NCT04524078

Lleida TIA Intervention Study

Integrated Care Improves Risk-factor Modification After Transient Ischemic Attack or Minor Stroke Patients (Lleida TIA Intervention Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Institut de Recerca Biomèdica de Lleida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Having a transient ischemic attack (TIA) or a minor stroke is a real risk factor not only for early recurrent stroke but also for major extracranial vascular events. Despite these warning events provide an opportunity for prevention usual post-discharge care of these subjects (mainly at primary care) is not associated with an optimal control of cerebrovascular risk factors (CRF). The investigators hypothesized that patients exposed to the intensified integrated multifactorial interventional care program (ICP) model would exhibit better management of CRF and receive more targeted advice than patients receiving standard care. A second objective was to investigate the effect of the ICP model on stroke recurrence or the appearance of major extracranial vascular events. To test this hypothesis the investigators perform a controlled, randomized, single blind, parallel trial. Subjects are recruited at the Stroke Unit and are randomized into two groups: 1. usual care (control group) and 2. ICP (intervention group). Patients assigned to receive usual care (general practitioner with the possibility of being referred to specialists) are compared to those assigned to undergo ICP. This ICP involves strict treatment goals (LDL-cholesterol \<100 mg/dl, blood pressure \<130/80 mmHg, HbA1c\<7%, no smoking, regular exercise and no excessive alcohol consumption) to be achieved through behavior modification (diet, physical activity, smoking cessation, alcohol cessation) and a stepwise introduction of pharmacologic therapy for the main CRF (hypercholesterolemia, hypertension and diabetes). This multifactorial intervention is overseen in each primary care center by a trained general practitioner and nursery. The treatment goals are the same for the control group and the intervention group. General practitioners caring patients of each group are informed of these strict treatment goals. Patients in the ICP group receive a minimum of four scheduled individual consultations in one year (baseline, 3, 6 and 9 months). Primary and secondary outcomes are evaluated by an external Neurologist at 12 months after their inclusion.

Conditions

• Transient Ischemic Attack

Interventions

Type	Name	Description
OTHER	intensive integrated intervention care program	intensive integrated intervention care program \[ICP\] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events

Timeline

• Start date: 2011-03-01
• Primary completion: 2020-03-01
• Completion: 2020-03-31
• First posted: 2020-08-24
• Last updated: 2020-08-24