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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 55
- Primary Endpoint
- Testing the feasibility of an intervention using patients' experiences as a supplement to evidence-based information in a pilot randomized controlled trial
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
We will explain in our information and consent form that we intend to assess whether patients with mutiple sclerosis find different health information websites helpful on a range of self-reported outcomes. Researchers involved in study recruitment, administration of interventions and data analysis will be blind to the allocation of intervention and control group.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: PExMS and DECIMS-Wiki (Behavioral)
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.
Intervention: DECIMS-Wiki (Behavioral)
Outcomes
Primary Outcomes
Testing the feasibility of an intervention using patients' experiences as a supplement to evidence-based information in a pilot randomized controlled trial
Time Frame: Baseline and up to 6 months after beginning, changing or stopping of the immunotherapy
The specific measures to test the feasibility are: * Number of participants consented, recruited, randomized, withdrawn, and retained * Numbers of participants with completed outcome measures or lost to follow-up * Acceptability of the intervention in terms of site visits, frequency, and duration of usage as well as experience, barriers, and facilitators to use the intervention - from persons with MS and health professionals from participating study centers * Acceptability of the study procedures in terms of barriers and facilitators to implementation - from persons with MS and participating study centers.
Secondary Outcomes
- Preparation for Decision Making(Up to 14 days after usage of intervention or comparator website(s))
- Self-confidence in decision-making(Baseline and up to 14 days after usage of intervention or comparator website(s))
- Decisional Conflict(Baseline and up to 14 days after usage of intervention or comparator website(s))
- Self-reported impact of eHealth on its users(eHIQ-Part-1 at baseline and the eHIQ-Part-2 up to 14 days after usage of intervention or comparator website(s))
- Adherence(6 months after beginning, changing or stopping of the immunotherapy)
- Patients' beliefs about the necessity of their medication and their concerns about the current medication(Baseline and up to 14 days after usage of intervention or comparator website(s))
- Affective forecasting in regard to immunotherapies(Baseline and up to 14 days after usage of intervention or comparator website(s) and and 6 months after the beginning of the immunotherapy)