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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 主要终点
- Testing the feasibility of an intervention using patients' experiences as a supplement to evidence-based information in a pilot randomized controlled trial
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persons with relapsing-remitting multiple sclerosis
- •being ≥18 years old
- •considering starting, switching or stopping any immunotherapy
排除标准
- •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
结局指标
主要结局
Testing the feasibility of an intervention using patients' experiences as a supplement to evidence-based information in a pilot randomized controlled trial
时间窗: 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.
次要结局
- 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)