Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
Research and Development Department, GAIA Group, Hamburg, Germany.
BMC Neurol. 2023 Oct 23;23(1):382. doi: 10.1186/s12883-023-03434-w.
Many persons with multiple sclerosis (pwMS) desire to learn how health behaviour changes (e.g., dietary adjustments, physical activity, improvements in stress management) might help them manage their disease. Previous research has shown that certain health behaviour changes can improve quality of life (QoL), fatigue and other MS outcomes. Digital health applications may be well suited to deliver relevant health behavioural interventions because of their accessibility and flexibility. The digital health application "levidex" was designed to facilitate health behaviour change by offering evidence-based patient information and cognitive-behavioural therapy techniques to pwMS. By doing so, levidex aims to improve QoL and MS symptoms such as fatigue and mental health.
A previous study reported on the development of levidex; this non-randomised pilot study examined the feasibility (practicability and acceptability) of levidex in pwMS with moderate to severe disability. Furthermore, the intervention's impact on empowerment, stress management, and relevant health behaviours (e.g., dietary behaviour, physical activity) was explored.
levidex was originally developed for newly diagnosed pwMS in the first year after diagnosis and eventually modified to offer access to pwMS with moderate to severe disability. Participants (n = 43) with an Expanded Disability Status Scale between 3.5 and 7.5 and a disease duration of more than one year were eligible to participate. The intervention was used over a period of six months with measurement time points at baseline, month 3 and month 6.
Out of 38 participants who completed the six-month intervention period, 18 (47.4%) completed all 16 modules and 9 (23.7%) reached modules 13-16, the long-term maintenance part of levidex. Participants rated levidex positively in terms of practicability and acceptability and had only few points of criticism such as to include more physical exercise routine suggestions suitable for participants with severe impairment. Data on secondary endpoints showed no significant changes.
This pilot study provided evidence for the practicability and acceptability of levidex, a digital health application designed to facilitate health behaviour change in pwMS with moderate to severe disability. Adequately powered randomised controlled studies with longer follow-up periods are needed to clarify the benefit of levidex in pwMS with moderate to severe disability.
German Clinical Trials Register (DRKS) DRKS00032667 (14/09/2023); Retrospectively registered.
许多多发性硬化症（pwMS）患者希望了解健康行为的改变（例如饮食调整、身体活动、改善压力管理）如何帮助他们控制疾病。先前的研究表明，某些健康行为的改变可以提高生活质量（QoL）、疲劳和其他 MS 结果。数字健康应用程序可能非常适合提供相关的健康行为干预，因为它们具有可及性和灵活性。数字健康应用程序“levidex”旨在通过为 pwMS 提供基于证据的患者信息和认知行为疗法技术来促进健康行为的改变。通过这种方式，levidex 旨在改善 QoL 和 MS 症状，如疲劳和心理健康。
先前的研究报告了 levidex 的开发情况；这项非随机试点研究检查了 levidex 在中重度残疾的 pwMS 中的可行性（实用性和可接受性）。此外，还探讨了干预措施对赋权、压力管理以及相关健康行为（例如饮食行为、身体活动）的影响。
levidex 最初是为新诊断的 pwMS 在诊断后第一年开发的，最终修改后可供中重度残疾的 pwMS 使用。符合条件的参与者（n=43）的扩展残疾状态量表（EDSS）介于 3.5 和 7.5 之间，且疾病持续时间超过一年。该干预措施在六个月的时间内使用，并在基线、第 3 个月和第 6 个月进行测量。
在完成六个月干预期的 38 名参与者中，18 名（47.4%）完成了所有 16 个模块，9 名（23.7%）完成了模块 13-16，这是 levidex 的长期维护部分。参与者对 levidex 的实用性和可接受性给予了积极评价，只有少数几点批评意见，例如纳入更适合严重残疾参与者的身体锻炼常规建议。次要终点数据没有显示出显著变化。
这项试点研究为数字健康应用程序 levidex 的实用性和可接受性提供了证据，该应用程序旨在促进中重度残疾的 pwMS 改变健康行为。需要进行足够样本量的随机对照研究，并进行更长时间的随访，以明确 levidex 在中重度残疾的 pwMS 中的获益。
德国临床试验注册（DRKS）DRKS00032667（2023 年 9 月 14 日）；回顾性注册。
