Interactive Web Platform for EmPOWERment in Early Multiple Sclerosis

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.

Conditions

• Multiple Sclerosis

Interventions

BEHAVIORAL

EBBC programme

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: 1. Diagnosis and disease progression 2. Support in disease processing 3. Techniques for coping with stress and depressive symptoms as well as developing positive emotions 4. Optimisation of dietary behaviour 5. Optimisation of physical activity behaviour 6. 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.

BEHAVIORAL

Control group programme

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: 1. Disease progression 2. Invisible symptoms of multiple sclerosis 3. Symptomatic therapy 4. Immunotherapy decision support 5. Coping strategies 6. Autonomy 7. Fatigue 8. Quality of life 9. Physical activity 10. Nutritional behaviour In addition, a reminder system with neutral e-mail reminders will be used to promote the use of the programme.

Sponsors & Collaborators

• Charite University, Berlin, Germany

  collaborator OTHER

• University of Cologne

  collaborator OTHER

• University Medical Center Goettingen

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• Gaia AG

  collaborator INDUSTRY

• BKK Dachverband e.V.

  collaborator UNKNOWN

• Deutsche Multiple Sklerose Gesellschaft (DMSG)

  collaborator UNKNOWN

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• Christoph Heesen, Prof. · Universitätsklinikum Hamburg-Eppendorf

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

2019-07-01

Primary Completion

2023-04-05

Completion

2023-04-05

Countries

• Germany

Study Locations