Patient Experiences of Multiple Sclerosis (PExMS)

Universitätsklinikum Hamburg-Eppendorf

Status: Not yet enrolling

Conditions: Self Efficacy; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Patient Engagement

Treatments: Behavioral: DECIMS-Wiki; Behavioral: PExMS and DECIMS-Wiki

Study type: Interventional

Funder types: Other

Identifiers

NCT04236544

PExMS

Details and patient eligibility

About

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.

Full description

A variety of management options (e.g. 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 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• persons with relapsing-remitting multiple sclerosis
• being ≥18 years old
• considering starting, switching or stopping any immunotherapy

Exclusion criteria

• persons with secondary progressive multiple sclerosis or primary progressive multiple sclerosis
• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups

PExMS and DECIMS-Wiki

Experimental group

Description:

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.

Treatment:

Behavioral: PExMS and DECIMS-Wiki

DECIMS-Wiki

Active Comparator group

Description:

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.

Treatment:

Behavioral: DECIMS-Wiki