Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Interactive Web Platform for EmPOWERment in Early Multiple Sclerosis (POWER@MS1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03968172
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : August 5, 2020
Sponsor:
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)
Deutsche Multiple Sklerose Gesellschaft (DMSG) Landesverband Berlin e.V.
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: EBBC programme Behavioral: Control group programme Not Applicable

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 16 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study will be conducted as an investigator blinded trial and participating physicians as well as MS centres in general will not be provided with any information about the group assignment. Randomisation will take place only after baseline documentation. Blinding of the trial participants is pursued, but only possible to a limited extent. Furthermore, it cannot be prevented that patients discuss the intervention contents with their physician. Thus, participants and neurologist might realize their participation in the intervention group. While blinding in behavioural interventions is virtually not possible, the only strategy to increase similarity of groups is to have an active control group which we aim for with the optimized standard care group.
Primary Purpose: Supportive Care
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
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EBBC programme
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.
Behavioral: EBBC programme

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:

  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.


Active Comparator: Control group programme
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.
Behavioral: Control group programme

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:

  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.





Primary Outcome Measures :
  1. 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.


  2. 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.


Secondary Outcome Measures :
  1. Risk Knowledge (RiKno10) [ Time Frame: Month 3 after patient inclusion ]
    To assess risk knowledge, RiKno 2.0 was adapted to a 10-item version (RiKno10).

  2. Control Preference Scale (CPS) [ Time Frame: Month 12 after patient inclusion, as well as after reaching the primary endpoint ]
    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.

  3. Immunotherapy Decision Satisfaction Questionnaire [ Time Frame: After reaching the primary endpoint ]
    As a surrogate of decision quality, satisfaction with the immunotherapy decision will be assessed.

  4. Immunotherapy Status Questionnaire [ Time Frame: Baseline (no endpoint), month 1, 3, 6, 12, 18 (follow-up), 24 (follow-up) after patient inclusion ]
    It will be assessed whether an immunotherapy was newly started, aborted or changed.

  5. Patient Activation Measure (PAM) [ Time Frame: Baseline and month 12 after patient inclusion ]
    Assessment of patient activation development (i.e. expressed in the confidence and knowledge to take action, as well as actually taking health-related action).

  6. Coping self-efficacy (CSE) scale [ Time Frame: Baseline and month 12 after patient inclusion ]
    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.

  7. Changes in Perceived Empowerment Questionnaire [ Time Frame: Month 12 after patient inclusion ]
    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.

  8. Credibility/Expectancy Questionnaire [ Time Frame: 4 weeks after patient inclusion (month 1) ]
    Selected items measuring treatment expectancy and credibility.

  9. Readiness to Change (stage assessment) based on the Health Action Process Approach (HAPA) [ Time Frame: Baseline, month 3 and 12 after patient inclusion ]
    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.

  10. Impairment in the Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline and month 12 after patient inclusion ]
    MS impairment measurement with a score ranging from 0.0 (normal neurological exam) to 10.0 (death due to MS).

  11. Hamburg Quality of life in MS Scale (HAQUAMS) [ Time Frame: Baseline and month 12 after patient inclusion ]
    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.

  12. EQ-5D [ Time Frame: Baseline, month 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion ]
    Assessment of health-related quality of life.

  13. Hospital anxiety and distress scale (HADS) [ Time Frame: Baseline and month 12 after patient inclusion ]
    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.

  14. Godin Leisure-Time Exercise Questionnaire (GLTEQ) [ Time Frame: Baseline and month 12 after patient inclusion ]
    Amount of mild, moderate and strenuous exercise in leisure time.

  15. Physical Activity, Exercise, and Sport Questionnaire (Bewegungs- und Sportaktivität Fragebogen (BSA-F)) [ Time Frame: Baseline and month 12 after patient inclusion ]
    Assessment of physical activity, including occupational activity, leisure time activity and sports.

  16. Questionnaire of Healthy Diet (QHOD2), adapted version of the Mediterranean Diet Screener (aMDS) [ Time Frame: Baseline, month 3 and 12 after patient inclusion ]
    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.

  17. 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) ]
    Aggregated nutrient intake data (e.g. omega-3-fatty acids).

  18. Health Economic Evaluation [ Time Frame: Baseline, month 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion ]
    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.



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • treatment with Alemtuzumab, Ocrelizumab, Natalizumab, Cladribin or Fingolimod
  • treatment with glatiramer acetate, teriflunomide, dimethylfumarate or interferons within six months prior to study inclusion
  • corticosteroid therapy within 4 weeks prior to study inclusion
  • planned treatment start within 3 months after study inclusion
  • substantial psychiatric disorder (based on clinical impression)
  • severe cognitive deficit affecting information uptake (based on clinical impression)
  • pregnancy
  • claustrophobia

Information from the National Library of Medicine

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): NCT03968172


Contacts
Layout table for location contacts
Contact: Christoph Heesen, Prof. +4940-7410-54076 heesen@uke.de
Contact: Nicole Krause +4940-7410-54077 n.krause@uke.de

Locations
Layout table for location information
Germany
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Christoph Heesen, Prof.    +4940-7410-54076    heesen@uke.de   
Contact: Nicole Krause    +4940-7410-54077    n.krause@uke.de   
Principal Investigator: Christoph Heesen, Prof.         
Sub-Investigator: Nicole Krause         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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)
Deutsche Multiple Sklerose Gesellschaft (DMSG) Landesverband Berlin e.V.
Investigators
Layout table for investigator information
Principal Investigator: Christoph Heesen, Prof. Universitätsklinikum Hamburg-Eppendorf
Layout table for additonal information
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03968172    
Other Study ID Numbers: POWER@MS1
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Multiple Sclerosis
Complex Intervention
Lifestyle Intervention
Randomized Controlled Trial
Evidence-based Medicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases