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

NCT03732417 | Withdrawn

• 1 other identifier: CEIC P18/071
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Risk Factor, Cardiovascular

Keywords

Nurse's Role; quality of life; adherence; risk factors; stroke; secondary prevention

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

Interventions

Secondary prevention of cardiovascular risk factors OTHER

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

Telematic model treatment of patients with Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

Silvia Reverté

Tortosa, Tarragona, 43500, Spain

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: November 6, 2018
• Study Start: October 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 31, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)