Post-Stroke Disease Management - Stroke Card (Stroke Card)
|Stroke Ischemic Attack, Transient Secondary Prevention Disease Management Cost-Benefit Analysis||Behavioral: Active Comparator: Extended Standard Care (Stroke Card) Behavioral: Active Comparator: Standard Care||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Phase 3 Study of Multifaceted Intervention to Reduce Recurrent Cardiovascular Events and Improve Quality-of-Life After Ischemic Stroke and High-Risk Transient Ischemic Attack (TIA)|
- Major recurrent (post-discharge) cardiovascular events [nonfatal stroke, nonfatal myocardial infarction, and vascular death] [ Time Frame: one year ]
- Health-related QoL (European Quality of Life-5 Dimensions EQ-5D-3L - overall health utility score) [ Time Frame: at one year ]Co-primary endpoint
- Recurrent stroke (both ischemic and hemorrhagic) and TIA [ Time Frame: one year and up to three years ]
- Death from all causes [ Time Frame: one year and up to three years ]
- Functional outcome [ Time Frame: at one year and at three months ]modified Rankin Scale (mRS) ≤2 and shift analysis
- Quality-of-Life 5 individual dimensions (mobility, self-care, usual activities, pain and discomfort, anxiety and depression) [ Time Frame: at one year ]
- Target level achievement in secondary prevention [ Time Frame: at one year ]Blood pressure < 140/90 (<130/85 in selected patients with diabetes, renal impairment or small-vessel disease) in > 85% of self-assessments, Hba1c<7.5%, nicotine abstinence, LDL cholesterol < 100 mg/dL or 70 mg/dL in high-risk patients (intra- or extracranial vessel stenosis, instable plaques, atherothrombotic strokes), metabolic Syndrome (NCEP-ATPIII): reduction of component number by 1, physical activity > 30 minutes at least 3 times per week, platelet inhibitor or anticoagulation, oral anticoagulation (INR 2-3, Time in Therapeutic Range (TTR)>70%) in case of atrial fibrillation (AF), statins except for non-atherosclerotic strokes (e.g. vessel dissection), compliance to drug prescription >90%
- Cost-effectiveness [ Time Frame: one year ]Cost-utility analysis (costs assessed in monetary units) and benefit measured as a non-monetary utility-adjusted outcome (quality-adjusted life-year (QALY))
- Number of out-of-schedule consultations of physicians and out-patient hospital services, and out-of-schedule hospital admissions [ Time Frame: one year ]
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
|Active Comparator: Extended Standard Care (Stroke Card)||
Behavioral: Active Comparator: Extended Standard Care (Stroke Card)
Standard Care plus
extended training with access to weekly educational lectures (education of patients and relatives), implementation of "My Stroke Card" containing (a) an adopted version of the 'post-stroke checklist' (ascertainment of post-stroke complications), (b) self-administered internet-based tools for risk factor monitoring and reinforcement of target level achievement, and (c) information and educational materials.
3-Mo outpatient appointment with standardized assessment of risk factors and screening for complications, health problems and residual deficits, estimation of the patient's demand for nursing services and support, guideline-conform secondary prevention with full achievement of target levels, assessment of patient adherence to drug prescriptions.
6-Mo and 9-Mo visits on the discretion of the study team in case of medical needs.
12-Mo clinical visit and outcome assessment.
|Active Comparator: Standard Care||
Behavioral: Active Comparator: Standard Care
In-hospital training (education of patients, next of kin and caregivers on risk factor management and assessment, life style improvement, and compliance).
Complimentary provision of a book / information material dealing with patient and caregiver relevant aspects of stroke care.
Advise by a dietitian (general advise and individualized recommendations in patients with diabetes and obesity).
Standardized information materials (e.g. for OAK or NOAK therapy). Support for smoking cessation and weight reduction if necessary or requested. Detailed medical reports (doctor's letter for the general practitioner and patient) at discharge containing target levels for risk factor management.
AF detection at the Stroke Unit (1-5 day monitoring) and/or at the ward (24-hour ECG).
3-Mo telephone interview and 12-Mo clinical visit and outcome assessment.
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. Recruitment of patients in two further Austrian stroke centers is intended. 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 a outcome and health economy analysis.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02156778
|Contact: Stefan Kiechl, MD||+43-512-504- ext email@example.com|
|Contact: Thomas Toell, MD||+43-512-504- ext firstname.lastname@example.org|
|Department of Neurology, Medical University Innsbruck||Recruiting|
|Innsbruck, Tyrol, Austria, 6020|
|Sub-Investigator: Thomas Töll, MD|
|Principal Investigator:||Johann Willeit, MD||Department of Neurology, Medical University Innsbruck|