Multiple SclerosisPOWER@MS1NCT03968172
Interactive Web Platform for EmPOWERment in Early Multiple Sclerosis
A study testing EBBC programme in people with Multiple Sclerosis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This randomized controlled trial with an accompanying process evaluation investigates the hypothesis that behavioural and web-based information on immunotherapy decisions, disease management and lifestyle can change patient behaviour resulting in reduced inflammatory disease activity in multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- EBBC programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2019to 5 Apr 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent
- clinically isolated syndrome (CIS), suspected or confirmed MS for less than 12 months
- at least two MS-typical lesions on T2-weighted images on MRI scans
- MS typical cerebrospinal fluid (CSF) finding with detection of oligoclonal bands
- access to the internet and ability to use websites
Who cannot join
- corticosteroid therapy within 4 weeks prior to study inclusion
- substantial psychiatric disorder (based on clinical impression)
- severe cognitive deficit affecting information uptake (based on clinical impression)
- pregnancy
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of a Web-based Lifestyle Intervention for EmPOWERment in Early Multiple Sclerosis (POWER@MS1) - a Randomized Controlled Trial and Mixed-methods Process Evaluation
This randomized controlled trial with an accompanying process evaluation investigates the hypothesis that behavioural and web-based information on immunotherapy decisions, disease management and lifestyle can change patient behaviour resulting in reduced inflammatory disease activity in multiple sclerosis.
Read the detailed description
After a multiple sclerosis (MS) diagnosis, uncertainty and psychological stress may have a negative effect on the disease course, while psychological counselling may reduce inflammatory activity. Therefore, especially newly diagnosed patients require intensive and individual support to deal with the disease and to initiate lifestyle changes. This is hardly available in standard care. Systematic, evidence-based patient information on the value of lifestyle change is not available either.
POWER@MS1 aims to encourage patients with MS to find the best way of dealing with the disease on the basis of evidence-based patient information (EBPI) and a complex behaviour change intervention. The platform will serve as a disease accompanying empowerment programme. Various modules will be provided to accompany patients with MS (pwMS) at an early stage of the disease. The multicomponent intervention will offer comprehensive support after diagnosis, which includes, firstly, an immunotherapy decision-support programme aligned with principles of shared decision-making (SDM), and, secondly, a behaviour-change intervention promoting disease management and lifestyle habits over a period of one year. Ideally, POWER@MS1 leads to a more targeted immunotherapy start, and consequently to better adherence and optimization of a preventive effective lifestyle.
Primary objective:
To determine if a web-based behavioural intervention on immunotherapy decision making, disease management, and lifestyle can reduce the inflammatory disease activity in MS (a relapse or - as a surrogate for inflammatory disease activity - new T2 lesions on magnetic resonance imaging (MRI)).
Secondary objectives:
The secondary objectives are to determine if the web-based intervention can
- strengthen patient autonomy and empowerment,
- promote informed decisions on immunotherapy,
- improve quality of life,
- reduce anxiety and depression,
- increase physical activity and a healthy diet,
- increase effectiveness of neurologists encounters,
- and save health care costs.
In order to develop and evaluate the intervention, a multiphase mixed-methods study covering the first three phases of the Medical Research Council Framework for complex interventions will be conducted. After development, the intervention programme will be pretested and piloted with experts and persons with MS (pwMS). The intervention will be evaluated in a randomized controlled trial (RCT) with 328 patients with early MS (< 12 months), who have at least two MS-typical lesions. Study participants will be recruited in 19 MS centres across Germany and randomised to an intervention group with access to an evidence-based information platform or to a control group with optimised standard care based on material of the German Multiple Sclerosis Society (DMSG). The primary endpoint will be reached if new T2 lesions or relapses occur. Furthermore, a mixed methods process evaluation and a health economic evaluation will be carried out.
