Multiple SclerosisPExMSNCT04236544
Patient Experiences of Multiple Sclerosis (PExMS)
A study testing PExMS and DECIMS-Wiki and DECIMS-Wiki in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Universitätsklinikum Hamburg-Eppendorf.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Patient Engagement
- What is being tested?
- PExMS and DECIMS-Wiki and DECIMS-Wiki
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persons with relapsing-remitting multiple sclerosis
- being ≥18 years old
- considering starting, switching or stopping any immunotherapy
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Patient Engagement, Self Efficacy
- Being tested
- PExMS and DECIMS-Wiki, DECIMS-Wiki
- Keywords
- multiple sclerosis, decision making, decision support, web-based experiential information, patient experiences, narrative information
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PExMS and DECIMS-WikiBehavioural
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.
DECIMS-WikiBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PExMS and DECIMS-Wiki | Experimental | 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. Receives: Behavioral: PExMS and DECIMS-Wiki |
| DECIMS-Wiki | Active comparator | 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. Receives: Behavioral: DECIMS-Wiki |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing the feasibility of an intervention using patients' experiences as a supplement to evidence-based information in a pilot randomized controlled trial
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.
Measured: Baseline and up to 6 months after beginning, changing or stopping of the immunotherapy
Secondary outcomes (7)
Preparation for Decision Making
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.
Measured: Up to 14 days after usage of intervention or comparator website(s)
Decisional Conflict
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.
Measured: Baseline and up to 14 days after usage of intervention or comparator website(s)
Self-reported impact of eHealth on its users
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.
Measured: eHIQ-Part-1 at baseline and the eHIQ-Part-2 up to 14 days after usage of intervention or comparator website(s)
Affective forecasting in regard to immunotherapies
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.
Measured: Baseline and up to 14 days after usage of intervention or comparator website(s) and and 6 months after the beginning of the immunotherapy
Self-confidence in decision-making
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'.
Measured: Baseline and up to 14 days after usage of intervention or comparator website(s)
Patients' beliefs about the necessity of their medication and their concerns about the current medication
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.
Measured: Baseline and up to 14 days after usage of intervention or comparator website(s)
Adherence
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.
Measured: 6 months after beginning, changing or stopping of the immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Marianne-Strauss-Klinik, Berg, Germany, Gesundheitszentrum St. Johannes Hospital, Bonn, Germany, University Hospital of Cologne, Rechts der Isar Hospital, Munich, Germany, University Hospital Schleswig-Holstein
- Responsible party
- Sponsor
- Investigators
- Christoph Heesen, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236544
- Sponsor's protocol ID
- PExMS
- Acronym
- PExMS
- Status last verified
- Jan 2023
- First submitted
- 6 Dec 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Browne P, Chandraratna D, Angood C, Tremlett H, Baker C, Taylor BV, Thompson AJ. Atlas of Multiple Sclerosis 2013: A growing global problem with widespread inequity. Neurology. 2014 Sep 9;83(11):1022-4. doi: 10.1212/WNL.0000000000000768. No abstract available.
PubMed 25200713WHO. Atlas multiple sclerosis resources in the world 2008. Geneva; London: World Health Organization; Multiple Sclerosis International Federation; 2008. 51 p.
Heesen C, Kasper J, Segal J, Kopke S, Muhlhauser I. Decisional role preferences, risk knowledge and information interests in patients with multiple sclerosis. Mult Scler. 2004 Dec;10(6):643-50. doi: 10.1191/1352458504ms1112oa.
PubMed 15584489Heesen C, Schaffler N, Kasper J, Muhlhauser I, Kopke S. Suspected multiple sclerosis - what to do? Evaluation of a patient information leaflet. Mult Scler. 2009 Sep;15(9):1103-12. doi: 10.1177/1352458509106508. Epub 2009 Jul 22.
PubMed 19625332Heesen C, Kolbeck J, Gold SM, Schulz H, Schulz KH. Delivering the diagnosis of MS--results of a survey among patients and neurologists. Acta Neurol Scand. 2003 May;107(5):363-8. doi: 10.1034/j.1600-0404.2003.00086.x.
PubMed 12713529Rahn AC, Kopke S, Kasper J, Vettorazzi E, Muhlhauser I, Heesen C. Evaluator-blinded trial evaluating nurse-led immunotherapy DEcision Coaching In persons with relapsing-remitting Multiple Sclerosis (DECIMS) and accompanying process evaluation: study protocol for a cluster randomised controlled trial. Trials. 2015 Mar 21;16:106. doi: 10.1186/s13063-015-0611-7.
