Post-Stroke Disease Management - Stroke Card

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Medical University Innsbruck
Sponsor:
Collaborators:
Center of Excellence in Medicine and IT (CEMIT)
Tiroler Landeskrankenanstalten GmbH (TILAK)
Tiroler Gebietskrankenkasse (TGKK)
Tiroler Gesundheitsfonds (TGF)
Private Universität für Gesundheitswissenschaften, Medizinische Informatik und Technik (UMIT)
Information provided by (Responsible Party):
Stefan Kiechl, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT02156778
First received: June 3, 2014
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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 hypothesis that, compared to standard care, Stroke Card will lead to an at least 13.3% risk reduction in recurrent cardiovascular events and improve health-related quality-of-life.


Condition Intervention 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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

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


Secondary Outcome Measures:
  • Recurrent stroke (both ischemic and hemorrhagic) and TIA [ Time Frame: one year and up to three years ] [ Designated as safety issue: Yes ]
  • Death from all causes [ Time Frame: one year and up to three years ] [ Designated as safety issue: Yes ]
  • Functional outcome [ Time Frame: at one year and at three months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Target level achievement in secondary prevention [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2400
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)
Arms Assigned Interventions
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.


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. 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute ischemic stroke or high-risk TIA (ABCD2≥3 or visible diffusion-weighted imaging (DWI) lesion on MRI)
  • Age ≥ 18 years
  • Written informed consent

Exclusion Criteria:

  • Patients living outside Tyrol
  • 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02156778

Contacts
Contact: Stefan Kiechl, MD +43-512-504- ext 24244 stefan.kiechl@i-med.ac.at
Contact: Thomas Toell, MD +43-512-504- ext 82302 thomas.toell@i-med.ac.at

Locations
Austria
Department of Neurology, Medical University Innsbruck Recruiting
Innsbruck, Tyrol, Austria, 6020
Sub-Investigator: Thomas Töll, MD         
Sponsors and Collaborators
Medical University Innsbruck
Center of Excellence in Medicine and IT (CEMIT)
Tiroler Landeskrankenanstalten GmbH (TILAK)
Tiroler Gebietskrankenkasse (TGKK)
Tiroler Gesundheitsfonds (TGF)
Private Universität für Gesundheitswissenschaften, Medizinische Informatik und Technik (UMIT)
Investigators
Principal Investigator: Johann Willeit, MD Department of Neurology, Medical University Innsbruck
  More Information

Additional Information:
No publications provided

Responsible Party: Stefan Kiechl, A.Univ.-Prof., Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT02156778     History of Changes
Other Study ID Numbers: UN2013-0045, 20131203-854
Study First Received: June 3, 2014
Last Updated: June 4, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University Innsbruck:
Post-Stroke Disease Management
Post-Stroke Complication
Risk Factor Control
Quality-of-Life

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction

ClinicalTrials.gov processed this record on July 22, 2014