Clinical trial NCT03732417: Telematic Model Integrated in the Transversal Care of the Secondary Prevention of Patients With Stroke
Official title: Effectiveness of a Telematic Model Integrated in the Transversal Care of the Secondary Prevention of Patients With Stroke
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke
Risk Factor, Cardiovascular
Keywords: Nurse's Role
quality of life
adherence
risk factors
stroke
secondary prevention
Lead sponsor: Institut Investigacio Sanitaria Pere Virgili
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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%.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Stroke Impact Scale
timeFrame: At the beginning of the enrollment, 3, 6 ,12, 18 and 24 months later.
Secondary outcomes:
Other outcomes:
Locations:
city: Tortosa
country: Spain
facility: Silvia Reverté
state: Tarragona
Study officials:
References: