Post-Stroke Disease Management - Stroke Card

NCT02156778 | Completed

• 2 other identifiers: UN2013-004520131203-854
• Study Type: interventional
• Target: 2,149
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Major recurrent (post-discharge) cardiovascular events [nonfatal stroke, nonfatal myocardial infarction, and vascular death]

  one year

• Health-related QoL (European Quality of Life-5 Dimensions EQ-5D-3L - overall health utility score)

  Co-primary endpoint

  at one year

Secondary Outcomes (5)

• Recurrent stroke (both ischemic and hemorrhagic) and TIA

  one year

• Death from all causes

  one year

• Functional outcome

  at one year

• Quality-of-Life 5 individual dimensions (mobility, self-care, usual activities, pain and discomfort, anxiety and depression)

  at one year

• Target level achievement in secondary prevention

  at one year

Study Arms (2)

Extended Standard Care (Stroke Card)

ACTIVE COMPARATOR

Behavioral: Active Comparator: Extended Standard Care (Stroke Card)

Standard Care

ACTIVE COMPARATOR

Behavioral: Active Comparator: Standard Care

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.

Extended Standard Care (Stroke Card)

Active Comparator: Standard Care BEHAVIORAL

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Cemit Center of Excellence in Medicine and IT: collaborator
• Tiroler Landeskrankenanstalten GmbH (TILAK): collaborator
• Tiroler Gebietskrankenkasse (TGKK): collaborator
• Tiroler Gesundheitsfonds (TGF): collaborator
• Private Universität für Gesundheitswissenschaften, Medizinische Informatik und Technik (UMIT): collaborator
• Barmherzige Brüder Vienna: collaborator

Study Sites (1)

Department of Neurology, Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (4)

• Karisik A, Dejakum B, Moelgg K, Granna J, Felicetti S, Pechlaner R, Mayer-Suess L, Toell T, Buergi L, Scherer L, Willeit K, Heidinger M, Lang C, Ferrari J, Krebs S, Kleyhons R, Resch H, Willeit J, Seekircher L, Tschiderer L, Willeit P, Sykora M, Schett G, Lang W, Knoflach M, Kiechl S, Boehme C. Incidence, characteristics, and consequences of fractures after acute ischemic stroke and TIA-A prospective cohort study. Int J Stroke. 2025 Oct;20(9):1141-1149. doi: 10.1177/17474930251345300. Epub 2025 May 20.

  PMID: 40391684 DERIVED

• Karisik A, Bader V, Moelgg K, Buergi L, Dejakum B, Komarek S, Eller MT, Toell T, Mayer-Suess L, Pechlaner R, Granna J, Sollereder S, Rossi S, Schoenherr G, Willeit J, Willeit P, Lang W, Kiechl S, Knoflach M, Boehme C; STROKE-CARD study group. Comorbidities associated with dysphagia after acute ischemic stroke. BMC Neurol. 2024 Sep 28;24(1):358. doi: 10.1186/s12883-024-03863-1.

  PMID: 39342159 DERIVED

• 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.

  PMID: 32954239 DERIVED

• Toell T, Boehme C, Mayer L, Krebs S, Lang C, Willeit K, Prantl B, Knoflach M, Rumpold G, Schoenherr G, Griesmacher A, Willeit P, Ferrari J, Lang W, Kiechl S, Willeit J. Pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascular risk and improve quality-of-life after ischaemic stroke and transient ischaemic attack -study protocol. BMC Neurol. 2018 Nov 6;18(1):187. doi: 10.1186/s12883-018-1185-2.

  PMID: 30400876 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Johann Willeit, MD

  Department of Neurology, Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A.Univ.-Prof.

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 5, 2014
• Study Start: January 3, 2014
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

AU (1)