Universität zu Köln

Krause, Nicole ORCID: 0000-0001-6681-7054, Riemann-Lorenz, Karin ORCID: 0000-0002-0779-2640, Steffen, Tanja, Rahn, Anne Christin, Pottgen, Jana, Stellmann, Jan-Patrick ORCID: 0000-0003-2565-2833, Kopke, Sascha ORCID: 0000-0003-4106-4919, Friede, Tim ORCID: 0000-0001-5347-7441, Icks, Andrea, Vomhof, Markus ORCID: 0000-0002-2714-6371, Temmes, Herbert, van de Loo, Markus, Gold, Stefan M. and Heesen, Christoph (2021). Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1). BMJ Open, 11 (2). LONDON: BMJ PUBLISHING GROUP. ISSN 2044-6055

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Abstract

Introduction Multiple 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Krause, Nicole UNSPECIFIED orcid.org/0000-0001-6681-7054 UNSPECIFIED Riemann-Lorenz, Karin UNSPECIFIED orcid.org/0000-0002-0779-2640 UNSPECIFIED Steffen, Tanja UNSPECIFIED UNSPECIFIED UNSPECIFIED Rahn, Anne Christin UNSPECIFIED UNSPECIFIED UNSPECIFIED Pottgen, Jana UNSPECIFIED UNSPECIFIED UNSPECIFIED Stellmann, Jan-Patrick UNSPECIFIED orcid.org/0000-0003-2565-2833 UNSPECIFIED Kopke, Sascha UNSPECIFIED orcid.org/0000-0003-4106-4919 UNSPECIFIED Friede, Tim UNSPECIFIED orcid.org/0000-0001-5347-7441 UNSPECIFIED Icks, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Vomhof, Markus UNSPECIFIED orcid.org/0000-0002-2714-6371 UNSPECIFIED Temmes, Herbert UNSPECIFIED UNSPECIFIED UNSPECIFIED van de Loo, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED Gold, Stefan M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Heesen, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-600169
DOI:	10.1136/bmjopen-2020-041720
Journal or Publication Title:	BMJ Open
Volume:	11
Number:	2
Date:	2021
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	2044-6055
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PHYSICAL-ACTIVITY; DEPRESSION; STRESS; QUESTIONNAIRE; DISABILITY; DIAGNOSIS; VALIDITY; ANXIETY; HELP Multiple languages Medicine, General & Internal Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/60016