Evidence map›Paper›PMID 33593774›Full record

ArticleBMJ open2021

Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1).

Nicole Krause, Karin Riemann-Lorenz, Tanja Steffen, Anne Christin Rahn, Jana Pöttgen, Jan-Patrick Stellmann, Sascha Köpke, Tim Friede, Andrea Icks, Markus Vomhof and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03968172 (Development and Evaluation of a Web-based Lifestyle Intervention for EmPOWERment in Early Multiple Sclerosis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.4field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03968172 nacompletednot on this map

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

TypeinterventionalSponsorUniversitätsklinikum Hamburg-EppendorfRan2019 to 2023Enrolled234ConditionsMultiple SclerosisArmsEBBC programme, Control group programme
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 11 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 4 institutions in 2 countries.

Nicole KrauseInstitute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany n.krause@uke.de.ORCID 0000-0001-6681-7054
Karin Riemann-LorenzInstitute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0002-0779-2640
Tanja SteffenInstitute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Anne Christin RahnInstitute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0002-9051-3621
Jana PöttgenInstitute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0002-6665-2154
Jan-Patrick StellmannInstitute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0003-2565-2833
Sascha KöpkeUniversity of Cologne, Faculty of Medicine and University Hospital Cologe, Institute of Nursing Science, Cologne, Germany.ORCID 0000-0003-4106-4919
Tim FriedeDepartment of Medical Statistics, University Medical Centre Göttingen, Göttingen, Germany.ORCID 0000-0001-5347-7441
Andrea IcksInstitute for Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.ORCID 0000-0002-4882-969X
Markus VomhofInstitute for Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.ORCID 0000-0002-2714-6371
Herbert TemmesGerman Multiple Sclerosis Society, Federal Association, Hannover, Germany.
Markus van de LooGerman Multiple Sclerosis Society, Federal Association, Hannover, Germany.
Stefan M GoldInstitute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0001-5188-4799
Christoph HeesenInstitute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0001-8131-9467
Universität Hamburg · DEHeinrich Heine University Düsseldorf · DECarl von Ossietzky Universität Oldenburg · DEUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMultiple sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system that mainly affects young adults. Uncertainty is a major psychological burden of the disease from diagnosis to prognosis, enhanced by the pressure to make early decisions on a diverse set of immunotherapies. Watchful waiting for 1-2 years while adapting goals and lifestyle habits to life with a chronic disease represents another reasonable option for persons with MS (PwMS). A behaviour change programme based on evidence-based patient information (EBPI) is not available in standard care. This randomised controlled trial (RCT) with an embedded process evaluation investigates the efficacy and cost-effectiveness of a web-based behavioural lifestyle programme to change lifestyle behaviour and reduce inflammatory disease activity in PwMS. METHODS AND ANALYSIS: A web-based behavioural intervention will be evaluated in an RCT aiming to recruit 328 persons with clinically isolated syndrome, suspected MS or confirmed MS for less than 1 year, who have not yet started immunotherapy. Moreover, a mixed-methods process evaluation and a health economic evaluation will be carried out. Participants will be recruited in at least 16 MS centres across Germany and randomised to an intervention group with 12 months of access to EBPI about lifestyle factors in MS, combined with a complex behaviour change programme or to a control group (optimised standard care). The combined primary endpoint is the incidence of new T2 lesions on MRI or confirmed relapses. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (PV6015). Trial results will be communicated at scientific conferences and meetings and presented on relevant patient websites and in patient education seminars. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03968172); Pre-results.

Indexed as

Life StyleMultiple SclerosisCost-Benefit AnalysisGermanyHumansInternetRandomized Controlled Trials as TopicYoung Adultclinical trialsinformation technologymagnetic resonance imagingmultiple sclerosispublic health

Identifiers

PMID33593774
PMCPMC7888332
OpenAlexW3131446841

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.