Clinical trial NCT03968172: Interactive Web Platform for EmPOWERment in Early Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Complex Intervention
Lifestyle Intervention
Randomized Controlled Trial
Evidence-based Medicine
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: University of Cologne
name: University Medical Center Goettingen
name: Heinrich-Heine University, Duesseldorf
name: Gaia AG
name: BKK Dachverband e.V.
name: Deutsche Multiple Sklerose Gesellschaft (DMSG)
First posted: 2019-05-30
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Occurrence of new lesions on T2-weighted images on MRI scans
timeFrame: 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
measure: Time to a second relapse
timeFrame: 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:
measure: Risk Knowledge (RiKno10)
timeFrame: Month 3 after patient inclusion
measure: Control Preference Scale (CPS)
timeFrame: Month 12 after patient inclusion, as well as after reaching the primary endpoint
measure: Immunotherapy Decision Satisfaction Questionnaire
timeFrame: After reaching the primary endpoint
measure: Immunotherapy Status Questionnaire
timeFrame: Baseline (no endpoint), month 1, 3, 6, 12, 18 (follow-up), 24 (follow-up) after patient inclusion
measure: Patient Activation Measure (PAM)
timeFrame: Baseline and month 12 after patient inclusion
measure: Coping self-efficacy (CSE) scale
timeFrame: Baseline and month 12 after patient inclusion
measure: Changes in Perceived Empowerment Questionnaire
timeFrame: Month 12 after patient inclusion
measure: Credibility/Expectancy Questionnaire
timeFrame: 4 weeks after patient inclusion (month 1)
measure: Readiness to Change (stage assessment) based on the Health Action Process Approach (HAPA)
timeFrame: Baseline, month 3 and 12 after patient inclusion
measure: Impairment in the Expanded Disability Status Scale (EDSS)
timeFrame: Baseline and month 12 after patient inclusion
measure: Hamburg Quality of life in MS Scale (HAQUAMS)
timeFrame: Baseline and month 12 after patient inclusion
measure: EQ-5D
timeFrame: Baseline, month 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion
measure: Hospital anxiety and distress scale (HADS)
timeFrame: Baseline and month 12 after patient inclusion
measure: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Baseline and month 12 after patient inclusion
measure: Physical Activity, Exercise, and Sport Questionnaire (Bewegungs- und Sportaktivität Fragebogen (BSA-F))
timeFrame: Baseline and month 12 after patient inclusion
measure: Questionnaire of Healthy Diet (QHOD2), adapted version of the Mediterranean Diet Screener (aMDS)
timeFrame: Baseline, month 3 and 12 after patient inclusion
measure: 24-h dietary recall myfood24
timeFrame: Baseline and month 12 after patient inclusion, in each case three times within two to three weeks (two weekdays and one weekend day)
measure: Health Economic Evaluation
timeFrame: Baseline, month 6, 12, 18 (follow-up) and 24 (follow-up) after patient inclusion
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Christoph Heesen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.