Development and Evaluation of a Web-based Programme on Relapse Management for People With Multiple Sclerosis

Summary

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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

BEHAVIORAL

web-based intervention programme

The intervention will be designed as an individualized, dialogue-based system that will provide PwMS coordinated, individually tailored information based on the software platform broca®. The intervention programme will consist of three sections: 1. EBPI/decision aid (five modules plus decision aid in case of an acute relapse) provided by the broca® programme. The key element of the EBPI/decision aid is the information on glucocorticosteroids for the treatment of acute relapses. 2. A webinar led via WebEx by a trained MS nurse with questioning/chat session (approx. 60-75min). 3. A supervised chat room provided via the DMSG (https://www.dmsg.de/ms-connect). In addition, email reminders will be used to enhance involvement of participants.

BEHAVIORAL

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

Participants in the control group will have access to web-based information material offered via the same platform (broca®) in addition to usual care. The control group intervention will be based on material of the German Multiple Sclerosis Society (DMSG) on relapse management. The programme will accompany the participants over a period of 4 weeks and a reminder system with neutral e-mail reminders will be used to promote the use of the programme.

Sponsors & Collaborators

• University of Cologne

  collaborator OTHER

• University Medical Center Goettingen

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• Gaia AG

  collaborator INDUSTRY

• Deutsche Multiple Sklerose Gesellschaft (DMSG), Bundesverband e.V.

  collaborator UNKNOWN

• MS-Stiftung Trier

  collaborator UNKNOWN

• BBK Dachverband e.V.

  collaborator UNKNOWN

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• Sascha Köpke, Prof. · Institute of Nursing Science, University of Cologne

• Anne C Rahn, Prof. · Institute of Social Medicine and Epidemiology, Nursing Research Unit, University of Lübeck

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-17

Primary Completion

2023-04-30

Completion

2023-05-05

Countries

• Germany

Study Locations