Interactive Web Platform for EmPOWERment in Early Multiple Sclerosis

NCT ID: NCT03968172

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-04-05

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

EBBC programme

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Control group programme

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: collaborator

University Medical Center Goettingen

OTHER

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: collaborator

Gaia AG

INDUSTRY

Sponsor Role: collaborator

BKK Dachverband e.V.

UNKNOWN

Sponsor Role: collaborator

Deutsche Multiple Sklerose Gesellschaft (DMSG)

UNKNOWN

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Heesen, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 33593774 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

POWER@MS1

Identifier Type: -

Identifier Source: org_study_id