Patient Experiences of Multiple Sclerosis (PExMS)
- Conditions
- Patient EngagementMultiple SclerosisMultiple Sclerosis, Relapsing-RemittingSelf Efficacy
- Interventions
- Behavioral: PExMS and DECIMS-WikiBehavioral: DECIMS-Wiki
- Registration Number
- NCT04236544
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 55
- persons with relapsing-remitting multiple sclerosis
- being ≥18 years old
- considering starting, switching or stopping any immunotherapy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PExMS and DECIMS-Wiki 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. DECIMS-Wiki 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.
- Primary Outcome Measures
Name Time Method Testing the feasibility of an intervention using patients' experiences as a supplement to evidence-based information in a pilot randomized controlled trial 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 Outcome Measures
Name Time Method Preparation for Decision Making Up to 14 days after usage of intervention or comparator website(s) To assess how useful a decision support intervention is in preparing patients with multiple sclerosis to communicate at a consultation visit and making a decision concerning a therapy, the 10-item Preparation for Decision Making (PrepDM) scale will be used. It has a five-point-Likert scale format and is designed to be administered after the consultation visit to discuss treatment options. Higher scores show a higher perceived level of preparation for decision-making.
Self-confidence in decision-making Baseline and up to 14 days after usage of intervention or comparator website(s) The 11-item Decision Self-Efficacy Scale (DSES) measures self-confidence in decision-making on a five-point-Likert scale. It ranges between 0 (not at all confident) and 4 (very confident). For the total score, items are summed, divided by 11 and multiplied by 25. A total score of 0 means 'extremely low self-efficacy' and a score of 100 means 'extremely high self-efficacy'.
Decisional Conflict Baseline and up to 14 days after usage of intervention or comparator website(s) The 4-item yes/no response "Sure of myself, Understand information, Risk-benefit ratio, Encouragement" (SURE) screening test addresses decisional conflict in patients. This screening instrument was developed to help health professionals assess patients' perception of uncertainty about decision-making for a therapy. The SURE screening test has dichotomous questions, where "yes" equals 1 point and "no" equals 0 point. If the total score is less than 4, it indicates the probability that the patient experiences clinically significant decisional conflict.
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) The eHealth Impact Questionnaire (eHIQ) measures users' attitudes towards a website which they recently viewed. It is divided into the 11-item eHIQ-Part 1, asking for general attitudes towards using the internet to access health information and the 26-item eHIQ-Part 2, which is related to the effects of using a specific health-related website on three subscales: 1) confidence and identification, 2) information and presentation and 3) understanding and motivation. Both answering formats range from 1 (strongly disagree) to 5 (strongly agree). Moreover, identifying with others who show their experiences on a website, knowing that other pwMS are handling similar problems and learning how they manage difficult issues can reduce the feeling of isolation and improve the sense of social support. Reformulated items from the subscale "confidence and identification" of the eHIQ will be used to assess social support.
Adherence 6 months after beginning, changing or stopping of the immunotherapy Patients who belief in a strong necessity of their medication have higher adherence behavior. We hypothesize that patients' experiences about the aspects of an immunotherapy in everyday life may prepare other persons with MS for difficulties they might face and improve their resilience under this condition and the adherence to a given immunotherapy.
Participants have to answer adherence questions referred to the last four weeks for oral DMTs and self-injectables or the past six months for taking infusions.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) The 11-item subscale 'Specific Necessity Beliefs' of the 'Beliefs about Medicines Questionnaire' (BMQ) assesses specific concerns about the current medication. All items are scored on a 5-point Likert-scale, ranging from "0" (totally disagree) to "4" (totally agree). Scores obtained for individual items are summed. Higher scores indicate stronger beliefs.
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 As suitable instruments to assess affective forecasts regarding the use of immunotherapies were lacking, we developed the 'Affective Forecasting in Immunotherapy for Multiple Sclerosis questionnaire' (AForT-MS). It consists of items addressing anticipated positive and negative emotions, fears and hopes, regret, and focalism in regard to immunotherapies. Ratings have to be performed based on a 6-point Likert scale. Cognitive interviews with n=6 persons with MS were executed using the verbal probing method to identify potentially problematic questions, difficulties and ambiguities which could lead to unintended answers and to improve the questionnaire. The online version of the AFort-MS will be tested in a sample of persons with MS being in the decision-making process to start, change or stop an immunotherapy and revised afterwards. In a second step, we will administer the revised AForT-MS to the same sample of persons with MS in the pilot RCT to conduct an exploratory factor analysis.