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

February 12, 2024 updated by: Institut Investigacio Sanitaria Pere Virgili

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Tarragona
      • Tortosa, Tarragona, Spain, 43500
        • Silvia Reverté

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Calculated for two independent samples, variable SIS stroke impact scale result (DS 1.6). Accepting an alpha risk of 0.05 and a beta risk of less than 0.2 in a bilateral contrast, 35 subjects are needed in the first group and 35 in the second to detect a difference equal to or greater than 0.18 units. It is assumed that the common standard deviation is 0.25. A tracking loss rate has been estimated of 10%.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Impact Scale
Time Frame: 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].
At the beginning of the enrollment, 3, 6 ,12, 18 and 24 months later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Investigacio Sanitaria Pere Virgili

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

November 5, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC P18/071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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