Evidence map›Paper›PMID 40554666›Full record

Trial reportDeutsches Arzteblatt international2025

Communication, Coordination, and Security for People With Multiple Sclerosis (COCOS-MS): A Randomized, Phase II Trial of Cross-sectoral Care and Case Management.

Heidrun Golla, Veronika Dunkl, Anne Dorr, Yasemin Goereci, Fabian Hebben, Wiebke Müller, Kim Dillen, Daniele Civello, Dirk Müller, Alexander Stahmann and 6 more

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Deutsches Arzteblatt international, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Heidrun GollaDepartment of Palliative Medicine, University of Cologne, Faculty of Medicine and University Hospital, Cologne, Germany; Department of Palliative Medicine, University Medical Center Göttingen, Göttingen, Germany; Department of Neurology, University of Cologne, Faculty of Medicine and University Hospital, Cologne, Germany; Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Faculty of Medicine and University Hospital, Cologne, Germany; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany; Philipps University Marburg and Department of Neurology, University Hospital Gießen and Marburg, Baldingerstraße, Marburg, Germany; Department of Palliative Medicine, University of Cologne, Faculty of Medicine and University Hospital, Cologne, Germany; Department of Neurology, University of Cologne, Faculty of Medicine and University Hospital, Cologne, Germany; Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Faculty of Medicine and University Hospital, Cologne, Germany; Institute of Health Economics and Clinical Epidemiology, University of Cologne and University Hospital of Cologne; The MS Registry of the German Multiple Sclerosis Society (DMSG), MS Research and Project Development, Hanover; Center for Integrated Oncology Aachen Bonn Cologne Dusseldorf (CIO ABCD), University of Cologne, Prof. Dr. med. Raymond Voltz; Center for Health Services Research Cologne (ZVFK), University of Cologne; German Society of Care and Case Management (DGCC), Münster; Institute for Neurosciences and Medicine 3, Cognitive Neurology, Research Center Julich.
Veronika Dunkl
Anne Dorr
Yasemin Goereci
Fabian Hebben
Wiebke Müller
Kim Dillen
Daniele Civello
Dirk Müller
Alexander Stahmann
Raymond Voltz
Peter Löcherbach
Gereon Rudolf Fink
Martin Hellmich
Clemens Warnke
the KOKOS-MS Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeople 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.

methodsWe 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.

results80 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.

conclusionThe 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.

Indexed as

Case ManagementMultiple SclerosisAdultFeasibility StudiesFemaleHumansMaleMiddle AgedPalliative CareQuality of Life

Identifiers

PMID40554666
PMCPMC12599190

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.