Caregivers G35
Conditions
Interventions
Group 1: 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 p
Sponsors
Universität zu Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients' quality of life measured by the "HALEMS", which will be collected every three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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. | — |
Countries
Germany
Contacts
Public ContactVeronika Dunkl
Zentrum für Palliativmedizin
Outcome results
None listed