CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
web-based intervention programme +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04233970
NCT04233970N/ACompleted
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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

Universitätsklinikum Hamburg-Eppendorf·interventional·Posted Jan 18, 2020·Updated Sep 13, 2023

In Brief

A clinical study evaluating web-based intervention programme and web-based information material offered via the same platform (broca®) in addition to usual care for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 160 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Relapsing-Remitting
CountriesGermany
CollaboratorsUniversity of Cologne, University Medical Center Goettingen, Heinrich-Heine University, Duesseldorf, Gaia AG, Deutsche Multiple Sklerose Gesellschaft (DMSG), Bundesverband e.V., MS-Stiftung Trier, BBK Dachverband e.V.

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 18, 2020
Enrollment StartFeb 17, 2020
Primary CompletionApr 30, 2023
Study CompletionMay 5, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.5 years ago

Interventions

web-based intervention programmebehavioral

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.

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

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.