PubMed 25872529Newhouse N, Martin A, Jawad S, Yu LM, Davoudianfar M, Locock L, Ziebland S, Powell J. Randomised feasibility study of a novel experience-based internet intervention to support self-management in chronic asthma. BMJ Open. 2016 Dec 28;6(12):e013401. doi: 10.1136/bmjopen-2016-013401.
PubMed 28031210Ziebland S, Powell J, Briggs P, Jenkinson C, Wyke S, Sillence E, Harris P, Perera R, Mazanderani F, Martin A, Locock L, Kelly L, Booth M, Gann B, Newhouse N, Farmer A. Examining the role of patients' experiences as a resource for choice and decision-making in health care: a creative, interdisciplinary mixed-method study in digital health. Southampton (UK): NIHR Journals Library; 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK401199/
PubMed 27929620Powell J, Newhouse N, Martin A, Jawad S, Yu LM, Davoudianfar M, Locock L, Ziebland S. A novel experience-based internet intervention for smoking cessation: feasibility randomised controlled trial. BMC Public Health. 2016 Nov 11;16(1):1156. doi: 10.1186/s12889-016-3821-3.
PubMed 27835953Dillard AJ, Fagerlin A, Dal Cin S, Zikmund-Fisher BJ, Ubel PA. Narratives that address affective forecasting errors reduce perceived barriers to colorectal cancer screening. Soc Sci Med. 2010 Jul;71(1):45-52. doi: 10.1016/j.socscimed.2010.02.038. Epub 2010 Mar 21.
PubMed 20417005Bekker HL, Winterbottom AE, Butow P, Dillard AJ, Feldman-Stewart D, Fowler FJ, Jibaja-Weiss ML, Shaffer VA, Volk RJ. Do personal stories make patient decision aids more effective? A critical review of theory and evidence. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S9. doi: 10.1186/1472-6947-13-S2-S9. Epub 2013 Nov 29.
PubMed 24625283Engler J, Adami S, Adam Y, Keller B, Repke T, Fugemann H, Lucius-Hoene G, Muller-Nordhorn J, Holmberg C. Using others' experiences. Cancer patients' expectations and navigation of a website providing narratives on prostate, breast and colorectal cancer. Patient Educ Couns. 2016 Aug;99(8):1325-32. doi: 10.1016/j.pec.2016.03.015. Epub 2016 Mar 17.
PubMed 27067064Entwistle VA, France EF, Wyke S, Jepson R, Hunt K, Ziebland S, Thompson A. How information about other people's personal experiences can help with healthcare decision-making: a qualitative study. Patient Educ Couns. 2011 Dec;85(3):e291-8. doi: 10.1016/j.pec.2011.05.014. Epub 2011 Jun 8.
PubMed 21652162Giesler JM, Keller B, Repke T, Leonhart R, Weis J, Muckelbauer R, Rieckmann N, Muller-Nordhorn J, Lucius-Hoene G, Holmberg C. Effect of a Website That Presents Patients' Experiences on Self-Efficacy and Patient Competence of Colorectal Cancer Patients: Web-Based Randomized Controlled Trial. J Med Internet Res. 2017 Oct 13;19(10):e334. doi: 10.2196/jmir.7639.
PubMed 29030329Shaffer VA, Zikmund-Fisher BJ. All stories are not alike: a purpose-, content-, and valence-based taxonomy of patient narratives in decision aids. Med Decis Making. 2013 Jan;33(1):4-13. doi: 10.1177/0272989X12463266. Epub 2012 Oct 11.
PubMed 23065418
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04236544
- Acronym / sponsor ID
- PExMS / PExMS
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Marianne-Strauss-Klinik, Berg, Germany, Gesundheitszentrum St. Johannes Hospital, Bonn, Germany, University Hospital of Cologne, Rechts der Isar Hospital, Munich, Germany, University Hospital Schleswig-Holstein
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PExMS and DECIMS-Wiki | Experimental | Behavioral: PExMS and DECIMS-WikiAfter 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 | Active comparator | Behavioral: DECIMS-WikiAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- persons with relapsing-remitting multiple sclerosis
- being ≥18 years old
- considering starting, switching or stopping any immunotherapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PExMS and DECIMS-WikiThe 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. | Behavioural | PExMS and DECIMS-Wiki |
| DECIMS-WikiThe 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. | Behavioural | DECIMS-Wiki |
Primary outcome
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.
7 secondary outcomes
Preparation for Decision Making
Time frame: Up to 14 days after usage of intervention or comparator website(s)
Decisional Conflict
Time frame: Baseline and up to 14 days after usage of intervention or comparator website(s)
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)
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
Self-confidence in decision-making
Time frame: Baseline and up to 14 days after usage of intervention or comparator website(s)
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)
Adherence
Time frame: 6 months after beginning, changing or stopping of the immunotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 25200713Browne P, Chandraratna D, Angood C, Tremlett H, Baker C, Taylor BV, Thompson AJ. Atlas of Multiple Sclerosis 2013: A growing global problem with widespread inequity. Neurology. 2014 Sep 9;83(11):1022-4. doi: 10.1212/WNL.0000000000000768. No abstract available.
