Post-Stroke Disease Management - Stroke Card

NCT02156778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2149

Last updated 2019-04-09

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Cemit Center of Excellence in Medicine and IT

    collaborator OTHER
  • Tiroler Landeskrankenanstalten GmbH (TILAK)

    collaborator UNKNOWN
  • Tiroler Gebietskrankenkasse (TGKK)

    collaborator UNKNOWN
  • Tiroler Gesundheitsfonds (TGF)

    collaborator UNKNOWN
  • Private Universität für Gesundheitswissenschaften, Medizinische Informatik und Technik (UMIT)

    collaborator UNKNOWN
  • Barmherzige Brüder Vienna

    collaborator OTHER
  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Johann Willeit, MD · Department of Neurology, Medical University Innsbruck

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-03
Primary Completion
2019-01-15
Completion
2019-01-15

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02156778 on ClinicalTrials.gov