Recalculated sample size: Based on a blinded data export of August 16th, 2021, with data on event rates (primary endpoint: new T2 lesion or new relapse) of 135 included patients at that time, a blinded sample size recalculation was performed. The sample size recalculation resulted in a lower number of necessary cases due to high event rates (51 primary endpoint events at that time). The calculation of event rates and an assumed dropout rate of 20% resulted in a case number of 216 patients that have to be randomized (108 per group) instead of 328.
- Conditions
- Multiple Sclerosis
- Being tested
- EBBC programme, Control group programme
- Keywords
- Multiple Sclerosis, Complex Intervention, Lifestyle Intervention, Randomized Controlled Trial, Evidence-based Medicine
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBBC programmeBehavioural
Web-based behavioural lifestyle intervention that provides patients with coordinated information based on their existing health beliefs, interests, etc. In the programme, techniques and exercises will be taught in sequentially active interactive learning units ("simulated dialogues") and followed-up with email and SMS reminders in the second study year. The following topics will be focused on:
- Diagnosis and disease progression
- Support in disease processing
- Techniques for coping with stress and depressive symptoms as well as developing positive emotions
- Optimisation of dietary behaviour
- Optimisation of physical activity behaviour
- Sleep hygiene and methods for dealing with insomnia.
The programme will accompany each patient with information material and e-mail reminders over a period of 12 months with initial 2-3 weekly tasks, later only weekly reminders and inputs every 2 weeks. All in all, the intervention programme will consist of 16 modules.
Control group programmeBehavioural
Web-based information platform with optimized standard care compiled from information material of the German Multiple Sclerosis Society (DMSG). Information will be provided in sequentially activated modules over a period of 12 months, covering the following topics:
- Disease progression
- Invisible symptoms of multiple sclerosis
- Symptomatic therapy
- Immunotherapy decision support
- Coping strategies
- Autonomy
- Fatigue
- Quality of life
- Physical activity
- Nutritional behaviour
In addition, a reminder system with neutral e-mail reminders will be used to promote the use of the programme.
| Study group | Role | What they receive |
|---|---|---|
| EBBC programme | Experimental | Participants in the intervention group will receive access to evidence-based patient information (EBPI) about lifestyle factors in MS combined with a complex behaviour change programme (EBBC programme), an online tool that was developed in line with principles of patient empowerment and cognitive behavioural therapy (CBT) approaches, including acceptance and mindfulness oriented techniques. Receives: Behavioral: EBBC programme |
| Control group programme | Active comparator | Participants randomized to the active control group will receive access to an information platform with optimized standard care consisting of information compiled from the German Multiple Sclerosis Society (DMSG) information material to reflect current practice. Receives: Behavioral: Control group programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of new lesions on T2-weighted images on MRI scans
As a surrogate for inflammatory disease activity, new T2 lesions will be assessed in MRI.
MRI protocol: Localizer, 3D FLAIR sagittal e.g. 3x3mmm, 3D image T1w native sagittal, 1-3mm, PD/T2w axial 3mm, protocol duration approx. 20 min.
Measured: Change in the number of lesions on T2-weighted images from immediately after patient inclusion (month 0), to month 3, 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion
Time to a second relapse
Duration of complaints/impairment, relapse symptoms (worsened or newly occurred), degree of impairment due to the relapse and degree of certainty with regard to the classification of the worsening as a relapse.
Measured: Change in relapse status from baseline (no endpoint), to month 1, 3, 6, 12, 18 (follow-up), and 24 (follow-up) after patient inclusion
Secondary outcomes (18)
Risk Knowledge (RiKno10)
To assess risk knowledge, RiKno 2.0 was adapted to a 10-item version (RiKno10).
Measured: Month 3 after patient inclusion
Control Preference Scale (CPS)
As a surrogate of decision quality, preferred and realized role preference based on the Control Preference Scale (CPS) will be assessed. The scores for preferred and realized roles are grouped into active, collaborative or passive.
