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Participative Rehabilitation in Stroke Patients (PaReSiS)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Case management
Case management
Sponsored by
Martin-Luther-Universität Halle-Wittenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring stroke, rehabilitation, patient care management, patient participation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Case management

usual care

Arm Description

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

Usual stroke aftercare plus patient-information-notes

Outcomes

Primary Outcome Measures

physical scale of the Stroke Impact Scale 3.0

Secondary Outcome Measures

Health related quality of life, depression, mortality, recurrent stroke and/or TIA/PRIND

Full Information

First Posted
May 28, 2008
Last Updated
September 18, 2013
Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt, Deutsche Rentenversicherung, Universitätsklinik und Poliklinik für Neurologie
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1. Study Identification

Unique Protocol Identification Number
NCT00687869
Brief Title
Participative Rehabilitation in Stroke Patients
Acronym
PaReSiS
Official Title
Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt"
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt, Deutsche Rentenversicherung, Universitätsklinik und Poliklinik für Neurologie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, rehabilitation, patient care management, patient participation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case management
Arm Type
Experimental
Arm Description
Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal
Arm Title
usual care
Arm Type
Active Comparator
Arm Description
Usual stroke aftercare plus patient-information-notes
Intervention Type
Behavioral
Intervention Name(s)
Case management
Intervention Description
Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal
Intervention Type
Behavioral
Intervention Name(s)
Case management
Intervention Description
Usual stroke aftercare plus patient-information-notes
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann Behrens, Prof. Dr.
Organizational Affiliation
Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)
City
Halle (Saale)
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25920942
Citation
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.
Results Reference
derived

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Participative Rehabilitation in Stroke Patients

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