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Clinical Trials/NCT00687869
NCT00687869
Completed
Phase 3

Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt"

Martin-Luther-Universität Halle-Wittenberg1 site in 1 country322 target enrollmentJune 2008
ConditionsStroke

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Stroke
Sponsor
Martin-Luther-Universität Halle-Wittenberg
Enrollment
322
Locations
1
Primary Endpoint
physical scale of the Stroke Impact Scale 3.0
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
March 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Johann Behrens

Prof. Dr. phil. habil.

Martin-Luther-Universität Halle-Wittenberg

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

Outcomes

Primary Outcomes

physical scale of the Stroke Impact Scale 3.0

Time Frame: 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

  • Health related quality of life, depression, mortality, recurrent stroke and/or TIA/PRIND(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)

Study Sites (1)

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