Participative Rehabilitation in Stroke Patients (PaReSiS)

This study has been completed.

Sponsor:

Collaborators:

Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt

Deutsche Rentenversicherung Mitteldeutschland

Universitätsklinik und Poliklinik für Neurologie

Information provided by (Responsible Party):

Johann Behrens, Martin-Luther-Universität Halle-Wittenberg

ClinicalTrials.gov Identifier:

NCT00687869

First received: May 28, 2008

Last updated: September 18, 2013

Last verified: September 2013

History of Changes

Purpose

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	Intervention	Phase
Stroke	Behavioral: Case management	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research
Official Title:	Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt"

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	322
Study Start Date:	June 2008
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Mitteldeutschland

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

No publications provided


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
Study First Received:	May 28, 2008
Last Updated:	September 18, 2013
Health Authority:	Germany: Federal Ministry of Education and Research

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:


stroke rehabilitation patient care management patient participation

Additional relevant MeSH terms:


Cerebral Infarction Stroke Brain Diseases Brain Infarction Brain Ischemia	Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 26, 2015

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