Clinical trial NCT02156778: Post-Stroke Disease Management - 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: Cemit Center of Excellence in Medicine and IT
name: Tiroler Landeskrankenanstalten GmbH (TILAK)
name: Tiroler Gebietskrankenkasse (TGKK)
name: Tiroler Gesundheitsfonds (TGF)
name: Private Universität für Gesundheitswissenschaften, Medizinische Informatik und Technik (UMIT)
name: Barmherzige Brüder Vienna
First posted: 2014-06-05
Enrollment: 2149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Major recurrent (post-discharge) cardiovascular events [nonfatal stroke, nonfatal myocardial infarction, and vascular death]
timeFrame: one year
measure: Health-related QoL (European Quality of Life-5 Dimensions EQ-5D-3L - overall health utility score)
timeFrame: at one year
Secondary outcomes:
measure: Recurrent stroke (both ischemic and hemorrhagic) and TIA
timeFrame: one year
measure: Death from all causes
timeFrame: one year
measure: Functional outcome
timeFrame: at one year
measure: Quality-of-Life 5 individual dimensions (mobility, self-care, usual activities, pain and discomfort, anxiety and depression)
timeFrame: at one year
measure: Target level achievement in secondary prevention
timeFrame: at one year
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Neurology, Medical University Innsbruck
state: Tyrol
Study officials:
affiliation: Department of Neurology, Medical University Innsbruck
name: Johann Willeit, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.