一项长期支持中风幸存者及其护理人员的干预措施：整群随机对照可行性试验（LoTS2Care）的结果

An intervention to support stroke survivors and their carers in the longer term: results of a cluster randomised controlled feasibility trial (LoTS2Care).

作者信息

Forster Anne, Ozer Seline, Brindle Richard, Barnard Lorna, Hardicre Natasha, Crocker Thomas F, Chenery Marie, Moreau Lauren, Wright Alan, Burton Louisa-Jane, Hartley Suzanne, Hulme Claire, Dawkins Bryony, Holloway Ivana, House Allan, Hewison Jenny, Farrin Amanda

机构信息

Academic Unit for Ageing and Stroke Research, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.

Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.

出版信息

Pilot Feasibility Stud. 2023 Mar 15;9(1):40. doi: 10.1186/s40814-023-01258-6.

DOI:10.1186/s40814-023-01258-6

PMID:36922866

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10015731/

Abstract

BACKGROUND

To address the limited provision of longer-term stroke care, we conducted a programme of research (LoTS2Care) to develop and test an intervention to form part of a replicable longer-term care strategy. New Start, a programme of facilitated self-management, was developed to be delivered at 6 months post-stroke by trained facilitators. Here, we report the findings from the final workstream of this programme, which aimed to evaluate the feasibility and acceptability of implementing a future definitive cluster randomised controlled trial of the developed intervention (New Start) to support stroke survivors and their carers in the longer term.

METHODS

A feasibility cluster randomised controlled trial was conducted in English and Welsh NHS stroke services. Stroke services (clusters) were randomised on a 1:1 basis to implement New Start or continue with usual care only. Community-dwelling stroke survivors between 4 and 6 months post-stroke were invited to participate in the trial by post. Outcome measures were collected via post at 3, 6 and 9 months after recruitment. Recruitment and follow-up rates, delivery and uptake of the intervention, data collection feasibility (including postal outcome measures of health and disability, mental well-being at 3, 6, and 9 months post-recruitment) and safety were assessed.

RESULTS

Ten stroke services were recruited. A total of 1127 stroke survivors were screened for participation, and 269 were registered (New Start, n = 145; usual care, n = 124). Retention was high with 239 (89%) stroke survivors being available for follow-up at 9 months, and high return rates of postal questionnaires were achieved (80.3% at 9 months). Intervention training was successfully delivered, and New Start was offered to 95.2% of trial participants in the intervention arm. Uptake was variable, however, ranging from 11.8 to 75.0%. There were no safety concerns.

CONCLUSIONS

Stroke service recruitment and longer-term stroke survivor postal recruitment and outcome data collection are feasible; however, refinement of intervention targeting and delivery is required prior to undertaking a definitive trial.

TRIAL REGISTRATION

ISRCTN38920246. Registered 22 June 2016 ( http://www.isrctn.com/ISRCTN38920246 ).

摘要

背景

为解决长期卒中护理供应有限的问题，我们开展了一项研究计划（LoTS2Care），以开发并测试一种干预措施，使其成为可复制的长期护理策略的一部分。“新起点”是一项促进自我管理的计划，由经过培训的协调员在卒中后6个月实施。在此，我们报告该计划最后一个工作流程的研究结果，其目的是评估对已开发的干预措施（“新起点”）开展未来确定性整群随机对照试验的可行性和可接受性，以便从长远角度支持卒中幸存者及其护理人员。

方法

在英格兰和威尔士的国民保健服务（NHS）卒中服务机构中进行了一项可行性整群随机对照试验。卒中服务机构（群组）按1:1的比例随机分配，以实施“新起点”计划或仅继续提供常规护理。通过邮寄方式邀请卒中后4至6个月的社区居住卒中幸存者参与试验。在招募后3、6和9个月通过邮寄方式收集结果指标。评估招募率和随访率、干预措施的实施和接受情况、数据收集的可行性（包括招募后3、6和9个月关于健康和残疾的邮寄结果指标、心理健康状况）以及安全性。

结果

招募了10个卒中服务机构。总共筛选了1127名卒中幸存者参与研究，269人登记（“新起点”组，n = 145；常规护理组，n = 124）。9个月时，239名（89%）卒中幸存者可进行随访，保留率较高，邮寄问卷的回收率也较高（9个月时为80.3%）。干预培训成功实施，干预组95.2%的试验参与者接受了“新起点”计划。然而，接受率各不相同，范围在11.8%至75.0%之间。未发现安全问题。