Measured: Month 12 after patient inclusion, as well as after reaching the primary endpoint
Immunotherapy Decision Satisfaction Questionnaire
As a surrogate of decision quality, satisfaction with the immunotherapy decision will be assessed.
Measured: After reaching the primary endpoint
Immunotherapy Status Questionnaire
It will be assessed whether an immunotherapy was newly started, aborted or changed.
Measured: Baseline (no endpoint), month 1, 3, 6, 12, 18 (follow-up), 24 (follow-up) after patient inclusion
Patient Activation Measure (PAM)
Assessment of patient activation development (i.e. expressed in the confidence and knowledge to take action, as well as actually taking health-related action).
Measured: Baseline and month 12 after patient inclusion
Coping self-efficacy (CSE) scale
Based on the coping self-efficacy (CSE) scale, selected and adapted items will be used to measure perceived self-efficacy for emotion-focused coping behaviours. In this study, response options are ranging from 0 (completely disagree), representing a low coping self-efficacy value, to 3 (fully agree), representing a high coping self-efficacy value.
Measured: Baseline and month 12 after patient inclusion
Changes in Perceived Empowerment Questionnaire
Changes in perceived empowerment will be measured based on selected and adapted items of a 3-point scale empowerment questionnaire measuring changes in patients' feelings of empowerment and/or control over their health problem.
Measured: Month 12 after patient inclusion
Credibility/Expectancy Questionnaire
Selected items measuring treatment expectancy and credibility.
Measured: 4 weeks after patient inclusion (month 1)
Readiness to Change (stage assessment) based on the Health Action Process Approach (HAPA)
Readiness to change will be assessed based on the Health Action Process Approach (HAPA) in order to determine the interventions impact on willingness to change lifestyle activities, such as physical activity and nutritional behaviour.
Measured: Baseline, month 3 and 12 after patient inclusion
Impairment in the Expanded Disability Status Scale (EDSS)
MS impairment measurement with a score ranging from 0.0 (normal neurological exam) to 10.0 (death due to MS).
Measured: Baseline and month 12 after patient inclusion
Hamburg Quality of life in MS Scale (HAQUAMS)
Assessment of MS-specific quality of life based on 8 subscales (consisting of 38 individual items) and 4 additional questions. For all subscales, averaged subscores are calculated from the values of the respective items (ranging from 1 to 5), with high scores standing for low quality of life and low scores standing for high quality of life.
Measured: Baseline and month 12 after patient inclusion
EQ-5D
Assessment of health-related quality of life.
Measured: Baseline, month 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion
Hospital anxiety and distress scale (HADS)
Assessment of depression and anxiety based on 14 items on 2 scales (7 on the subscale "anxiety" and 7 on the subscale "depression"), ranging from 0 (low anxiety/depression level) to 3 (high anxiety/depression level) per item, resulting in a range of 0 to 21 per scale or 0 to 42 for the total HADS value.
Measured: Baseline and month 12 after patient inclusion
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Amount of mild, moderate and strenuous exercise in leisure time.
Measured: Baseline and month 12 after patient inclusion
Physical Activity, Exercise, and Sport Questionnaire (Bewegungs- und Sportaktivität Fragebogen (BSA-F))
Assessment of physical activity, including occupational activity, leisure time activity and sports.
Measured: Baseline and month 12 after patient inclusion
Questionnaire of Healthy Diet (QHOD2), adapted version of the Mediterranean Diet Screener (aMDS)
Frequency of intake of characteristic food groups (e.g. vegetables, fish, and olive oil) in the last seven days and is an indicator of the degree of adherence to an adapted Mediterranean dietary pattern.
Measured: Baseline, month 3 and 12 after patient inclusion
24-h dietary recall myfood24
Aggregated nutrient intake data (e.g. omega-3-fatty acids).
