Participative Rehabilitation in Stroke Patients (PaReSiS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Martin-Luther-Universität Halle-Wittenberg.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Martin-Luther-Universität Halle-Wittenberg
Collaborators:
German Federal Ministry of Education and Research
Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt
Deutsche Rentenversicherung Mitteldeutschland
Universitätsklinik und Poliklinik für Neurologie
Information provided by:
Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00687869
First received: May 28, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
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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:
Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:
Primary Outcome Measures:
- Physical and cognitive capacity using the Functional Independence Measure (FIM) [ Time Frame: at 1 year after discharge ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Health related quality of life, depression, mortality, recurrent stroke and/or TIA/PRIND [ Time Frame: three days before discharge home - one year after intervention begins ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 310 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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: 2 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687869
Contacts
| Contact: Johann Behrens, Prof. Dr. | 49-0345-557-4450 |
Locations
| Germany | |
| Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale) | Not yet recruiting |
| Halle (Saale), Germany | |
| Contact: Johann Behrens, Prof. Dr. | |
| Principal Investigator: Johann Behrens, Prof. Dr. | |
| Sub-Investigator: Susanne Saal | |
| Sub-Investigator: Barbara Schubert | |
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
German Federal Ministry of Education and Research
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: | Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale) |
| ClinicalTrials.gov Identifier: | NCT00687869 History of Changes |
| Other Study ID Numbers: | 01GX0711 |
| Study First Received: | May 28, 2008 |
| Last Updated: | May 28, 2008 |
| 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 Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 23, 2013