Development and Evaluation of a Web-based Programme on Relapse Management for People With Multiple Sclerosis

NCT04233970 | Completed DMC

• 1 other identifier: POWER@MS2
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will evaluate a web-based relapse management programme, which is easily accessible for people with multiple sclerosis. The trial is accompanied by a mixed-methods process evaluation and a health economic evaluation. It is expected that the programme will positively change patients' relapse management and strengthen their autonomy and participation.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; Relapsing Remitting; Relapse Management; Steroids; Autonomy

Outcome Measures

Primary Outcomes (1)

• Assessment of change in relapse treatment (relapses not treated or treated with oral steroids).

  Standardized questionnaire to assess change of relapses and their treatment. The questionnaire will be applied during 3-monthly phone interviews.

  Telephone interview at month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 after patient inclusion and after final patient reaches month 12

Secondary Outcomes (11)

• Annual relapse rate

  Telephone interview at month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 after patient inclusion and after final patient reaches month 12

• Relapse Risk Knowledge

  Month 3 and 12 after patient inclusion

• Planned Behaviour in MS Scale (PBMS relapse)

  Month 3 and 12 after patient inclusion

• Control Preference Scale relapse (CPS relapse)

  Month 3 after patient inclusion

• Patient Activation Measure (PAM)

  Baseline, month 3, 12, 24, 30, 36 after patient inclusion and after final patient reaches month 12

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants randomized to the intervention group will receive access to the multi-component, web-based intervention programme. The intervention programme will be developed in line with principles of patient empowerment and based on the Theory of Planned Behaviour.

Behavioral: web-based intervention programme

Control group

ACTIVE COMPARATOR

Participants randomized to the control group will receive access to the web-based control programme with optimized standard care.

Behavioral: web-based information material offered via the same platform (broca®) in addition to usual care

Interventions

web-based intervention programme BEHAVIORAL

The intervention will be designed as an individualized, dialogue-based system that will provide PwMS coordinated, individually tailored information based on the software platform broca®. The intervention programme will consist of three sections: 1. EBPI/decision aid (five modules plus decision aid in case of an acute relapse) provided by the broca® programme. The key element of the EBPI/decision aid is the information on glucocorticosteroids for the treatment of acute relapses. 2. A webinar led via WebEx by a trained MS nurse with questioning/chat session (approx. 60-75min). 3. A supervised chat room provided via the DMSG (https://www.dmsg.de/ms-connect). In addition, email reminders will be used to enhance involvement of participants.

Intervention group

web-based information material offered via the same platform (broca®) in addition to usual care BEHAVIORAL

Participants in the control group will have access to web-based information material offered via the same platform (broca®) in addition to usual care. The control group intervention will be based on material of the German Multiple Sclerosis Society (DMSG) on relapse management. The programme will accompany the participants over a period of 4 weeks and a reminder system with neutral e-mail reminders will be used to promote the use of the programme.

Control group

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 syndrom, suspected or diagnosed relapsing remitting MS
• at least 1 relapse in the last year and/or at least 2 relapses in the last 2 years
• access to the internet and ability to use websites

You may not qualify if:

• primary progressive MS
• secondary progressive MS
• acute relapse
• severe visual impairment
• severe psychiatric disorder (judged based on clinical impression)
• allergic hypersensitivity to corticosteroids
• participation in the EBSIMS training programme (the relapse management training programme was offered in Hamburg and Bad Segeberg)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• University of Cologne: collaborator
• University Medical Center Goettingen: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• Gaia AG: collaborator
• Deutsche Multiple Sklerose Gesellschaft (DMSG), Bundesverband e.V.: collaborator
• MS-Stiftung Trier: collaborator
• BBK Dachverband e.V.: collaborator

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (17)

• Kopke S, Kasper J, Muhlhauser I, Nubling M, Heesen C. Patient education program to enhance decision autonomy in multiple sclerosis relapse management: a randomized-controlled trial. Mult Scler. 2009 Jan;15(1):96-104. doi: 10.1177/1352458508095921. Epub 2008 Oct 9.

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• Kopke S, Richter T, Kasper J, Muhlhauser I, Flachenecker P, Heesen C. Implementation of a patient education program on multiple sclerosis relapse management. Patient Educ Couns. 2012 Jan;86(1):91-7. doi: 10.1016/j.pec.2011.03.013. Epub 2011 Apr 19.

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• 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.

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• Ajzen I. The theory of planned behaviour: reactions and reflections. Psychol Health. 2011 Sep;26(9):1113-27. doi: 10.1080/08870446.2011.613995.

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• Kopke S, Kern S, Ziemssen T, Berghoff M, Kleiter I, Marziniak M, Paul F, Vettorazzi E, Pottgen J, Fischer K, Kasper J, Heesen C. Evidence-based patient information programme in early multiple sclerosis: a randomised controlled trial. J Neurol Neurosurg Psychiatry. 2014 Apr;85(4):411-8. doi: 10.1136/jnnp-2013-306441. Epub 2013 Oct 8.

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• Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.

  PMID: 18824488 BACKGROUND

• Wenzel L, Heesen C, Peper J, Grentzenberg K, Fasshauer E, Scheiderbauer J, Thale F, Meyer B, Kopke S, Rahn AC. An interactive web-based programme on relapse management for people with multiple sclerosis (POWER@MS2) - development, feasibility, and pilot testing of a complex intervention. Front Neurol. 2022 Sep 23;13:914814. doi: 10.3389/fneur.2022.914814. eCollection 2022.

  PMID: 36212638 DERIVED

• Wenzel L, Heesen C, Scheiderbauer J, van de Loo M, Kopke S, Rahn AC. Evaluation of an interactive web-based programme on relapse management for people with multiple sclerosis (POWER@MS2): study protocol for a process evaluation accompanying a randomised controlled trial. BMJ Open. 2021 Oct 1;11(10):e046874. doi: 10.1136/bmjopen-2020-046874.

  PMID: 34598981 DERIVED

• Rahn AC, Wenzel L, Icks A, Stahmann A, Scheiderbauer J, Grentzenberg K, Vomhof M, Montalbo J, Friede T, Heesen C, Kopke S. Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)-study protocol for a randomised controlled trial. Trials. 2021 Feb 14;22(1):139. doi: 10.1186/s13063-021-05059-1.

  PMID: 33583424 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; 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

• Sascha Köpke, Prof.

  Institute of Nursing Science, University of Cologne

  PRINCIPAL INVESTIGATOR

• Anne C Rahn, Prof.

  Institute of Social Medicine and Epidemiology, Nursing Research Unit, University of Lübeck

  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 group assignment. Randomization 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 neurologists might realize their group assignment. While blinding in complex educational interventions including a webinar 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. Furthermore, the outcome assessors are blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 18, 2020
• Study Start: February 17, 2020
• Primary Completion: April 30, 2023
• Study Completion: May 5, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DE (1)