Measured: Baseline and month 12 after patient inclusion, in each case three times within two to three weeks (two weekdays and one weekend day)
Health Economic Evaluation
Assessment of all direct costs associated with the intervention as well as costs resulting from the consumption of health-related goods and services as well as indirect costs due to productivity losses.
Measured: Baseline, month 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Jul 2019
- Primary completion5 Apr 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Cologne, University Medical Center Goettingen, Heinrich-Heine University, Duesseldorf, Gaia AG, BKK Dachverband e.V., Deutsche Multiple Sklerose Gesellschaft (DMSG)
- Responsible party
- Sponsor
- Investigators
- Christoph Heesen, Prof., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968172
- Sponsor's protocol ID
- POWER@MS1
- Acronym
- POWER@MS1
- Status last verified
- Sep 2023
- First submitted
- 15 May 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymized individual data set will be published in major journals in order to disseminate the study results. In addition, all trial results will be communicated at scientific conferences and meetings by the investigators and presented on the DMSG website and other relevant patient websites.
Publications
Krause N, Riemann-Lorenz K, Steffen T, Rahn AC, Pottgen J, Stellmann JP, Kopke S, Friede T, Icks A, Vomhof M, Temmes H, van de Loo M, Gold SM, Heesen C. Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1). BMJ Open. 2021 Feb 16;11(2):e041720. doi: 10.1136/bmjopen-2020-041720.
PubMed 33593774
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Web-based Lifestyle Intervention for EmPOWERment in Early Multiple Sclerosis (POWER@MS1) - a Randomized Controlled Trial and Mixed-methods Process Evaluation
- ClinicalTrials.gov ID
- NCT03968172
- Acronym / sponsor ID
- POWER@MS1 / POWER@MS1
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Complex Intervention, Lifestyle Intervention, Randomized Controlled Trial, Evidence-based Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Cologne, University Medical Center Goettingen, Heinrich-Heine University, Duesseldorf, Gaia AG, BKK Dachverband e.V., Deutsche Multiple Sklerose Gesellschaft (DMSG)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 30 May 2019 (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.
This randomized controlled trial with an accompanying process evaluation investigates the hypothesis that behavioural and web-based information on immunotherapy decisions, disease management and lifestyle can change patient behaviour resulting in reduced inflammatory disease activity in multiple sclerosis.
Detailed description
After a multiple sclerosis (MS) diagnosis, uncertainty and psychological stress may have a negative effect on the disease course, while psychological counselling may reduce inflammatory activity. Therefore, especially newly diagnosed patients require intensive and individual support to deal with the disease and to initiate lifestyle changes. This is hardly available in standard care. Systematic, evidence-based patient information on the value of lifestyle change is not available either.
POWER@MS1 aims to encourage patients with MS to find the best way of dealing with the disease on the basis of evidence-based patient information (EBPI) and a complex behaviour change intervention. The platform will serve as a disease accompanying empowerment programme. Various modules will be provided to accompany patients with MS (pwMS) at an early stage of the disease. The multicomponent intervention will offer comprehensive support after diagnosis, which includes, firstly, an immunotherapy decision-support programme aligned with principles of shared decision-making (SDM), and, secondly, a behaviour-change intervention promoting disease management and lifestyle habits over a period of one year. Ideally, POWER@MS1 leads to a more targeted immunotherapy start, and consequently to better adherence and optimization of a preventive effective lifestyle.
Primary objective:
To determine if a web-based behavioural intervention on immunotherapy decision making, disease management, and lifestyle can reduce the inflammatory disease activity in MS (a relapse or - as a surrogate for inflammatory disease activity - new T2 lesions on magnetic resonance imaging (MRI)).
Secondary objectives:
The secondary objectives are to determine if the web-based intervention can
- strengthen patient autonomy and empowerment,
- promote informed decisions on immunotherapy,
- improve quality of life,
- reduce anxiety and depression,
- increase physical activity and a healthy diet,
- increase effectiveness of neurologists encounters,
- and save health care costs.
