Golla, Heidrun, Dillen, Kim, Hellmich, Martin, Dojan, Thomas, Ungeheuer, Solveig, Schmalz, Petra, Stass, Angelika, Mildenberger, Vanessa, Goereci, Yasemin, Dunkl, Veronika ORCID: 0000-0001-6885-7666, Strupp, Julia, Fink, Gereon R. ORCID: 0000-0002-8230-1856, Voltz, Raymond, Stock, Stephanie, Cornely, Oliver, Stahmann, Alexander, Mueller, Anne, Loecherbach, Peter, Burghaus, Lothar ORCID: 0000-0002-7883-190X, Limmroth, Volker, Bonmann, Eckhard, Gerbershagen, Kathrin, Nelles, Gereon, Joist, Thomas, Haas, Judith, Temmes, Herbert and Warnke, Clemens ORCID: 0000-0002-3510-9255 (2022). Communication, Coordination, and Security for People with Multiple Sclerosis (COCOS-MS): a randomised phase II clinical trial protocol. BMJ Open, 12 (1). LONDON: BMJ PUBLISHING GROUP. ISSN 2044-6055

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Abstract

Introduction Patients with multiple sclerosis (MS) have complex needs that range from organising one's everyday life to measures of disease-specific therapy monitoring to palliative care. Patients with MS are likely to depend on multiple healthcare providers and various authorities, which are often difficult to coordinate. Thus, they will probably benefit from comprehensive cross-sectoral coordination of services provided by care and case management (CCM). Though studies have shown that case management improves quality of life (QoL), functional status and reduces service use, such benefits have not yet been investigated in severely affected patients with MS. In this explorative phase ll clinical trial, we evaluated a CCM with long-term, cross-sectoral and outreaching services and, in addition, considered the unit of care (patients and caregivers). Methods and analysis Eighty patients with MS and their caregivers will be randomly assigned to either the control (standard care) or the intervention group (standard care plus CCM (for 12 months)). Regular data assessments will be done at baseline and then at 3-month intervals. As primary outcome, we will evaluate patients' QoL. Secondary outcomes are patients' treatment-related risk perception, palliative care needs, anxiety/depression, use of healthcare services, caregivers' burden and QoL, meeting patients' and caregivers' needs, and evaluating the CCM intervention. We will also evaluate CCM through individual interviews and focus groups. The sample size calculation is based on a standardised effect of 0.5, and one baseline and four follow-up assessments (with correlation 0.5). Linear mixed models for repeated measures will be applied to analyse changes in quantitative outcomes over time. Multiple imputation approaches are taken to assess the robustness of the results. The explorative approach (phase ll clinical trial) with embedded qualitative research will allow for the development of a final design for a confirmative phase lll trial. Ethics and dissemination The trial will be conducted under the Declaration of Helsinki and has been approved by the Ethics Commission of Cologne University's Faculty of Medicine. Trial results will be published in an open-access scientific journal and presented at conferences.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Golla, HeidrunUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dillen, KimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hellmich, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dojan, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ungeheuer, SolveigUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmalz, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stass, AngelikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mildenberger, VanessaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goereci, YaseminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dunkl, VeronikaUNSPECIFIEDorcid.org/0000-0001-6885-7666UNSPECIFIED
Strupp, JuliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fink, Gereon R.UNSPECIFIEDorcid.org/0000-0002-8230-1856UNSPECIFIED
Voltz, RaymondUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stock, StephanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cornely, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stahmann, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, AnneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loecherbach, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burghaus, LotharUNSPECIFIEDorcid.org/0000-0002-7883-190XUNSPECIFIED
Limmroth, VolkerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bonmann, EckhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gerbershagen, KathrinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nelles, GereonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Joist, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haas, JudithUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Temmes, HerbertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Warnke, ClemensUNSPECIFIEDorcid.org/0000-0002-3510-9255UNSPECIFIED
URN: urn:nbn:de:hbz:38-681150
DOI: 10.1136/bmjopen-2021-049300
Journal or Publication Title: BMJ Open
Volume: 12
Number: 1
Date: 2022
Publisher: BMJ PUBLISHING GROUP
Place of Publication: LONDON
ISSN: 2044-6055
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
QUALITY-OF-LIFE; PALLIATIVE CARE; CASE-MANAGEMENT; UNMET NEEDS; DEPRESSION SCALE; HOSPITAL ANXIETY; CAREGIVERS; VALIDATION; BURDEN; HEALTHMultiple languages
Medicine, General & InternalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/68115

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