Patients after ischemic stroke are at high risk of recurrent cardiovascular events and of developing post-stroke complications. There is a substantial gap between risk factor management in real life and that recommended by international guidelines. Stroke Card is a multifaceted comprehensive post-stroke disease management program to detect and treat complications and optimize secondary prevention. The investigators hypothesize that, compared to standard care, Stroke Card will lead to an at least 33.3% risk reduction in recurrent cardiovascular events and improve health-related quality-of-life.

Post-Stroke Disease Management - Stroke Card

Stroke

Ischemic Attack, Transient

Secondary Prevention

Disease Management

Cost-Benefit Analysis

Stroke is the leading cause of disability and morbidity in the Western world and will extend its lead based on the continuous aging of European populations. Apart from persistent deficits, potentially avoidable medium- and long-term complications are significant contributors to post-stroke functional impairment and an appealing target for concerted interventions. Moreover, there is a substantial gap between risk factor management in real life and that recommended by international guidelines, resulting in a large number of avoidable recurring events.

Stroke Card is a prospective block-randomized open interventional trial with blinded outcome assessment comparing two standards of post-stroke patient care which both comply with the current state-of-the-art. Consecutive patients treated at the Department of Neurology of the University Hospital Innsbruck with ischemic stroke or high-risk TIA will be allocated to either standard care or extended standard care according to the Stroke Card concept and will be enrolled during the initial hospital stay. A second study center (Hospital St. John of God Vienna) is also enrolling patients. The program complies with the respective guidelines of the American Heart Association (AHA), focuses on patient empowerment, patient self-management education, routine reporting to the general practitioner (GP), evidence-based decision making, shared knowledge, and cooperation among physicians.

Whereas disease management programs typically rely on expert opinion, our initiative moves from a purely empirical approach to a highly structured, individualized and evidence-based procedure with an outcome and health economy analysis.

Generic objectives:

Early detection or prevention of post-stroke complications, estimation of the patient's demand for nursing services and support, guideline-conform secondary prevention with full achievement of target levels, lifestyle modifications and outcome assessment after 3 and 12 months, assessment of 12-Mo body functioning (impairment), activity (disability) and participation (handicap and quality-of-life (QoL)).

Detailed assessment of patient adherence to drug prescriptions as well as lifestyle modifications and analysis of its key determinants.

Implementation of a simple electronic tool for patients ("My Stroke Card") capable of storing data, displaying risk factor levels over time (graphs), giving feedback about target level achievement (red, orange, green), providing information (recommendations, self-administered patient training programmes, etc), and unraveling post-stroke complications (modified post-stroke checklist). The "My Stroke Card" is also available in print version for patients without personal computer (PC) access.

Scientific proof that extended standard care ameliorates functional outcome and patient wellbeing (QoL), and improves secondary prevention of stroke and other vascular sequels without raising costs.

Refinement of Stroke Card components in the case of success to end up with a condensed practicable approach for broad routine use, and identification of subgroups with the most pronounced benefit.

Active Comparator: Extended Standard Care (Stroke Card)

Active Comparator: Standard Care

Multifaceted Intervention to Reduce Recurrent Cardiovascular Events and Improve Quality-of-Life After Ischemic Stroke and High-Risk Transient Ischemic Attack (TIA)

A.Univ.-Prof.

modified Rankin Scale (mRS) ≤2 and shift analysis

Blood pressure < 140/90 (<130/85 in selected patients with diabetes, renal impairment or small-vessel disease), Hba1c<7.5% in patients with diabetes mellitus at baseline, nicotine abstinence in patients that had been smokers at baseline, LDL cholesterol < 100 mg/dL or <70 mg/dL in high-risk patients (i.e. stroke or TIA due to large-artery atherosclerosis or small-vessel occlusion, other evidence of atherosclerotic vascular disease, baseline diabetes), metabolic Syndrome (NCEP-ATPIII): reduction of component number by 1, physical activity >90 minutes, platelet inhibitor or oral anticoagulation, oral anticoagulation (INR 2-3, Time in Therapeutic Range (TTR)>70%) in case of atrial fibrillation (AF), lipid-lowering medication except for non-atherosclerotic strokes (e.g. vessel dissection).

Post-Stroke Disease Management - Stroke Card

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?