Participative Rehabilitation in Stroke Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Participative Rehabilitation Process Management Stroke in Saxony-Anhalt

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Case management
* Behavioral: Case management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case management<br>Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal | Behavioral: Case management<br>* Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal<br>|
| Active Comparator: usual care<br>Usual stroke aftercare plus patient-information-notes | Behavioral: Case management<br>* Usual stroke aftercare plus patient-information-notes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, rehabilitation, patient care management, patient participation