In order to develop and evaluate the intervention, a multiphase mixed-methods study covering the first three phases of the Medical Research Council Framework for complex interventions will be conducted. After development, the intervention programme will be pretested and piloted with experts and persons with MS (pwMS). The intervention will be evaluated in a randomized controlled trial (RCT) with 328 patients with early MS (< 12 months), who have at least two MS-typical lesions. Study participants will be recruited in 19 MS centres across Germany and randomised to an intervention group with access to an evidence-based information platform or to a control group with optimised standard care based on material of the German Multiple Sclerosis Society (DMSG). The primary endpoint will be reached if new T2 lesions or relapses occur. Furthermore, a mixed methods process evaluation and a health economic evaluation will be carried out.
Recalculated sample size: Based on a blinded data export of August 16th, 2021, with data on event rates (primary endpoint: new T2 lesion or new relapse) of 135 included patients at that time, a blinded sample size recalculation was performed. The sample size recalculation resulted in a lower number of necessary cases due to high event rates (51 primary endpoint events at that time). The calculation of event rates and an assumed dropout rate of 20% resulted in a case number of 216 patients that have to be randomized (108 per group) instead of 328.
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
| Arm | Type | Receives |
|---|---|---|
| EBBC programme | Experimental | Behavioral: EBBC programmeParticipants in the intervention group will receive access to evidence-based patient information (EBPI) about lifestyle factors in MS combined with a complex behaviour change programme (EBBC programme), an online tool that was developed in line with principles of patient empowerment and cognitive behavioural therapy (CBT) approaches, including acceptance and mindfulness oriented techniques. |
| Control group programme | Active comparator | Behavioral: Control group programmeParticipants randomized to the active control group will receive access to an information platform with optimized standard care consisting of information compiled from the German Multiple Sclerosis Society (DMSG) information material to reflect current practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- signed informed consent
- clinically isolated syndrome (CIS), suspected or confirmed MS for less than 12 months
- at least two MS-typical lesions on T2-weighted images on MRI scans
- MS typical cerebrospinal fluid (CSF) finding with detection of oligoclonal bands
- access to the internet and ability to use websites
Key exclusion criteria (5 listed)
- corticosteroid therapy within 4 weeks prior to study inclusion
- substantial psychiatric disorder (based on clinical impression)
- severe cognitive deficit affecting information uptake (based on clinical impression)
- pregnancy
- claustrophobia
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 |
|---|---|---|
| EBBC programmeWeb-based behavioural lifestyle intervention that provides patients with coordinated information based on their existing health beliefs, interests, etc. In the programme, techniques and exercises will be taught in sequentially active interactive learning units ("simulated dialogues") and followed-up with email and SMS reminders in the second study year. The following topics will be focused on: 1. Diagnosis and disease progression 2. Support in disease processing 3. Techniques for coping with stress and depressive symptoms as well as developing positive emotions 4. Optimisation of dietary behaviour 5. Optimisation of physical activity behaviour 6. Sleep hygiene and methods for dealing with insomnia. The programme will accompany each patient with information material and e-mail reminders over a period of 12 months with initial 2-3 weekly tasks, later only weekly reminders and inputs every 2 weeks. All in all, the intervention programme will consist of 16 modules. | Behavioural | EBBC programme |
| Control group programmeWeb-based information platform with optimized standard care compiled from information material of the German Multiple Sclerosis Society (DMSG). Information will be provided in sequentially activated modules over a period of 12 months, covering the following topics: 1. Disease progression 2. Invisible symptoms of multiple sclerosis 3. Symptomatic therapy 4. Immunotherapy decision support 5. Coping strategies 6. Autonomy 7. Fatigue 8. Quality of life 9. Physical activity 10. Nutritional behaviour In addition, a reminder system with neutral e-mail reminders will be used to promote the use of the programme. | Behavioural | Control group programme |
Primary outcome
Occurrence of new lesions on T2-weighted images on MRI scans
Time frame: Change in the number of lesions on T2-weighted images from immediately after patient inclusion (month 0), to month 3, 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion
As a surrogate for inflammatory disease activity, new T2 lesions will be assessed in MRI. MRI protocol: Localizer, 3D FLAIR sagittal e.g. 3x3mmm, 3D image T1w native sagittal, 1-3mm, PD/T2w axial 3mm, protocol duration approx. 20 min.
