Development and Evaluation of a Web-based Programme on Relapse Managem

Development and Evaluation of an Interactive Web-based Programme on Relapse Management for People With Multiple Sclerosis - a Randomized Controlled Trial With Mixed Methods Process Evaluation

CompletedNot a drug-phase studyRelapsing MSNCT04233970

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • web-based intervention programme

Compared with

  • web-based information material offered via the same platform (broca®) in addition to usual care

What it measured

Main measures

  • Assessment of change in relapse treatment (relapses not treated or treated with oral steroids).

    Telephone interview at month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 after patient inclusion and after final patient reaches month 12

    Relapses

Other measures (11)

  • Annual relapse rate

    Telephone interview at month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 after patient inclusion and after final patient reaches month 12

    Relapses

  • Relapse Risk Knowledge

    Month 3 and 12 after patient inclusion

    Relapses

  • Planned Behaviour in MS Scale (PBMS relapse)

    Month 3 and 12 after patient inclusion

    Relapses

  • Control Preference Scale relapse (CPS relapse)

    Month 3 after patient inclusion

    Relapses

  • Patient Activation Measure (PAM)

    Baseline, month 3, 12, 24, 30, 36 after patient inclusion and after final patient reaches month 12

  • Impairment in the Expanded Disability Status Scale (EDSS)

    Baseline and month 12 after patient inclusion

    Disability progression

  • United Kingdom Neurological Disability Scale (UNDS)

    Telephone interview at Baseline, month 12, 15, 18, 21, 24, 27, 30, 33, 36 after patient inclusion and after the final patient reaches month 12

    VisionThinking and memoryFatigueBladder, bowel and sexual functionPainMood and sleep

  • Hamburg Quality of life in MS Scale (HAQUAMS)

    Baseline and month 12 after patient inclusion

    Quality of life (reported by participants)

  • EQ-5D

    Baseline, month 3, 12, 24, 30, 36 after patient inclusion and after the final patient reaches month 12

    Quality of life (reported by participants)

  • Hospital Anxiety and Depression Scale (HADS)

    Baseline and month 12 after patient inclusion

    Mood and sleep

Who could take part

Relapsing MS · 18 to 65

Show the full criteria

Inclusion criteria

* signed informed consent * clinically isolated syndrom, suspected or diagnosed relapsing remitting MS * at least 1 relapse in the last year and/or at least 2 relapses in the last 2 years * access to the internet and ability to use websites

Exclusion criteria

* primary progressive MS * secondary progressive MS * acute relapse * severe visual impairment * severe psychiatric disorder (judged based on clinical impression) * allergic hypersensitivity to corticosteroids * participation in the EBSIMS training programme (the relapse management training programme was offered in Hamburg and Bad Segeberg)

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 will evaluate a web-based relapse management programme, which is easily accessible for people with multiple sclerosis. The trial is accompanied by a mixed-methods process evaluation and a health economic evaluation. It is expected that the programme will positively change patients' relapse management and strengthen their autonomy and participation.

Papers

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History

    1. Started

      Feb 2020

    2. Main results due

      Apr 2023

    3. Finished

      May 2023

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