Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Participative Rehabilitation in Stroke Patients (PaReSiS)

This study has been completed.
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
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   (Adult, Senior)
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
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

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 
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:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2016