An Online Lifestyle Modification Course for People With MS: a Randomised Controlled Trial of Course Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 945
- 试验地点
- 2
- 主要终点
- Change in mental health-related quality of life from baseline to 6- 12- and 30-month follow-up
研究概览
简要总结
Lifestyle factors are known to affect the progression of multiple sclerosis (MS). Studies of participants with MS attending an evidence-based lifestyle modification program, delivered via face-to-face workshops, have demonstrated improved mental and physical health, reduced relapse rate and improved quality of life over 3 years follow up, and that behaviour change was feasible and sustainable. However, the face-to-face modality of this educational intervention is resource intensive, and accessibility may be impeded by geography, cost, and MS-specific factors such as illness, fatigue, and disability. Furthermore, the COVID-19 pandemic has highlighted the unpredictable ability to travel and the importance of flexibility of health-related education.
The Neuroepidemiology Unit at the University of Melbourne has developed the Multiple Sclerosis Online Course (MSOC) to deliver a widely accessible and user-friendly educational tool for people with MS. The course aims to deliver the best available evidence regarding lifestyle-related risk factors in the development and progression of MS and behaviour modification to improve health outcomes.
Two forms of the course were developed:
- an intervention course delivering evidence-based information regarding modifiable lifestyle related risk factors implicated in disease progression; and
- a standard-care course, similar in format and presentation, but containing general information sourced from standard MS websites. Both courses have seven modules delivered over six weeks.
A feasibility study involving the delivery of the intervention and standard-care course was conducted from April to June 2021. The study assessed the primary outcomes of attrition in both intervention and standard-care arm. Secondary outcomes assessed assessed learnability, accessibility, and desirability via a Likert scale follow-up survey. A qualitative analysis examining motivation, expectations and outcomes was also conducted. Tertiary outcomes assessed the completion of the baseline surveys, a requirement to enter the course. Based on the feasibility study, the investigators have modified recruitment strategies, functionality, and the community forum aspects of the course. Investigators now aim to test the effectiveness of the intervention arm of the course versus the standard-care arm in a larger randomised controlled trial.
Objective:
To prospectively examine whether an MS Online intervention course (intervention arm) can deliver an evidence-based educational intervention that results in behaviour change which can be sustained and translated into improved health outcomes for people with MS, and whether these effects are superior to the MS Online standard-care course (control arm).
Participants who are 18 or older, diagnosed with multiple sclerosis by a doctor are welcome to join our study.
The online course will run for 6 weeks. During this time, there are no formal assessments or minimum time investment required, which means participants are free to navigate the course as they see fit.
Prior to commencing the study, participants will be asked fill-out a survey about their health (e.g., fatigue) and lifestyle (e.g., diet) and will be asked to fill this out again during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to read, write, and speak English;
- •Be 18 years old or over;
- •Have a confirmed diagnosis of relapsing-remitting MS by a neurologist;
- •Be able to access the internet and be able to view sessions.
排除标准
- •Experiencing any serious co-morbid chronic illness or neurological illness/injury other than MS that would threaten regular participation or significantly affect the outcome measures in its own right, such as motor neurone disease or stroke, as determined by the study investigators;
- •Currently participating in another study or self-management program involving modification of lifestyle.
结局指标
主要结局
Change in mental health-related quality of life from baseline to 6- 12- and 30-month follow-up
时间窗: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
Health-related quality of life will be measured using the Multiple Sclerosis Quality of Life survey (MSQOL-54)(Vickrey, Hays, Harooni, Myers, \& Ellison, 1995). The MSQoL-54 is a psychometrically validated, MS-specific, multi-dimensional inventory of patient-centered health status, and consists of 54 questions on items relevant to people with Multiple Sclerosis in the areas of health distress, sexual function, satisfaction with sexual function, overall quality of life, cognitive function, energy, and pain and social function. A physical and a mental dimension underlie the MSQOL-54: the Physical Health Composite (PHC) and Mental Health Composite (MHC). MHC scores range from 0 to 100, where higher values indicate better mental quality of life. Changes in MHC scores (from baseline to 6- 12- and 30-month follow-up) will be assessed and compared between participants in the intervention and standard care groups.
Change in physical health-related quality of life from baseline to 6- 12- and 30-month follow-up
时间窗: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
Health-related quality of life will be measured using the Multiple Sclerosis Quality of Life survey (MSQOL-54) (Vickrey, Hays, Harooni, Myers, \& Ellison, 1995). The MSQoL-54 is a psychometrically validated, MS-specific, multi-dimensional inventory of patient-centered health status, and consists of 54 questions on items relevant to people with Multiple Sclerosis in the areas of health distress, sexual function, satisfaction with sexual function, overall quality of life, cognitive function, energy, and pain and social function. A physical and a mental dimension underlie the MSQOL-54: the Physical Health Composite (PHC) and Mental Health Composite (MHC). PHC scores range from 0 to 100, where higher values indicate better physical quality of life. Changes in PHC scores (from baseline to 6- 12- and 30-month follow-up) will be assessed and compared between participants in the intervention and standard care groups.
次要结局
- Change in disability(Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up))
- Change in self-efficacy(Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up))
- Change in depression(Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up))
- Change in anxiety(Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up))
- Change in fatigue(Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up))