StrokeNCT03732417
Telematic Model Integrated in the Transversal Care of the Secondary Prevention of Patients With Stroke
An observational study of Stroke and Risk Factor, Cardiovascular, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Risk Factor, Cardiovascular
- What is being tested?
- Secondary prevention of cardiovascular risk factors
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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%.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Secondary prevention of cardiovascular risk factors
- Keywords
- Nurse's Role, quality of life, adherence, risk factors, stroke, secondary prevention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary prevention of cardiovascular risk factorsOther
Intervention group (n=35) Control group (n=35)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Secondary prevention of cardiovascular risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Impact Scale
Change from Baseline The Stroke Impact Scale for disability at 3, 6, 12, 18 and 24 months. Score range [16-80].
Measured: At the beginning of the enrollment, 3, 6 ,12, 18 and 24 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Oct 2021
- Primary completion1 Oct 2021
- Study completion31 Dec 2023
Why it stopped: The start of the study was temporarily interrupted due to the COVID-19 pandemic. Subsequently, it was not feasible to initiate the study due to changes in the healthcare system for patient follow-up. For this reason, the study was withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732417
- Sponsor's protocol ID
- CEIC P18/071
- Status last verified
- Feb 2024
- First submitted
- 5 Oct 2018
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Telematic Model Integrated in the Transversal Care of the Secondary Prevention of Patients With Stroke
- ClinicalTrials.gov ID
- NCT03732417
- Acronym / sponsor ID
- CEIC P18/071
- Conditions
- Stroke, Risk Factor, Cardiovascular
- Keywords
- Nurse's Role, quality of life, adherence, risk factors, stroke, secondary prevention
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The start of the study was temporarily interrupted due to the COVID-19 pandemic. Subsequently, it was not feasible to initiate the study due to changes in the healthcare system for patient follow-up. For this reason, the study was withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | –Control group included people with ischemic or haemorragic stroke in Terres de l'Ebre, Spain. |
| Telematic model treatment of patients with Stroke | – | Other: Secondary prevention of cardiovascular risk factorsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secondary prevention of cardiovascular risk factorsIntervention group (n=35) Control group (n=35) | Other | Telematic model treatment of patients with Stroke |
Primary outcome
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].
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Risk Factor, Cardiovascular, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Impact Scale (time frame: At the beginning of the enrollment, 3, 6 ,12, 18 and 24 months later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.