Clinical trial NCT04236544: Patient Experiences of Multiple Sclerosis (PExMS)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Patient Engagement
Self Efficacy
Keywords: multiple sclerosis
decision making
decision support
web-based experiential information
patient experiences
narrative information
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Marianne-Strauss-Klinik, Berg, Germany
name: Gesundheitszentrum St. Johannes Hospital, Bonn, Germany
name: University Hospital Cologne, Cologne, Germany
name: Rechts der Isar Hospital, Munich, Germany
name: University Medical Center Schleswig-Holstein, Kiel, Germany
First posted: 2020-01-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After informed consent, baseline data will be obtained by the staff member responsible for enrolment and people with multiple sclerosis will be randomly allocated in blocks with variable block length at a 1:1 ratio to the intervention or the control group. The allocation sequence will be computer-generated by a statistician not involved in the conduction of the trial.
Primary purpose: SUPPORTIVE_CARE

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Testing the feasibility of an intervention using patients' experiences as a supplement to evidence-based information in a pilot randomized controlled trial
timeFrame: Baseline and up to 6 months after beginning, changing or stopping of the immunotherapy
Secondary outcomes:
measure: Preparation for Decision Making
timeFrame: Up to 14 days after usage of intervention or comparator website(s)
measure: Decisional Conflict
timeFrame: Baseline and up to 14 days after usage of intervention or comparator website(s)
measure: Self-reported impact of eHealth on its users
timeFrame: eHIQ-Part-1 at baseline and the eHIQ-Part-2 up to 14 days after usage of intervention or comparator website(s)
measure: Affective forecasting in regard to immunotherapies
timeFrame: Baseline and up to 14 days after usage of intervention or comparator website(s) and and 6 months after the beginning of the immunotherapy
measure: Self-confidence in decision-making
timeFrame: Baseline and up to 14 days after usage of intervention or comparator website(s)
measure: Patients' beliefs about the necessity of their medication and their concerns about the current medication
timeFrame: Baseline and up to 14 days after usage of intervention or comparator website(s)
measure: Adherence
timeFrame: 6 months after beginning, changing or stopping of the immunotherapy
Other outcomes:
measure: Symptoms of Anxiety and Depression
timeFrame: Baseline and up to 14 days after usage of intervention or comparator website(s)
measure: Patient-reported disability
timeFrame: Baseline
measure: Stage of Decision Making
timeFrame: Baseline
measure: Control Preferences for involvement in treatment decisions
timeFrame: Baseline and up to 14 days after usage of intervention or comparator website(s)
Locations:
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Christoph Heesen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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