Forster Anne, Hartley Suzanne, Barnard Lorna, Ozer Seline, Hardicre Natasha, Crocker Tom, Fletcher Marie, Moreau Lauren, Atkinson Ross, Hulme Claire, Holloway Ivana, Schmitt Laetitia, House Allan, Hewison Jenny, Richardson Gillian, Farrin Amanda
Academic Unit of Elderly Care and Rehabilitation, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.
Trials. 2018 Jun 11;19(1):317. doi: 10.1186/s13063-018-2669-5.
Despite the evidence that many stroke survivors report longer term unmet needs, the provision of longer term care is limited. To address this, we are conducting a programme of research to develop an evidence-based and replicable longer term care strategy. The developed complex intervention (named New Start), which includes needs identification, exploration of social networks and components of problem solving and self-management, was designed to improve quality of life by addressing unmet needs and increasing participation.
METHODS/DESIGN: A multicentre, cluster randomised controlled feasibility trial designed to inform the design of a possible future definitive cluster randomised controlled trial (cRCT) and explore the potential clinical and cost-effectiveness of New Start. Ten stroke services across the UK will be randomised on a 1:1 basis either to implement New Start or continue with usual care only. New Start will be delivered by trained facilitators and will be offered to all stroke survivors within the services allocated to the intervention arm. Stroke survivors will be eligible for the trial if they are 4-6 months post-stroke and residing in the community. Carers (if available) will also be invited to take part. Invitation to participate will be initiated by post and outcome measures will be collected via postal questionnaires at 3, 6 and 9 months after recruitment. Outcome data relating to perceived health and disability, wellbeing and quality of life as well as unmet needs will be collected. A 'study within a trial' (SWAT) is planned to determine the most acceptable format in which to provide the postal questionnaires. Details of health and social care service usage will also be collected to inform the economic evaluation. The feasibility of recruiting services and stroke survivors to the trial and of collecting postal outcomes will be assessed and the potential for effectiveness will be investigated. An embedded process evaluation (reported separately) will assess implementation fidelity and explore and clarify causal assumptions regarding implementation.
This feasibility trial with embedded process evaluation will allow us to gather important and detailed data regarding methodological and implementation issues to inform the design of a possible future definitive cRCT of this complex intervention.
ISRCTN38920246 . Registered 22 June 2016.
尽管有证据表明许多中风幸存者报告了长期未得到满足的需求，但长期护理的提供却很有限。为解决这一问题，我们正在开展一项研究计划，以制定基于证据且可复制的长期护理策略。所开发的综合干预措施（名为“新起点”），包括需求识别、社会网络探索以及问题解决和自我管理的组成部分，旨在通过满足未得到满足的需求和增加参与度来提高生活质量。
方法/设计：一项多中心、整群随机对照可行性试验，旨在为未来可能的确定性整群随机对照试验（cRCT）的设计提供信息，并探索“新起点”的潜在临床和成本效益。英国的10个中风服务机构将按1:1的比例随机分配，要么实施“新起点”，要么仅继续常规护理。“新起点”将由经过培训的协调员提供，并将提供给分配到干预组的服务机构内的所有中风幸存者。中风幸存者如果在中风后4至6个月且居住在社区，将有资格参加试验。照顾者（如果有）也将被邀请参与。参与邀请将通过邮寄发起，结果测量将在招募后3个月、6个月和9个月通过邮寄问卷收集。将收集与感知健康和残疾、幸福感和生活质量以及未得到满足的需求相关的结果数据。计划进行一项“试验中的研究”（SWAT），以确定提供邮寄问卷的最可接受格式。还将收集健康和社会护理服务使用情况的详细信息，以为经济评估提供依据。将评估招募服务机构和中风幸存者参加试验以及收集邮寄结果的可行性，并调查有效性的潜力。一项嵌入式过程评估（单独报告）将评估实施的保真度，并探索和阐明关于实施的因果假设。
这项带有嵌入式过程评估的可行性试验将使我们能够收集有关方法和实施问题的重要详细数据，以为未来可能的关于这种综合干预措施的确定性cRCT的设计提供信息。
ISRCTN38920246。2016年6月22日注册。
