Development and Evaluation of a Web-based Lifestyle Intervention for EmPOWERment in Early Multiple Sclerosis (POWER@MS1) - a Randomized Controlled Trial and Mixed-methods Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Occurrence of new lesions on T2-weighted images on MRI scans
研究概览
简要总结
This randomized controlled trial with an accompanying process evaluation investigates the hypothesis that behavioural and web-based information on immunotherapy decisions, disease management and lifestyle can change patient behaviour resulting in reduced inflammatory disease activity in multiple sclerosis.
详细描述
After a multiple sclerosis (MS) diagnosis, uncertainty and psychological stress may have a negative effect on the disease course, while psychological counselling may reduce inflammatory activity. Therefore, especially newly diagnosed patients require intensive and individual support to deal with the disease and to initiate lifestyle changes. This is hardly available in standard care. Systematic, evidence-based patient information on the value of lifestyle change is not available either.
POWER@MS1 aims to encourage patients with MS to find the best way of dealing with the disease on the basis of evidence-based patient information (EBPI) and a complex behaviour change intervention. The platform will serve as a disease accompanying empowerment programme. Various modules will be provided to accompany patients with MS (pwMS) at an early stage of the disease. The multicomponent intervention will offer comprehensive support after diagnosis, which includes, firstly, an immunotherapy decision-support programme aligned with principles of shared decision-making (SDM), and, secondly, a behaviour-change intervention promoting disease management and lifestyle habits over a period of one year. Ideally, POWER@MS1 leads to a more targeted immunotherapy start, and consequently to better adherence and optimization of a preventive effective lifestyle.
Primary objective:
To determine if a web-based behavioural intervention on immunotherapy decision making, disease management, and lifestyle can reduce the inflammatory disease activity in MS (a relapse or - as a surrogate for inflammatory disease activity - new T2 lesions on magnetic resonance imaging (MRI)).
Secondary objectives:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be conducted as an investigator blinded trial and participating physicians as well as MS centres in general will not be provided with any information about the group assignment. Randomisation will take place only after baseline documentation. Blinding of the trial participants is pursued, but only possible to a limited extent. Furthermore, it cannot be prevented that patients discuss the intervention contents with their physician. Thus, participants and neurologist might realize their participation in the intervention group. While blinding in behavioural interventions is virtually not possible, the only strategy to increase similarity of groups is to have an active control group which we aim for with the optimized standard care group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •clinically isolated syndrome (CIS), suspected or confirmed MS for less than 12 months
- •at least two MS-typical lesions on T2-weighted images on MRI scans
- •MS typical cerebrospinal fluid (CSF) finding with detection of oligoclonal bands
- •access to the internet and ability to use websites
排除标准
- •corticosteroid therapy within 4 weeks prior to study inclusion
- •substantial psychiatric disorder (based on clinical impression)
- •severe cognitive deficit affecting information uptake (based on clinical impression)
- •pregnancy
- •claustrophobia
研究组 & 干预措施
EBBC programme
Participants in the intervention group will receive access to evidence-based patient information (EBPI) about lifestyle factors in MS combined with a complex behaviour change programme (EBBC programme), an online tool that was developed in line with principles of patient empowerment and cognitive behavioural therapy (CBT) approaches, including acceptance and mindfulness oriented techniques.
干预措施: EBBC programme (Behavioral)
Control group programme
Participants randomized to the active control group will receive access to an information platform with optimized standard care consisting of information compiled from the German Multiple Sclerosis Society (DMSG) information material to reflect current practice.
干预措施: Control group programme (Behavioral)
结局指标
主要结局
Occurrence of new lesions on T2-weighted images on MRI scans
时间窗: Change in the number of lesions on T2-weighted images from immediately after patient inclusion (month 0), to month 3, 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion
As a surrogate for inflammatory disease activity, new T2 lesions will be assessed in MRI. MRI protocol: Localizer, 3D FLAIR sagittal e.g. 3x3mmm, 3D image T1w native sagittal, 1-3mm, PD/T2w axial 3mm, protocol duration approx. 20 min.
Time to a second relapse
时间窗: Change in relapse status from baseline (no endpoint), to month 1, 3, 6, 12, 18 (follow-up), and 24 (follow-up) after patient inclusion
Duration of complaints/impairment, relapse symptoms (worsened or newly occurred), degree of impairment due to the relapse and degree of certainty with regard to the classification of the worsening as a relapse.
次要结局
- 24-h dietary recall myfood24(Baseline and month 12 after patient inclusion, in each case three times within two to three weeks (two weekdays and one weekend day))
- Risk Knowledge (RiKno10)(Month 3 after patient inclusion)
- Control Preference Scale (CPS)(Month 12 after patient inclusion, as well as after reaching the primary endpoint)
- Immunotherapy Decision Satisfaction Questionnaire(After reaching the primary endpoint)
- Immunotherapy Status Questionnaire(Baseline (no endpoint), month 1, 3, 6, 12, 18 (follow-up), 24 (follow-up) after patient inclusion)
- Coping self-efficacy (CSE) scale(Baseline and month 12 after patient inclusion)
- Impairment in the Expanded Disability Status Scale (EDSS)(Baseline and month 12 after patient inclusion)
- Patient Activation Measure (PAM)(Baseline and month 12 after patient inclusion)
- Changes in Perceived Empowerment Questionnaire(Month 12 after patient inclusion)
- Credibility/Expectancy Questionnaire(4 weeks after patient inclusion (month 1))
- Readiness to Change (stage assessment) based on the Health Action Process Approach (HAPA)(Baseline, month 3 and 12 after patient inclusion)
- Hamburg Quality of life in MS Scale (HAQUAMS)(Baseline and month 12 after patient inclusion)
- EQ-5D(Baseline, month 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion)
- Questionnaire of Healthy Diet (QHOD2), adapted version of the Mediterranean Diet Screener (aMDS)(Baseline, month 3 and 12 after patient inclusion)
- Hospital anxiety and distress scale (HADS)(Baseline and month 12 after patient inclusion)
- Godin Leisure-Time Exercise Questionnaire (GLTEQ)(Baseline and month 12 after patient inclusion)
- Physical Activity, Exercise, and Sport Questionnaire (Bewegungs- und Sportaktivität Fragebogen (BSA-F))(Baseline and month 12 after patient inclusion)
- Health Economic Evaluation(Baseline, month 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion)