The Care of Stroke in the Hospital of Genk: Outcome After Treatment and the Health-economic Impact of Stroke in the Patient Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 564
- Locations
- 1
- Primary Endpoint
- Modified rankin scale
Study Overview
Brief Summary
A stroke occurs when the blood circulation is hampered due an ischemic or hemorrhagic event. Previous, a stroke was treated only with anti-aggregation. Over time, multiple studies have showed a positive effect of intravenous thrombolysis with rt-PA (recombinant tissue plasminogen activator) in comparison with the standard treatment (anti-aggregation). Since 2015, thrombectomy was proven to have an added value in combination with thrombolysis. Thrombectomy is an endovascular technique where the thrombus is removed or fragmented.
Diagnosis and treatment of stroke will have a significant impact on the health-economic status of the patient. However, little data is known. Unfortunately, the outcome after diagnosis with a stroke is not well documented. Therefore, this follow-up study over a time period of one year, will give us a sufficient amount of data to evaluate patients diagnosed with a stroke in the hospital of Genk.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •signed informed consent
- •older than 18 years
- •diagnosed with stroke
Exclusion Criteria
- •younger than 18 years
Outcomes
Primary Outcomes
Modified rankin scale
Time Frame: day 1, 3 months and 12 months
Change in modified rankin scale over time: baseline (diagnosis stroke), 3 months and one year follow-up. Modified rankin scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.
Secondary Outcomes
- Rehabilitation: evaluation muscle strength(day 1, 3 months and 12 months)
- Rehabilitation: evaluation arm/hand function(day 1, 3 months and 12 months)
- Quality of life-EQ5D(day 1, 3 months and 12 months)
- National Institutes of Health Stroke Scale (NIHSS)(day 1, 3 months and 12 months)
- Quality of life-Barthel index(day 1, 3 months and 12 months)
- Quality of life-stroke specific quality of life scale(day 1, 3 months and 12 months)
- Rehabilitation: walking capability(day 1, 3 months and 12 months)
- Rehabilitation: trunk control test(day 1, 3 months and 12 months)
Investigators
Dieter Mesotten
MD
Ziekenhuis Oost-Limburg