Clinical trial NCT03097146: Managing Aftercare for Stroke (MAS): MAS-II - A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients
Official title: Managing Aftercare for Stroke (MAS): MAS-II - A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Aftercare
Comprehensive Care
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Center for Stroke Research Berlin
name: Hebrew University of Jerusalem
name: NeuroCure Clinical Research Center, Charite, Berlin
First posted: 2017-03-31
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: After discharge from hospital, the current healthcare system in Germany allows considerable flexibility (therefore complexity) of patient access and mobility between multiple care providers in the community setting. The investigators believe this aftercare could be better coordinated by a specialized coordinated stroke aftercare service. Comprehensive coordinated multidisciplinary care is a proven concept with proven benefits in both acute and rehabilitation care provided in stroke units and neurorehabilitation centres. In this study, the investigators postulate that a similar coordinated approach to care can be extended to the phase after in-patient rehabilitation has ended (i.e. "long-term management" as opposed to "early supported discharge") for disabled patients with stroke living in the community.


Eligibility criteria: Inclusion Criteria:

* Patients with ischemic stroke
* Age ≥18 years
* At the time of V1 completion of rehabilitation or no rehabilitation planned
* Informed consent signed by patient or legal representative
* stroke patients with a stratified mRS score
* within six months after the index event

Exclusion Criteria:

* Unwillingness to participate in "AmbulanzPartner"
* Unwilling to have pseudonymized data stored, analysed, and anonymously published
* Patients being committed to psychiatric institutions or prisons

Primary outcomes:
measure: "EuroQol five dimensions questionnaire" (EuroQoL-5D)
timeFrame: 12 Months
Secondary outcomes:
measure: Post Stroke Checklist (PSC)
timeFrame: 12 Months
measure: modified Rankin Scale (mRS)
timeFrame: 12 Months
measure: Barthel-Index (BI)
timeFrame: 12 Months
measure: modified Ashworth Scale (mAS)
timeFrame: 12 Months
measure: Pain Detect (PD-Q)
timeFrame: 12 Months
measure: Freiburg questionnaire for coping (FKV)
timeFrame: 12 Months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 12 Months
measure: partial Aachen Aphasia Test (AAT)
timeFrame: 12 Months
measure: Hamilton rating scale for depression
timeFrame: 12 Months
measure: "Morisky Medication Adherence Scale" (MMAS)
timeFrame: 12 Months
measure: "Nikolaus score for evaluation of social conditions" (SoS)
timeFrame: 12 Months
measure: "Häusliche Pflegeskala" (HPS)
timeFrame: 12 Months
measure: Hospital Anxiety Depression Scale (HADS)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: NeuroCure Clinical Research Center (NCRC), Charité
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andreas Meisel, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: