Patient Experiences of Multiple Sclerosis (PExMS) (PExMS)
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|ClinicalTrials.gov Identifier: NCT04236544|
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : February 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Patient Engagement Self Efficacy||Behavioral: PExMS and DECIMS-Wiki Behavioral: DECIMS-Wiki||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|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.|
|Primary Purpose:||Supportive Care|
|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|
|Estimated Study Start Date :||January 1, 2024|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: 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.
Behavioral: PExMS and DECIMS-Wiki
The intervention consists of an information provision on immunotherapies as a combination of factual and experiential information. PExMS is a multimedia website providing patient experiences with MS in everyday life and with therapies illustrated by video, audio and text files of 48 persons with multiple sclerosis. The development of the intervention followed largely recommendation for standardised qualitative research provided by international DIPEx (Database of Individual Patients' Experience of illness) association, which use standardised qualitative research methods to provide 'balanced' information from original interview data. Data for the website was generated in a qualitative interview study with relapsing remitting multiple sclerosis patients across Germany. DECIMS (Decision coaching in MS)-Wiki (www.wiki2.kkn-ms.de) is an evidence-based patient information website focusing multiple sclerosis immunotherapies.
Active Comparator: 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.
The active comparator is DECIMS-Wiki, which is an evidence-based online information platform. It is considered to be excellent factual information about immunotherapies for multiple sclerosis.
- 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.
- Preparation for Decision Making [ Time Frame: 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.
- Decisional Conflict [ Time Frame: 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 [ Time Frame: 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.
- Affective forecasting in regard to immunotherapies [ Time Frame: 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.
- Self-confidence in decision-making [ Time Frame: 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'.
- Patients' beliefs about the necessity of their medication and their concerns about the current medication [ Time Frame: 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.
- Adherence [ Time Frame: 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.
- Symptoms of Anxiety and Depression [ Time Frame: Baseline and up to 14 days after usage of intervention or comparator website(s) ]As a control parameter, the Hospital Anxiety and Depression Scale (HADS) will be administered. Seven of the items relate to anxiety and seven relate to depression. Each item on the HADS is scored from 0-3 and this means that a person with multiple sclerosis can score between 0 and 21 for either anxiety or depression. A score of 0-7 means 'Normal', 8-10 means 'Borderline abnormal' and 11-21 means 'Abnormal'.
- Patient-reported disability [ Time Frame: Baseline ]The Patient Determined Disease Steps (PDDS) measures patient-reported disability of persons with multiple sclerosis. The PDDS has nine ordinal levels ranging between 0 (normal) and 8 (bedridden).
- Stage of Decision Making [ Time Frame: Baseline ]The 'Stage of Decision Making' questionnaire asks for the patient's readiness to engage in decision-making, progress in decision-making and susceptibility to considering or re-considering options. It may be useful in screening out persons with multiple sclerosis who may not benefit from decision aids interventions.
- Control Preferences for involvement in treatment decisions [ Time Frame: Baseline and up to 14 days after usage of intervention or comparator website(s) ]The 5-item Control Preferences Scale (CPS) assess patients' preferences for involvement in treatment decisions. It consists of five ''cards'' on a board, each illustrating a different role in decision-making by means of a cartoon and short descriptive statement. The examiner asks the respondent to choose the preferred card, which is then covered up and cannot be chosen again. Afterwards, the examiner asks the respondent to choose the preferred card from the remaining four cards. The procedure continues until one card is left. If the second preference is incongruent with the first, the test is immediately re-administered. Six scores are possible based on the subject's two most preferred roles: active-active, active-collaborative, collaborative-active, collaborative-passive, passive-collaborative and passive-passive.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236544
|Contact: Christoph Heesen, Prof. Dr.||+49 (0) 40 7410 firstname.lastname@example.org|
|Contact: Anna Sippel, Dr.||+49 (0) 40 7410 email@example.com|
|Principal Investigator:||Christoph Heesen, Prof. Dr.||Universitätsklinikum Hamburg-Eppendorf|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Universitätsklinikum Hamburg-Eppendorf|
|Other Study ID Numbers:||
|First Posted:||January 22, 2020 Key Record Dates|
|Last Update Posted:||February 8, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||The study centre will coordinate the intra-study data sharing process publishing anonymized data set in major journals. The results of our study will be presented at national and international conferences and published in peer-reviewed journals.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||The IPD will become available when summary data are published.|
|Access Criteria:||IPD will be shared upon request from the principal investigator.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
web-based experiential information
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases