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

Sponsor

Institut Investigacio Sanitaria Pere Virgili (Other)

Overall Status

Suspended

CT.gov ID

NCT03732417

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Risk Factor, Cardiovascular	Other: Secondary prevention of cardiovascular risk factors

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Actual Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Stroke patients Control group included people with ischemic or haemorragic stroke in Terres de l'Ebre, Spain.
Telematic model treatment of patients with Stroke The intervention group included 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.	Other: Secondary prevention of cardiovascular risk factors Intervention group (n=35) Control group (n=35)

Arm

Intervention/Treatment

Stroke patients

Control group included people with ischemic or haemorragic stroke in Terres de l'Ebre, Spain.

Telematic model treatment of patients with Stroke

The intervention group included 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.

Other: Secondary prevention of cardiovascular risk factors

Intervention group (n=35) Control group (n=35)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.