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Participative Rehabilitation in Stroke Patients (PaReSiS)

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ClinicalTrials.gov Identifier: NCT00687869
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : September 19, 2013
Sponsor:
Collaborators:
Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt
Deutsche Rentenversicherung
Universitätsklinik und Poliklinik für Neurologie
Information provided by (Responsible Party):
Johann Behrens, Martin-Luther-Universität Halle-Wittenberg

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Case management Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt"
Study Start Date : June 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Case management
Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal
 Behavioral: Case management
Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal
Active Comparator: usual care
Usual stroke aftercare plus patient-information-notes
 Behavioral: Case management
Usual stroke aftercare plus patient-information-notes


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Health related quality of life, depression, mortality, recurrent stroke and/or TIA/PRIND [ 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687869


Locations
Germany
Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)
Halle (Saale), Germany
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt
Deutsche Rentenversicherung
Universitätsklinik und Poliklinik für Neurologie
Investigators
Principal Investigator: Johann Behrens, Prof. Dr. Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johann Behrens, Prof. Dr. phil. habil., Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00687869     History of Changes
Other Study ID Numbers: 01GX0711
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013

Keywords provided by Johann Behrens, Martin-Luther-Universität Halle-Wittenberg:
stroke
rehabilitation
patient care management
patient participation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases