CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,149 enrolled
Drug / intervention
Active Comparator: Extended Standard Care (Stroke Card) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT02156778
NCT02156778N/ACompleted

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

Medical University Innsbruck·interventional·Posted Jun 5, 2014·Updated Apr 9, 2019

In Brief

A clinical study evaluating Active Comparator: Extended Standard Care (Stroke Card) and Active Comparator: Standard Care for Stroke and 4 related conditions. Completed, enrolled 2,149 participants across 1 site.

Detailed Summary

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.

Study Details

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 5, 2014
Enrollment StartJan 3, 2014
Primary CompletionJan 15, 2019
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 12.1 years ago

Interventions

Active Comparator: Extended Standard Care (Stroke Card)behavioral

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 Carebehavioral

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). 12-Mo clinical visit and outcome assessment.