Latchem-Hastings Julie, Randell Elizabeth, Button Kate, Jones Fiona, Lowe Rachel, Dawes Helen, Wood Fiona, Davies Freya, Poile Vincent, O'Halloran Rhian, Stensland Barbara, Tallantyre Emma, Playle Rebecca, Edwards Adrian, Busse Monica
Centre for Trials Research, Cardiff University, 4th floor Neuadd Meirionnydd, Heath Park, Cardiff, UK.
School of Healthcare Sciences, Cardiff University, Ty Dewi Sant, Heath Park, Cardiff, UK.
Pilot Feasibility Stud. 2021 May 22;7(1):111. doi: 10.1186/s40814-021-00852-w.
We have co-designed a tailored blended physiotherapy intervention for people with progressive multiple sclerosis (PwPMS) who often struggle to access support for physical activity. Underpinned by self-management principles, the Lifestyle, Exercise and Activity Package for people with Multiple Sclerosis (LEAP-MS) intervention incorporates face-to-face or online physiotherapy coaching sessions with an accompanying online physical activity platform. The LEAP-MS platform is a multi-user system enabling user and physiotherapist to co-create activity plans. The LEAP-MS platform consists of an information and activity suite, interactive components enabling selection of exercises into an activity programme, goal setting and activity logging. The platform also facilitates online remote support from a physiotherapist through an embedded online messaging function. We aim to evaluate the LEAP-MS platform in a feasibility trial.
LEAP-MS will be evaluated within a single-arm feasibility study with embedded process evaluation. After registration and initial eligible screening, 21 participants will be required to complete baseline self-completion measures. This will be followed by an initial home-based or online coaching session with a physiotherapist (who has received tailored self-management and digital resource training) and access to the online intervention for an initial 3-month period. During this period, participants are given the option to request up to five further home-based or online physiotherapy coaching sessions. Follow-up questionnaires and semi-structured interviews will be administered 3 months after baseline with participants and intervention physiotherapists. The LEAP-MS platform will be available to participants for a further 3 months. Usage of the LEAP-MS platform will be tracked during the full 6-month period and final follow-up will be conducted 6 months after baseline.
Feasibility outcomes (recruitment, retention, intervention uptake and safety) will be reported. The process evaluation will be undertaken to identify possible mechanisms for any observed effects. The data will inform full-scale evaluations of this co-produced, blended physiotherapy intervention.
ClinicalTrials.gov , NCT03951181 . Registered 15 May 2019.
我们共同设计了一种针对进行性多发性硬化症患者（PwPMS）的量身定制的综合物理治疗干预措施，这类患者在获取体育活动支持方面常常面临困难。基于自我管理原则，针对多发性硬化症患者的生活方式、运动与活动套餐（LEAP-MS）干预措施融合了面对面或在线物理治疗辅导课程以及配套的在线体育活动平台。LEAP-MS平台是一个多用户系统，能让用户和物理治疗师共同制定活动计划。LEAP-MS平台由一个信息与活动套件、交互式组件组成，这些组件可将锻炼项目选入活动计划、设定目标并记录活动情况。该平台还通过嵌入式在线消息功能促进物理治疗师提供在线远程支持。我们旨在通过一项可行性试验对LEAP-MS平台进行评估。
将在一项带有嵌入式过程评估的单臂可行性研究中对LEAP-MS进行评估。在注册和初步合格筛选后，21名参与者将被要求完成基线自我完成测量。随后将与一名物理治疗师（该治疗师已接受量身定制的自我管理和数字资源培训）进行首次居家或在线辅导课程，并在最初3个月内使用在线干预措施。在此期间，参与者可选择请求最多另外五次居家或在线物理治疗辅导课程。在基线后3个月，将对参与者和干预物理治疗师进行随访问卷调查和半结构化访谈。LEAP-MS平台将再向参与者开放3个月。将在整个6个月期间跟踪LEAP-MS平台的使用情况，并在基线后6个月进行最终随访。
将报告可行性结果（招募、留存、干预措施采用情况和安全性）。将进行过程评估以确定任何观察到的效果的可能机制。这些数据将为对这种共同生产的综合物理治疗干预措施的全面评估提供信息。
ClinicalTrials.gov，NCT03951181。2019年5月15日注册。