- BackgroundWHO. Atlas multiple sclerosis resources in the world 2008. Geneva; London: World Health Organization; Multiple Sclerosis International Federation; 2008. 51 p.
- Background: PubMed 15584489Heesen C, Kasper J, Segal J, Kopke S, Muhlhauser I. Decisional role preferences, risk knowledge and information interests in patients with multiple sclerosis. Mult Scler. 2004 Dec;10(6):643-50. doi: 10.1191/1352458504ms1112oa.
- Background: PubMed 19625332Heesen C, Schaffler N, Kasper J, Muhlhauser I, Kopke S. Suspected multiple sclerosis - what to do? Evaluation of a patient information leaflet. Mult Scler. 2009 Sep;15(9):1103-12. doi: 10.1177/1352458509106508. Epub 2009 Jul 22.
- Background: PubMed 12713529Heesen C, Kolbeck J, Gold SM, Schulz H, Schulz KH. Delivering the diagnosis of MS--results of a survey among patients and neurologists. Acta Neurol Scand. 2003 May;107(5):363-8. doi: 10.1034/j.1600-0404.2003.00086.x.
- Background: PubMed 25872529Rahn AC, Kopke S, Kasper J, Vettorazzi E, Muhlhauser I, Heesen C. Evaluator-blinded trial evaluating nurse-led immunotherapy DEcision Coaching In persons with relapsing-remitting Multiple Sclerosis (DECIMS) and accompanying process evaluation: study protocol for a cluster randomised controlled trial. Trials. 2015 Mar 21;16:106. doi: 10.1186/s13063-015-0611-7.
- Background: PubMed 28031210Newhouse N, Martin A, Jawad S, Yu LM, Davoudianfar M, Locock L, Ziebland S, Powell J. Randomised feasibility study of a novel experience-based internet intervention to support self-management in chronic asthma. BMJ Open. 2016 Dec 28;6(12):e013401. doi: 10.1136/bmjopen-2016-013401.
- Background: PubMed 27929620Ziebland S, Powell J, Briggs P, Jenkinson C, Wyke S, Sillence E, Harris P, Perera R, Mazanderani F, Martin A, Locock L, Kelly L, Booth M, Gann B, Newhouse N, Farmer A. Examining the role of patients' experiences as a resource for choice and decision-making in health care: a creative, interdisciplinary mixed-method study in digital health. Southampton (UK): NIHR Journals Library; 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK401199/
- Background: PubMed 27835953Powell J, Newhouse N, Martin A, Jawad S, Yu LM, Davoudianfar M, Locock L, Ziebland S. A novel experience-based internet intervention for smoking cessation: feasibility randomised controlled trial. BMC Public Health. 2016 Nov 11;16(1):1156. doi: 10.1186/s12889-016-3821-3.
- Background: PubMed 20417005Dillard AJ, Fagerlin A, Dal Cin S, Zikmund-Fisher BJ, Ubel PA. Narratives that address affective forecasting errors reduce perceived barriers to colorectal cancer screening. Soc Sci Med. 2010 Jul;71(1):45-52. doi: 10.1016/j.socscimed.2010.02.038. Epub 2010 Mar 21.
- Background: PubMed 24625283Bekker HL, Winterbottom AE, Butow P, Dillard AJ, Feldman-Stewart D, Fowler FJ, Jibaja-Weiss ML, Shaffer VA, Volk RJ. Do personal stories make patient decision aids more effective? A critical review of theory and evidence. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S9. doi: 10.1186/1472-6947-13-S2-S9. Epub 2013 Nov 29.
- Background: PubMed 27067064Engler J, Adami S, Adam Y, Keller B, Repke T, Fugemann H, Lucius-Hoene G, Muller-Nordhorn J, Holmberg C. Using others' experiences. Cancer patients' expectations and navigation of a website providing narratives on prostate, breast and colorectal cancer. Patient Educ Couns. 2016 Aug;99(8):1325-32. doi: 10.1016/j.pec.2016.03.015. Epub 2016 Mar 17.
- O'Connor A. User Manual - Decision Self-Efficacy Scale 1995Link provided by the sponsor.
- O'Connor AM. User Manual Stage of Decision Making 2003Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Heesen, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
Questions about this trial
What is this clinical trial studying?
A study testing PExMS and DECIMS-Wiki and DECIMS-Wiki in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Heesen, Prof. Dr. (+49 (0) 40 7410 53776, heesen@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236544, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.