PaReSiS: Participative Rehabilitation in Stroke Patients

Sponsor

Martin-Luther-Universität Halle-Wittenberg (Other)

Overall Status

Completed

CT.gov ID

NCT00687869

Collaborator

Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt (Other), Deutsche Rentenversicherung (Other), Universitätsklinik und Poliklinik für Neurologie (Other)

322

Enrollment

Location

Arms

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: Case management Behavioral: Case management	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

322 participants

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"

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)