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RebiQoL: A randomized trial of telemedicine patient support program for health-related quality of life and adherence in people with MS treated with Rebif
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Landtblom: Neurology.ORCID iD: 0000-0001-9567-470x
Merck AB, Stockholm, Sweden; Stockholm Univ, Dept Biochem & Biophys, Sci Life Lab, Solna, Sweden.ORCID iD: 0000-0003-2245-7557
Karolinska Inst, Danderyd Hosp, Div Internal Med, Neurol Unit, Stockholm, Sweden.
Skåne Univ Hosp, Dept Neurol, Malmö, Sweden.
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2019 (English)In: PLoS ONE, ISSN 1932-6203, E-ISSN 1932-6203, Vol. 14, no 7, article id e0218453Article in journal (Refereed) Published
Abstract [en]

RebiQoL was a phase IV multicenter randomized study to assess the impact of a telemedicine patient support program (MSP) on health-related quality of life (HRQoL) in patients with relapsing-remitting MS (RRMS) being administered with Rebif with the RebiSmart device. The primary endpoint was to assess the impact of MSP compared to patients only receiving technical support for RebiSmart on HRQoL at 12 months, using the psychological part of Multiple Sclerosis Impact Scale (MSIS-29), in patients administered with Rebif. A total of 97 patients diagnosed with RRMS were screened for participation in the study of which 3 patients did not fulfill the eligibility criteria and 1 patient withdrew consent. Of the 93 randomized patients, 46 were randomized to MSP and 47 to Technical support only. The demographic characteristics of the patients were well-balanced in the two arms. There were no statistical differences (linear mixed model) in any of the primary (difference of 0.48, 95% CI: -8.30-9.25, p = 0.91) or secondary outcomes (p>0.05). Although the study was slightly underpowered, there was a trend towards better adherence in the MSP group (OR 3.5, 95% CI 0.85-14.40, p = 0.08) although not statistically significant. No unexpected adverse events occurred. This study did not show a statistically significant effect of the particular form of teleintervention used in this study on HRQoL as compared to pure technical support, for MS patients already receiving Rebif with the RebiSmart device.

Trial Registration: ClinicalTrials.gov: NCT01791244.

Place, publisher, year, edition, pages
2019. Vol. 14, no 7, article id e0218453
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Neurology
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URN: urn:nbn:se:uu:diva-389751DOI: 10.1371/journal.pone.0218453ISI: 000484936300017PubMedID: 31276502OAI: oai:DiVA.org:uu-389751DiVA, id: diva2:1338619
Available from: 2019-07-23 Created: 2019-07-23 Last updated: 2019-10-18Bibliographically approved

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