Interactive Web Platform for EmPOWERment in Early Multiple Sclerosis
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
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- EBBC programme
Compared with
- Control group programme
What it measured
Main measures
Occurrence of new lesions on T2-weighted images on MRI scans
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
MRI lesionsTime to a second relapse
Change in relapse status from baseline (no endpoint), to month 1, 3, 6, 12, 18 (follow-up), and 24 (follow-up) after patient inclusion
Relapses
Other measures (18)
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
Quality of life (reported by participants)Immunotherapy Status Questionnaire
Baseline (no endpoint), month 1, 3, 6, 12, 18 (follow-up), 24 (follow-up) after patient inclusion
Patient Activation Measure (PAM)
Baseline and month 12 after patient inclusion
Coping self-efficacy (CSE) scale
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
Physical functionImpairment in the Expanded Disability Status Scale (EDSS)
Baseline and month 12 after patient inclusion
Disability progression
Who could take part
Early (CIS/RIS) · 18 to 65
Show the full criteria
Inclusion criteria
* 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
Exclusion criteria
* 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Digital lifestyle management application (levidex) for empowerment and health behaviour change in early multiple sclerosis - Results of the randomised controlled POWER@MS1 trial.Mult Scler · 2025
Results
Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1).BMJ Open · 2021
Results
Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)-study protocol for a randomised controlled trial.Trials · 2021
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History
Started
Jul 2019
Main results due
Apr 2023
Finished
Apr 2023