Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1)
Autor: | Tim Friede, Sascha Köpke, Tanja Steffen, Christoph Heesen, Jan-Patrick Stellmann, Herbert Temmes, Nicole Krause, Stefan M. Gold, Karin Riemann-Lorenz, Markus Vomhof, Markus van de Loo, Andrea Icks, Jana Pöttgen, Anne Christin Rahn |
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Rok vydání: | 2021 |
Předmět: |
medicine.medical_specialty
Multiple Sclerosis Cost-Benefit Analysis medicine.medical_treatment Disease law.invention Young Adult 03 medical and health sciences 0302 clinical medicine information technology Randomized controlled trial law Germany medicine Clinical endpoint magnetic resonance imaging Humans 030212 general & internal medicine Life Style Randomized Controlled Trials as Topic clinical trials Internet Clinically isolated syndrome business.industry Public health public health General Medicine 3. Good health Clinical trial Neurology Economic evaluation Physical therapy business 030217 neurology & neurosurgery Watchful waiting |
Zdroj: | BMJ Open |
ISSN: | 2044-6055 |
Popis: | 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 analysisA 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 disseminationThe 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 numberClinicalTrials.gov Registry (NCT03968172); Pre-results. |
Databáze: | OpenAIRE |
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