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

Primary Purpose

Stroke, Ischemic Attack, Transient, Secondary Prevention

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Active Comparator: Extended Standard Care (Stroke Card)
Active Comparator: Standard Care
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Post-Stroke Disease Management, Post-Stroke Complication, Risk Factor Control, Quality-of-Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Neurology, Medical University Innsbruck

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Extended Standard Care (Stroke Card)

Standard Care

Arm Description

Outcomes

Primary Outcome Measures

Major recurrent (post-discharge) cardiovascular events [nonfatal stroke, nonfatal myocardial infarction, and vascular death]
Health-related QoL (European Quality of Life-5 Dimensions EQ-5D-3L - overall health utility score)
Co-primary endpoint

Secondary Outcome Measures

Recurrent stroke (both ischemic and hemorrhagic) and TIA
Death from all causes
Functional outcome
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)
Target level achievement in secondary prevention
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).

Full Information

First Posted
June 3, 2014
Last Updated
April 5, 2019
Sponsor
Medical University Innsbruck
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), Barmherzige Brüder Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02156778
Brief Title
Post-Stroke Disease Management - Stroke Card
Acronym
Stroke Card
Official Title
Multifaceted Intervention to Reduce Recurrent Cardiovascular Events and Improve Quality-of-Life After Ischemic Stroke and High-Risk Transient Ischemic Attack (TIA)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2014 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University Innsbruck
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), Barmherzige Brüder Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic Attack, Transient, Secondary Prevention, Disease Management, Cost-Benefit Analysis
Keywords
Post-Stroke Disease Management, Post-Stroke Complication, Risk Factor Control, Quality-of-Life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended Standard Care (Stroke Card)
Arm Type
Active Comparator
Arm Title
Standard Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Active Comparator: Extended Standard Care (Stroke Card)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Comparator: Standard Care
Intervention Description
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 Measure Information:
Title
Major recurrent (post-discharge) cardiovascular events [nonfatal stroke, nonfatal myocardial infarction, and vascular death]
Time Frame
one year
Title
Health-related QoL (European Quality of Life-5 Dimensions EQ-5D-3L - overall health utility score)
Description
Co-primary endpoint
Time Frame
at one year
Secondary Outcome Measure Information:
Title
Recurrent stroke (both ischemic and hemorrhagic) and TIA
Time Frame
one year
Title
Death from all causes
Time Frame
one year
Title
Functional outcome
Description
modified Rankin Scale (mRS) ≤2 and shift analysis
Time Frame
at one year
Title
Quality-of-Life 5 individual dimensions (mobility, self-care, usual activities, pain and discomfort, anxiety and depression)
Time Frame
at one year
Title
Target level achievement in secondary prevention
Description
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).
Time Frame
at one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann Willeit, MD
Organizational Affiliation
Department of Neurology, Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Medical University Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32954239
Citation
Willeit P, Toell T, Boehme C, Krebs S, Mayer L, Lang C, Seekircher L, Tschiderer L, Willeit K, Rumpold G, Schoenherr G, Griesmacher A, Ferrari J, Knoflach M, Lang W, Kiechl S, Willeit J; STROKE-CARD study group. STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial. EClinicalMedicine. 2020 Jul 28;25:100476. doi: 10.1016/j.eclinm.2020.100476. eCollection 2020 Aug.
Results Reference
derived

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Post-Stroke Disease Management - Stroke Card

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