Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
55 participants
INTERVENTIONAL
2024-01-01
2025-12-31
Brief Summary
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Detailed Description
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The investigators aim to evaluate whether PEx may help people with multiple sclerosis in their immunotherapy decision-making processes.
This project will follow the Medical Research Council framework for development and evaluation of complex interventions. After the development of a website with PEx, a randomised controlled pilot trial will be conducted in five neurological practices/clinics including 55 people with relapsing-remitting multiple sclerosis and accompanied by a process evaluation.
Participants will be randomly assigned either to i) an intervention group with a two weeks access to an evidence-based patient information resource and the PExMS-website as an adjunct or to ii) the control group with access to evidence information alone.
A 6-members advisory panel involving representatives of people with multiple sclerosis, researchers, and neurologists, who accompany the whole project will mentor this pilot RCT. The ethical committee of the Hamburg Chamber of Physicians approved the study protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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PExMS and DECIMS-Wiki
After allocation, the intervention group will receive access via a data-protected study platform (www.erecover.de) to PExMS and DECIMS-Wiki for a two-week period. The former is a multimedia website providing experiential information. DECIMS (Decision coaching in MS)-Wiki (www.wiki2.kkn-ms.de) is an evidence-based patient information website focusing multiple sclerosis immunotherapies. Afterwards, primary and secondary outcome measures will be obtained. In a next step, patient will be asked for their treatment decision in a physician encounter.
PExMS and DECIMS-Wiki
The intervention consists of an information provision on immunotherapies as a combination of factual and experiential information. PExMS is a multimedia website providing patient experiences with MS in everyday life and with therapies illustrated by video, audio and text files of 48 persons with multiple sclerosis. The development of the intervention followed largely recommendation for standardised qualitative research provided by international DIPEx (Database of Individual Patients' Experience of illness) association, which use standardised qualitative research methods to provide 'balanced' information from original interview data. Data for the website was generated in a qualitative interview study with relapsing remitting multiple sclerosis patients across Germany. DECIMS (Decision coaching in MS)-Wiki (www.wiki2.kkn-ms.de) is an evidence-based patient information website focusing multiple sclerosis immunotherapies.
DECIMS-Wiki
After allocation, the control group will receive access to the DECIMS-Wiki for a two-week period. DECIMS (Decision coaching in MS)-Wiki (www.wiki2.kkn-ms.de) is an evidence-based patient information website focusing multiple sclerosis immunotherapies. Afterwards, primary and secondary outcome measures will be obtained. In a next step, patient will be asked for their treatment decision in a physician encounter.
DECIMS-Wiki
The active comparator is DECIMS-Wiki, which is an evidence-based online information platform. It is considered to be excellent factual information about immunotherapies for multiple sclerosis.
Interventions
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PExMS and DECIMS-Wiki
The intervention consists of an information provision on immunotherapies as a combination of factual and experiential information. PExMS is a multimedia website providing patient experiences with MS in everyday life and with therapies illustrated by video, audio and text files of 48 persons with multiple sclerosis. The development of the intervention followed largely recommendation for standardised qualitative research provided by international DIPEx (Database of Individual Patients' Experience of illness) association, which use standardised qualitative research methods to provide 'balanced' information from original interview data. Data for the website was generated in a qualitative interview study with relapsing remitting multiple sclerosis patients across Germany. DECIMS (Decision coaching in MS)-Wiki (www.wiki2.kkn-ms.de) is an evidence-based patient information website focusing multiple sclerosis immunotherapies.
DECIMS-Wiki
The active comparator is DECIMS-Wiki, which is an evidence-based online information platform. It is considered to be excellent factual information about immunotherapies for multiple sclerosis.
Eligibility Criteria
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Inclusion Criteria
* being ≥18 years old
* considering starting, switching or stopping any immunotherapy
Exclusion Criteria
* persons with major cognitive deficits
* persons having poor German language skills
* persons who participated in the development phase of the PExMS-website, which took place prior to the pilot randomised controlled trial
18 Years
ALL
No
Sponsors
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Marianne-Strauss-Klinik, Berg, Germany
UNKNOWN
Gesundheitszentrum St. Johannes Hospital, Bonn, Germany
UNKNOWN
University Hospital Cologne, Cologne, Germany
UNKNOWN
Rechts der Isar Hospital, Munich, Germany
UNKNOWN
University Medical Center Schleswig-Holstein, Kiel, Germany
UNKNOWN
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Christoph Heesen, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Central Contacts
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References
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Related Links
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O'Connor A. User Manual - Decision Self-Efficacy Scale 1995
O'Connor AM. User Manual Stage of Decision Making 2003
Other Identifiers
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PExMS
Identifier Type: -
Identifier Source: org_study_id
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