Participative Rehabilitation in Stroke Patients (PaReSiS)
This study has been completed.
Sponsor:
Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00687869
First Posted: June 2, 2008
Last Update Posted: September 19, 2013
Collaborators:
Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt
Deutsche Rentenversicherung
Universitätsklinik und Poliklinik für Neurologie
Information provided by (Responsible Party):
Johann Behrens, Martin-Luther-Universität Halle-Wittenberg
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt" |
Resource links provided by NLM:
Further study details as provided by Johann Behrens, 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 ]
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 ]
| 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
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| First Submitted: | May 28, 2008 |
| 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 |