Participative Rehabilitation in Stroke Patients

Phase 3

Completed

• Conditions: Stroke
• Interventions: Behavioral: Case management

• Registration Number: NCT00687869
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

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.

Study Timeline

• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-28
• Study Start: 2008-06
• Study First Posted: 2008-06-02
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-18
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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

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Exclusion Criteria

• Reinfarction
• Alcoholism
• Death in acute care
• NIHHS > 25
• Homelessness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case management	Case management	Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal
usual care	Case management	Usual stroke aftercare plus patient-information-notes

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale); 🇩🇪 Halle (Saale), Germany