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Participative Rehabilitation in Stroke Patients

NCT ID: NCT00687869

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Stroke

Keywords

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stroke rehabilitation patient care management patient participation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Case management

Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal

Group Type EXPERIMENTAL

Case management

Intervention Type BEHAVIORAL

Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal

usual care

Usual stroke aftercare plus patient-information-notes

Group Type ACTIVE_COMPARATOR

Case management

Intervention Type BEHAVIORAL

Usual stroke aftercare plus patient-information-notes

Interventions

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Case management

Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal

Intervention Type BEHAVIORAL

Case management

Usual stroke aftercare plus patient-information-notes

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt

UNKNOWN

Sponsor Role collaborator

Deutsche Rentenversicherung

OTHER

Sponsor Role collaborator

Universitätsklinik und Poliklinik für Neurologie

UNKNOWN

Sponsor Role collaborator

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role lead

Responsible Party

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Johann Behrens

Prof. Dr. phil. habil.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johann Behrens, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)

Locations

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Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)

Halle, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 25920942 (View on PubMed)

Other Identifiers

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01GX0711

Identifier Type: -

Identifier Source: org_study_id