Clinical trial NCT00687869: Participative Rehabilitation in Stroke Patients
Official title: Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: stroke
rehabilitation
patient care management
patient participation
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt
name: Deutsche Rentenversicherung
name: Universitätsklinik und Poliklinik für Neurologie
First posted: 2008-06-02
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Primary objective of this study is to determine whether a case management of stroke patients after discharge to home or to nursing home results in improving physical and cognitive capacity one year after discharge.

Detailed description: In a randomized trial, the project Participative rehabilitation process management "Stroke in Saxony-Anhalt" (PaReSiS) implements a case management trial, explicitly including all providers in the course of illness, treatment and rehabilitation. To achieve this, patients in the intervention group have the opportunity to choose, specifically and according to their own needs, from the offers of a web portal and a telephone hotline, from individual counselling and info sessions as well as from home visits. Patients in the control group receive patient-information-notes beyond primary care. There will be qualitative interviews with the persons concerned and/or their relatives in both groups in order to validate the instruments.

Eligibility criteria: Inclusion Criteria:

* Acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding) with signs and symptoms of an acute stroke according to the diagnosis I61 and I63 of the ICD-10-GM 2008
* Differentiation between ischemic or haemorrhagic stroke by the use of CT or MRT
* Resident in Saxony-Anhalt or Saxony or Thuringia
* Able to understand German language

Exclusion Criteria:

* Reinfarction
* Alcoholism
* Death in acute care
* NIHHS \> 25
* Homelessness

Primary outcomes:
measure: physical scale of the Stroke Impact Scale 3.0
timeFrame: before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization
Secondary outcomes:
measure: Health related quality of life, depression, mortality, recurrent stroke and/or TIA/PRIND
timeFrame: before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)
Study officials:
affiliation: Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)
name: Johann Behrens, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saal S, Becker C, Lorenz S, Schubert M, Kuss O, Stang A, Muller T, Kraft A, Behrens J. Effect of a stroke support service in Germany: a randomized trial. Top Stroke Rehabil. 2015 Dec;22(6):429-36. doi: 10.1179/1074935714Z.0000000047. Epub 2015 Apr 28.