Artikel
Communication, Coordination, and Security for people with Multiple Sclerosis (COCOS-MS): a randomised phase II clinical trial protocol
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Veröffentlicht: | 27. September 2021 |
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Background and status of (inter)national research: 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. MS patients are likely to depend on multiple health care 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 (CM) improves the quality of life (QoL), functional status and reduces service use, such benefits have not yet been investigated in severely affected MS patients. In this explorative phase ll clinical trial, we will evaluate a care and case management (CCM) with long-term, cross-sectoral and outreaching services and consider the unit of care (patients and caregivers).
Question and objective: This trial’s primary objective is to examine the effects of a comprehensive cross-sectoral, long-term patient advocacy CCM for severely affected MS patients with complex needs and their caregivers on patients’ QoL. Secondary objectives include patients’ a) treatment-related risk perception, b) palliative care needs, c) anxiety and depression, d) use of health care services, caregivers’ e) burden and f) QoL, g) meeting patients’ and caregivers’ needs through CCM, and h) evaluation of the CCM intervention. We will also evaluate CCM through individual interviews with a subset of patients and caregivers and focus groups or individual in-depth interviews with health care professionals. The explorative approach (phase ll clinical trial) with embedded qualitative research will allow for developing a final design for a confirmative phase lll trial.
Method: The trial is a single-centre, phase II, two arms, randomised, controlled, rater-blinded, parallel-group clinical trial evaluating the effects of a cross-sectoral, long-term patient advocacy CCM for severely affected MS patients with complex needs and their caregivers. Eighty MS patients and their caregivers will be randomly assigned to either the control (standard care) or the intervention group (standard care plus CCM (for 12 months)). The intervention comprises monthly personal visits wherever the patient (and caregiver, if any) is (e.g., at home) and weekly telephone calls. Irrespective of group allocation, regular data assessments will be done at baseline and then at 3-months intervals, including one last follow-up after the intervention has ended.