Communication, Coordination, and Security for People With Multiple Sclerosis (COCOS-MS): A randomized, phase II trial of cross-sectoral care and case management.
Background: People with severe multiple sclerosis (PsMS) have multidimensional, complex needs. COCOS-MS is an exploratory study of the effect of cross-sectoral care and case management (CCM) on these patients' quality of life, palliative care needs, and psychological distress, as well as caregivers'...
| Publicado en: | Deutsches Ärzteblatt International Vol. 122; no. 18; pp. 489 - 495 |
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| Autores principales: | , , , , , , , , , , , , , , |
| Formato: | Journal Article |
| Publicado: |
Deutscher Aerzte-Verlag GmbH
9/5/2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=188030322&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 188030322 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 18660452 5F0N jtl: Deutsches Ärzteblatt International issn: 18660452 maglogo: N pubinfo: dt: 9/5/2025 vid: 122 iid: 18 pid: 25312 pub: Deutscher Aerzte-Verlag GmbH artinfo: ui: 188030322 10.3238/arztebl.m2025.0097 188030322 ppf: 489 ppct: 6 formats: fmt: – @attributes: type: T – @attributes: type: C tig: atl: Communication, Coordination, and Security for People With Multiple Sclerosis (COCOS-MS): A randomized, phase II trial of cross-sectoral care and case management. aug: au: Golla, Heidrun Dunkl, Veronika Dorr, Anne Goereci, Yasemin Hebben, Fabian Müller, Wiebke Dillen, Kim Civello, Daniele Müller, Dirk Stahmann, Alexander Voltz, Raymond Löcherbach, Peter Fink, Gereon Rudolf Hellmich, Martin Warnke, Clemens affil: Department of Palliative Medicine, University of Cologne, Faculty of Medicine and University Hospital, Cologne, Germany sug: ab: Background: People with severe multiple sclerosis (PsMS) have multidimensional, complex needs. COCOS-MS is an exploratory study of the effect of cross-sectoral care and case management (CCM) on these patients' quality of life, palliative care needs, and psychological distress, as well as caregivers' burden. Methods: We conducted a randomized, controlled, phase II trial (DRKS00022771) with two parallel treatment arms: standard care versus CCM in addition to standard care over a 12-month period. A trial-specific CCM manual was used. The target variables were recorded in standardized fashion at baseline (T0) and every three months thereafter (T1 until the end of the intervention at T4, then T5 three months after the end of the intervention to determine sustainability). The primary endpoint was the change in the patients' quality of life (HALEMS) from baseline to month 12 in a group comparison. A modified intention-to-treat (mITT) was performed based on a mixed linear model with repeated measures over time (ARH1-structured covariance matrix). Values of p less than 0.05 were considered significant. Results: 80 PsMS were randomly assigned 1:1 to one of the two treatment arms (male: female 1:2, median age 55 years [IQR 49-62], EDSS 6.5 [6-7.5], dropout rate 10%). There was no significant improvement in HALEMS after one year (T4) in the group comparison (-0.08 [-0.31, 0.15], p = 0.503; NNT = 22). Secondary endpoints such as subjective health status, psychological distress, and palliative care needs showed a clear response at the end of the intervention. After the intervention ended, the values approached the baseline level. Conclusion: The primary endpoint did not reach significance in this health services research feasibility study. For further development of the study design, the focus will be on the psychological and palliative factors in which PsMS--a reference group for long-term neurological conditions--were found to benefit from the CCM. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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