Interactive Web Platform for EmPOWERment in Early Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

      The secondary objectives are to determine if the web-based intervention can

        -  strengthen patient autonomy and empowerment,

        -  promote informed decisions on immunotherapy,

        -  improve quality of life,

        -  reduce anxiety and depression,

        -  increase physical activity and a healthy diet,

        -  increase effectiveness of neurologists encounters,

        -  and save health care costs.

      In order to develop and evaluate the intervention, a multiphase mixed-methods study covering
      the first three phases of the Medical Research Council Framework for complex interventions
      will be conducted. After development, the intervention programme will be pretested and
      piloted with experts and persons with MS (pwMS). The intervention will be evaluated in a
      randomized controlled trial (RCT) with 328 patients with early MS (< 12 months), who have at
      least two MS-typical lesions. Study participants will be recruited in 19 MS centres across
      Germany and randomised to an intervention group with access to an evidence-based information
      platform or to a control group with optimised standard care based on material of the German
      Multiple Sclerosis Society (DMSG). The primary endpoint will be reached if new T2 lesions or
      relapses occur. Furthermore, a mixed methods process evaluation and a health economic
      evaluation will be carried out.

      Recalculated sample size: Based on a blinded data export of August 16th, 2021, with data on
      event rates (primary endpoint: new T2 lesion or new relapse) of 135 included patients at that
      time, a blinded sample size recalculation was performed. The sample size recalculation
      resulted in a lower number of necessary cases due to high event rates (51 primary endpoint
      events at that time). The calculation of event rates and an assumed dropout rate of 20%
      resulted in a case number of 216 patients that have to be randomized (108 per group) instead
      of 328.
    

Intervention name(s): EBBC programme; Control group programme
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Web-based behavioural lifestyle intervention that provides patients with coordinated information based on their existing health beliefs, interests, etc. In the programme, techniques and exercises will be taught in sequentially active interactive learning units ("simulated dialogues") and followed-up with email and SMS reminders in the second study year. The following topics will be focused on:
Diagnosis and disease progression
Support in disease processing
Techniques for coping with stress and depressive symptoms as well as developing positive emotions
Optimisation of dietary behaviour
Optimisation of physical activity behaviour
Sleep hygiene and methods for dealing with insomnia.
The programme will accompany each patient with information material and e-mail reminders over a period of 12 months with initial 2-3 weekly tasks, later only weekly reminders and inputs every 2 weeks. All in all, the intervention programme will consist of 16 modules.; Web-based information platform with optimized standard care compiled from information material of the German Multiple Sclerosis Society (DMSG). Information will be provided in sequentially activated modules over a period of 12 months, covering the following topics:
Disease progression
Invisible symptoms of multiple sclerosis
Symptomatic therapy
Immunotherapy decision support
Coping strategies
Autonomy
Fatigue
Quality of life
Physical activity
Nutritional behaviour
In addition, a reminder system with neutral e-mail reminders will be used to promote the use of the programme.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Multiple Sclerosis; Complex Intervention; Lifestyle Intervention; Randomized Controlled Trial; Evidence-based Medicine