Interactive Web Platform for EmPOWERment in Early Multiple Sclerosis (POWER@MS1)

  • STATUS
    Not Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    216
  • sponsor
    Universitätsklinikum Hamburg-Eppendorf
Updated on 23 May 2022
fatigue
MRI
disease or disorder
clinically isolated syndrome
oligoclonal bands

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.

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 16 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.

Details
Condition Multiple Sclerosis
Treatment Levidex, Dexilev, EBBC programme, Control group programme
Clinical Study IdentifierNCT03968172
SponsorUniversitätsklinikum Hamburg-Eppendorf
Last Modified on23 May 2022

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