PDF(Pubmed)
Abstract：
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: German Clinical Trials Register (DRKS) DRKS00032667 (14/09/2023); Retrospectively registered.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: German Clinical Trials Register (DRKS) DRKS00032667 (14/09/2023); Retrospectively registered.
摘要：
背景：许多多发性硬化症（pwMS）患者希望了解健康行为如何变化（例如，饮食调整，身体活动,改善压力管理)可能有助于他们控制疾病。先前的研究表明，某些健康行为的改变可以改善生活质量(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措施，因为它们具有可访问性和灵活性。数字健康应用程序“levidex”旨在通过向pwMS提供基于证据的患者信息和认知行为治疗技术来促进健康行为改变。通过这样做,levidex旨在改善QoL和MS症状，如疲劳和心理健康。
目的：先前的研究报道了levidex的发展；这项非随机试点研究检查了levidex在中度至重度残疾的pwMS中的可行性（实用性和可接受性）。此外，干预对赋权的影响，压力管理，和相关的健康行为(例如，饮食行为，身体活动)进行了探索。
方法：levidex最初是在诊断后的第一年为新诊断的pwMS开发的，并最终进行了修改，以提供中度至重度残疾的pwMS。扩展残疾状态量表在3.5至7.5之间且疾病持续时间超过一年的参与者（n=43）有资格参加。干预在六个月的时间内使用，测量时间点在基线，3月和6月。
结果：在完成6个月干预期的38名参与者中，18个（47.4％）完成了所有16个模块，9个（23.7％）达到了13-16个模块，这是levidex的长期维护部分。参与者在实用性和可接受性方面对levidex给予了积极评价，并且只有很少的批评意见，例如包括更多适合患有严重障碍的参与者的体育锻炼常规建议。次要终点数据显示无显著变化。
结论：这项初步研究为levidex的实用性和可接受性提供了证据，一种数字健康应用程序，旨在促进中度至重度残疾的pwMS的健康行为改变。需要具有较长随访期的足够动力的随机对照研究，以阐明levidex在中度至重度残疾的pwMS中的益处。
背景：德国临床试验注册（DRKS）DRKS00032667（14/09/2023）；回顾性注册。
目的：先前的研究报道了levidex的发展；这项非随机试点研究检查了levidex在中度至重度残疾的pwMS中的可行性（实用性和可接受性）。此外，干预对赋权的影响，压力管理，和相关的健康行为(例如，饮食行为，身体活动)进行了探索。
方法：levidex最初是在诊断后的第一年为新诊断的pwMS开发的，并最终进行了修改，以提供中度至重度残疾的pwMS。扩展残疾状态量表在3.5至7.5之间且疾病持续时间超过一年的参与者（n=43）有资格参加。干预在六个月的时间内使用，测量时间点在基线，3月和6月。
结果：在完成6个月干预期的38名参与者中，18个（47.4％）完成了所有16个模块，9个（23.7％）达到了13-16个模块，这是levidex的长期维护部分。参与者在实用性和可接受性方面对levidex给予了积极评价，并且只有很少的批评意见，例如包括更多适合患有严重障碍的参与者的体育锻炼常规建议。次要终点数据显示无显著变化。
结论：这项初步研究为levidex的实用性和可接受性提供了证据，一种数字健康应用程序，旨在促进中度至重度残疾的pwMS的健康行为改变。需要具有较长随访期的足够动力的随机对照研究，以阐明levidex在中度至重度残疾的pwMS中的益处。
背景：德国临床试验注册（DRKS）DRKS00032667（14/09/2023）；回顾性注册。
