Participative Rehabilitation in Stroke Patients

Stroke Clinical Trial

— PaReSiS  

Official title:

Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687869
• Other study ID #: 01GX0711
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2008
• Last updated: September 18, 2013
• Start date: June 2008
• Est. completion date: March 2012

Study information

• Verified date: September 2013
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Case management
Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal
• Case management
Usual stroke aftercare plus patient-information-notes

Locations

Country	Name	City	State
Germany	Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)	Halle (Saale)

Sponsors (4)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	Deutsche Rentenversicherung, Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt, Universitätsklinik und Poliklinik für Neurologie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical scale of the Stroke Impact Scale 3.0		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	No
Secondary	Health related quality of life, depression, mortality, recurrent stroke and/or TIA/PRIND		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	No