Telematic Model Integrated in the Transversal Care of the Secondary Prevention of Patients With Stroke

Stroke Clinical Trial

Official title:

Effectiveness of a Telematic Model Integrated in the Transversal Care of the Secondary Prevention of Patients With Stroke

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03732417
• Other study ID #: CEIC P18/071
• Status: Withdrawn
• Start date: October 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Institut Investigacio Sanitaria Pere Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In Spain, stroke is the leading cause of death in women and disability in adults, which is why it is currently one of the most important public health problems. It is known that the main cause of stroke is the lack of control of cardiovascular risk factors (CRF). Strategies have been diversified for patients with severe neurological involvement, while those without or with mild involvement, susceptible to repeat a stroke, have a very heterogeneous approach.

Objective: Design, implement and evaluate the effectiveness of the transversal telematic model of secondary prevention in patients who have suffered a stroke.

Methodology: Randomized clinical trial with a control group, open and multicentre. A total of 70 patients (35 per group) will be included who meet all the inclusion criteria and none of exclusion, attended by an acute stroke in the Hospital Verge de la Cinta de Tortosa. Variables: sociodemographic and clinical, FRC, stage of change, therapeutic compliance and CV. Outcome variables: impact of the stroke using the scale (SIS-16); control of CRF, new vascular events and mortality at 3, 6, 12, 18 and 24 months, integrable in the practice and computerized clinical history (HCI). Interventions: control and education for the patient's health to promote self-care and empowerment, and enhance pharmacological compliance. The telematic model has been developed through clinical practice guides of primary care and the most recent publications on the subject referenced. Export of data directly from the HCI.

Analysis of results with the SPSS 23.0 program, using regression and survival models.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients =18 years old, diagnosed of established ischemic stroke and / or TIA and attended by the HTVC neurology service, on discharge from home and with habitual residence in the Ebro Lands to be able to follow up .

• Informed consent of the signed study.

Exclusion Criteria:

• Patients suffering from other neurological injuries that interfere with the follow-up (established strokes, with or without MCA deviation, glioblastomas, etc.), life expectancy <6 months, modified Rankin scale score (MRS) =3 and present language barrier and / or aphasia.

Related Conditions & MeSH terms

• Risk Factor, Cardiovascular
• Stroke

Intervention

Other:
• Secondary prevention of cardiovascular risk factors
Intervention group (n=35) Control group (n=35)

Locations

Country	Name	City	State
Spain	Silvia Reverté	Tortosa	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Investigacio Sanitaria Pere Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke Impact Scale	Change from Baseline The Stroke Impact Scale for disability at 3, 6, 12, 18 and 24 months. Score range [16-80].	At the beginning of the enrollment, 3, 6 ,12, 18 and 24 months later.