Participative Rehabilitation in Stroke Patients (PaReSiS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Saal S, Becker C, Lorenz S, Schubert M, Kuss O, Stang A, Müller 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.

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
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