Time to a second relapse
Time frame: Change in relapse status from baseline (no endpoint), to month 1, 3, 6, 12, 18 (follow-up), and 24 (follow-up) after patient inclusion
Duration of complaints/impairment, relapse symptoms (worsened or newly occurred), degree of impairment due to the relapse and degree of certainty with regard to the classification of the worsening as a relapse.
18 secondary outcomes
Risk Knowledge (RiKno10)
Time frame: Month 3 after patient inclusion
Control Preference Scale (CPS)
Time frame: Month 12 after patient inclusion, as well as after reaching the primary endpoint
Immunotherapy Decision Satisfaction Questionnaire
Time frame: After reaching the primary endpoint
Immunotherapy Status Questionnaire
Time frame: Baseline (no endpoint), month 1, 3, 6, 12, 18 (follow-up), 24 (follow-up) after patient inclusion
Patient Activation Measure (PAM)
Time frame: Baseline and month 12 after patient inclusion
Coping self-efficacy (CSE) scale
Time frame: Baseline and month 12 after patient inclusion
Changes in Perceived Empowerment Questionnaire
Time frame: Month 12 after patient inclusion
Credibility/Expectancy Questionnaire
Time frame: 4 weeks after patient inclusion (month 1)
Readiness to Change (stage assessment) based on the Health Action Process Approach (HAPA)
Time frame: Baseline, month 3 and 12 after patient inclusion
Impairment in the Expanded Disability Status Scale (EDSS)
Time frame: Baseline and month 12 after patient inclusion
Hamburg Quality of life in MS Scale (HAQUAMS)
Time frame: Baseline and month 12 after patient inclusion
EQ-5D
Time frame: Baseline, month 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion
Hospital anxiety and distress scale (HADS)
Time frame: Baseline and month 12 after patient inclusion
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: Baseline and month 12 after patient inclusion
Physical Activity, Exercise, and Sport Questionnaire (Bewegungs- und Sportaktivität Fragebogen (BSA-F))
Time frame: Baseline and month 12 after patient inclusion
Questionnaire of Healthy Diet (QHOD2), adapted version of the Mediterranean Diet Screener (aMDS)
Time frame: Baseline, month 3 and 12 after patient inclusion
24-h dietary recall myfood24
Time frame: Baseline and month 12 after patient inclusion, in each case three times within two to three weeks (two weekdays and one weekend day)
Health Economic Evaluation
Time frame: Baseline, month 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 33593774Krause N, Riemann-Lorenz K, Steffen T, Rahn AC, Pottgen J, Stellmann JP, Kopke S, Friede T, Icks A, Vomhof M, Temmes H, van de Loo M, Gold SM, Heesen C. Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1). BMJ Open. 2021 Feb 16;11(2):e041720. doi: 10.1136/bmjopen-2020-041720.
- Individual participant dataSharing planned: Yes. An anonymized individual data set will be published in major journals in order to disseminate the study results. In addition, all trial results will be communicated at scientific conferences and meetings by the investigators and presented on the DMSG website and other relevant patient websites.
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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. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBBC programme in people with Multiple Sclerosis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of new lesions on T2-weighted images on MRI scans (time frame: Change in the number of lesions on T2-weighted images from immediately after patient inclusion (month 0), to month 3, 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion). The study lists 2 primary outcomes in all. 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 NCT03968172, which also lists 1 linked publication.
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 13 Sep 2023.