数据的定量分析，以考察干预的可行性和结果测量指标的表现。
要实现60名参与者的入组目标，需要修改参与者资格标准，以适应中风后接受家庭护理的个体中HHA服务接受率的下降。这一修改需要重新设计干预措施。教练和参与者的可接受性较高，但治疗师和一线助理的可接受性较低。干预保真度参差不齐：87%的干预参与者接受了所有4次计划的教练探访；然而，没有进行教练/治疗师联合探访。60天随访时的留存率为78%。然而，仅55%的参与者能够完成基于表现的基线和随访主要结局活动能力评估。
该试验目前的形式不可行。在进行确定性试验之前，需要对项目进行重大重新设计，以解决影响入组、教练/HHA/治疗师协调以及基于表现的结局指标实施等问题。
ClinicalTrials.gov，NCT04840407。于2021年4月9日进行回顾性注册。
