Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-Stroke Disease Management - Stroke Card (Stroke Card)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02156778
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
Cemit Center of Excellence in Medicine and IT
Tiroler Landeskrankenanstalten GmbH (TILAK)
Tiroler Gebietskrankenkasse (TGKK)
Tiroler Gesundheitsfonds (TGF)
Private Universität für Gesundheitswissenschaften, Medizinische Informatik und Technik (UMIT)
Krankenhaus der Barmherzigen Brüder Wien
Information provided by (Responsible Party):
Stefan Kiechl, Medical University Innsbruck

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Ischemic Attack, Transient Secondary Prevention Disease Management Cost-Benefit Analysis Behavioral: Active Comparator: Extended Standard Care (Stroke Card) Behavioral: Active Comparator: Standard Care Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multifaceted Intervention to Reduce Recurrent Cardiovascular Events and Improve Quality-of-Life After Ischemic Stroke and High-Risk Transient Ischemic Attack (TIA)
Actual Study Start Date : January 3, 2014
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : January 15, 2019

Arm Intervention/treatment
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).

12-Mo clinical visit and outcome assessment.





Primary Outcome Measures :
  1. Major recurrent (post-discharge) cardiovascular events [nonfatal stroke, nonfatal myocardial infarction, and vascular death] [ Time Frame: one year ]
  2. Health-related QoL (European Quality of Life-5 Dimensions EQ-5D-3L - overall health utility score) [ Time Frame: at one year ]
    Co-primary endpoint


Secondary Outcome Measures :
  1. Recurrent stroke (both ischemic and hemorrhagic) and TIA [ Time Frame: one year ]
  2. Death from all causes [ Time Frame: one year ]
  3. Functional outcome [ Time Frame: at one year ]
    modified Rankin Scale (mRS) ≤2 and shift analysis

  4. Quality-of-Life 5 individual dimensions (mobility, self-care, usual activities, pain and discomfort, anxiety and depression) [ Time Frame: at one year ]
  5. 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), 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute ischemic stroke or high-risk TIA (ABCD2≥3)
  • Age ≥ 18 years
  • Written informed consent

Exclusion Criteria:

  • Patients living outside the hospital catchment area
  • Malignant or other severe disease with life-expectancy less than the expected duration of the trial
  • Drug addiction or severe alcohol abuse
  • Patients with persistent severe disability ad discharge (mRS=5) not suitable for rehabilitation (this group will have outcome and complication assessment by a telephone interview with the caregivers according to current standards)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156778


Locations
Layout table for location information
Austria
Department of Neurology, Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Cemit Center of Excellence in Medicine and IT
Tiroler Landeskrankenanstalten GmbH (TILAK)
Tiroler Gebietskrankenkasse (TGKK)
Tiroler Gesundheitsfonds (TGF)
Private Universität für Gesundheitswissenschaften, Medizinische Informatik und Technik (UMIT)
Krankenhaus der Barmherzigen Brüder Wien
Investigators
Layout table for investigator information
Principal Investigator: Johann Willeit, MD Department of Neurology, Medical University Innsbruck
  Study Documents (Full-Text)

Documents provided by Stefan Kiechl, Medical University Innsbruck:
Statistical Analysis Plan  [PDF] February 1, 2019


Layout table for additonal information
Responsible Party: Stefan Kiechl, A.Univ.-Prof., Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT02156778    
Other Study ID Numbers: UN2013-0045
20131203-854 ( Other Identifier: Clinical Trial Center TILAK / MUI )
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Stefan Kiechl, Medical University Innsbruck:
Post-Stroke Disease Management
Post-Stroke Complication
Risk Factor Control
Quality-of-Life
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia