Interactive Web Platform for EmPOWERment in Early Multiple Sclerosis

NCT03968172 | Completed DMC

• 1 other identifier: POWER@MS1
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Complex Intervention; Lifestyle Intervention; Randomized Controlled Trial; Evidence-based Medicine

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  Month 3 after patient inclusion

• Control Preference Scale (CPS)

  Month 12 after patient inclusion, as well as after reaching the primary endpoint

• Immunotherapy Decision Satisfaction Questionnaire

  After reaching the primary endpoint

• Immunotherapy Status Questionnaire

  Baseline (no endpoint), month 1, 3, 6, 12, 18 (follow-up), 24 (follow-up) after patient inclusion

• Patient Activation Measure (PAM)

  Baseline and month 12 after patient inclusion

Study Arms (2)

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.

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.

Behavioral: Control group programme

Interventions

EBBC programme BEHAVIORAL

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.

EBBC programme

Control group programme BEHAVIORAL

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.

Control group programme

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• substantial psychiatric disorder (based on clinical impression)
• severe cognitive deficit affecting information uptake (based on clinical impression)
• pregnancy
• claustrophobia

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Charite University, Berlin, Germany: collaborator
• University of Cologne: collaborator
• University Medical Center Goettingen: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• Gaia AG: collaborator
• BKK Dachverband e.V.: collaborator
• Deutsche Multiple Sklerose Gesellschaft (DMSG): collaborator

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

• 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.

  PMID: 33593774 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Christoph Heesen, Prof.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 30, 2019
• Study Start: July 1, 2019
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)