Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04236544
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-08
First Post:
2019-12-06
Brief Title:
Patient Experiences of Multiple Sclerosis PExMS
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Impact of a Multimedia Website With Patient Experiences of Multiple Sclerosis PExMS on Immunotherapy Decision-making a Pilot Randomised Controlled Trial in a Mixed-methods Design
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PExMS
Brief Summary:
Besides coping with the diagnosis people with multiple sclerosis have to make complex decisions such as deciding about immunotherapies They search not only for factual information but also for reports of patient experiences PEx The investigators aim to evaluate in a randomised controlled pilot trial whether a website presenting PEx as an adjunct to factual information may help people with multiple sclerosis in their immunotherapy decision-making processes
Detailed Description:
A variety of management options eg immunotherapies lifestyle interventions and rehabilitation are available for people with relapsing-remitting multiple sclerosis Besides coping with the diagnosis people with multiple sclerosis have to make complex decisions such as deciding about immunotherapies In addition to factual information reports of patient experiences PEx may support patients in decision-making The added value of PEx in decision-making is not clear and controlled studies are rare Therefore systematic methods are necessary in order to develop and analyse PEx As there are no evaluated PEx for multiple sclerosis in Germany the investigators are currently creating a website presenting PEx structured according to topics and illustrated by video audio and text files
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 practicesclinics 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
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 practicesclinics 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None