Trial document




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  DRKS00022771

Trial Description

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Title

Communication, Coordination und Security for People with Multiple Sclerosis

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Trial Acronym

COCOS-MS

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URL of the Trial

http:///

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Brief Summary in Lay Language

Studies and own clinical experience show that severely affected MS patients and their relatives (hereinafter referred to as caregivers) often lack a continuous coordinating contact person who defines and organises their needs with them, advocates for their concerns and takes over control of all coordination tasks. Such tasks can be performed by a so-called "care and case manager". His/her activity is also known as "Care and Case Management", which has already been proven to simplify process control for various patient groups, improve quality of life and reduce social and healthcare costs. However, these positive effects have not yet been shown for severely affected MS patients and their caregivers. The aim of this study is to evaluate such a Care and Case Management service in severe MS over a long period of time (in this study over 12 months) in social and healthcare issues. The concerns of patients and their caregivers will be taken into account. This will done across all sectors, i.e. irrespective of whether patients are under outpatient or inpatient treatment. By conducting this study, we aim to improve the care of MS patients and their caregivers.

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Brief Summary in Scientific Language

To evaluate the implementation of a cross-sectoral Care and Case Management (CCM) for people with multiple sclerosis (MS). The CCM should help to identify severely affected patients, clarify their individual social and healthcare needs, find necessary service providers and coordinate them accordingly. The CCM controls the processes as a superordinate contact person in the existing care network and helps, for example, in dealing with authorities, doctors and therapists. If successful, the project will be the first to evaluate the benefits of a CCM for people with severe MS.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

/

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Organizational Data

  •   DRKS00022771
  •   2021/01/11
  •   [---]*
  •   yes
  •   Approved
  •   20-1436, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   G35 -  Multiple sclerosis
  •   Caregivers
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Interventions/Observational Groups

  •   In the intervention arm, MS patients and their caregivers will receive standard care within the existing health and social structures and an additional social advocacy CCM service that will personally visit patients and their caregivers at their wereabouts every three months and additionally also call every week.
    In addition, an outcome assessor will visit patients and caregivers every three months to comprehensively evaluate the impact of CCM on the quality of care using the HALEMS, IPOS/IPOS-Neuro, HADS, a cost booklet (patients), and the ZBI-12, SF-12 (caregivers).
  •   Patients assigned to the control arm will receive standard care within the existing healthcare and social structures.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Patients' quality of life measured by the "HALEMS", which will be collected every three months.

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Secondary Outcome

- Patients’ risk perception (self-designed risk perception questionnaire), palliative care needs (Integrated Palliative care Outcome Scale (IPOS) / Short Form Integrated Palliative care Outcome Scale for neurological conditions (8-item version) (IPOS Neuro-S8)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), use of health care services (self-designed cost booklet)
- Caregivers’ burden (Short Form Zarit Burden Interview (12-item version) (ZBI-12)) and quality of life (Short Form Health Survey (12-item version) (SF-12))
- Meeting patients’ and caregivers’ needs (part of self-designed CCM manual)

This data will be collected every three months. The CCM manual will also be used in a short form for the weekly telephone calls.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/01/19
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with:
1) Highly active MS with an indication for an escalating immunotherapeutic agent and being treated with such, and at least one of the following: age ≥ 50, expanded disability status scale (EDSS) ≥ 5 (Subgroup 1)
2a) Primary or secondary chronic progressive MS, age ≥ 18, EDSS 4-7, no immunotherapeutic treatment options (Subgroup 2a)
2b) Primary or secondary chronic progressive MS, age ≥ 18, EDSS > 7 (Subgroup 2b)

AND
- residence in the administrative district of Cologne
AND one of the following criteria applies:
- full command in understanding, reading, responding of German language skills and ability to give written informed consent
- if a patient is unable to give consent, a legal representative with a full command of the German language (understanding, reading, responding) and is able to give written informed consent can act on behalf of the patient

Caregivers:
- age ≥ 18
- responsible for caring for the patient
- full command of the German language (understanding, reading, responding)
- ability to give written informed consent

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Exclusion Criteria

- lack of consent to follow protocol
- current drug abuse, alcohol abuse or psychiatric illness, which, in the opinion of the trial physician obtaining informed consent, renders the patient or caregiver unfit for participation
- any kind of dependency on the PCI or sponsor (including being employed there)
- legal incapacity (caregivers only)

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Addresses

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    • Universität zu Köln
    • Albertus-Magnus-Platz
    • 50923  Köln
    • Germany
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    • Klinik und Poliklinik für Neurologie,Uniklinik Köln
    • Mr.  PD Dr.  Clemens  Warnke 
    • Köln
    • Germany
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    • Institut für Medizinische Statistik und Bioinformatik (IMSB) der Universität zu Köln
    • Mr.  Prof. Dr.  Martin  Hellmich 
    • Köln
    • Germany
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    • Zentrum für Klinische Studien (ZKS) der Universität zu Köln
    • Mr.  Prof. Dr.  Oliver  Cornely 
    • Köln
    • Germany
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    • Institut für Gesundheitsökonomie und klinische Epidemiologie (IGKE) der Universität zu Köln
    • Ms.  Prof. Dr.  Stephanie  Stock 
    • Köln
    • Germany
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    • Zentrum für Palliativmedizin
    • Ms.  PD Dr. med.  Heidrun  Golla 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Zentrum für Palliativmedizin
    • Ms.  Dr. med.  Veronika  Dunkl 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Luft- und Raumfahrt e.V. (DLR) vom Gemeinsamen Bundesausschuss (G-BA)
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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