Ischemia StrokeNCT07343284
Nursing Health Education to Improve Functionality and Quality of Life After Ischemic Stroke
A study testing Health education Program in people with Ischemia Stroke and Post-stroke Depression, run by University of Santiago de Compostela.
Trial summary
This study is titled "Effect of a Nursing Intervention Based on Health Education on Functionality, Depression Symptoms, and Quality of Life in Patients with Ischemic Stroke." It is a quasi-experimental, longitudinal, prospective clinical trial that will beconducted with patients who have suffered an ischemic stroke… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia Stroke, Post-stroke Depression, Post-stroke
- What is being tested?
- Health education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Anterior or posterior cerebral occlusion
Who cannot join
- Intracranial hemorrhage
- Pregnancy
- Cognitive incapacity for participation
- Refusal to participate in the study and administer the questionnaires.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of a Nursing Intervention Based on Health Education on Functionality, Depression Symptoms, and Quality of Life in Patients With Ischemic Stroke: A Quasi-Experimental, Longitudinal, and Prospective Clinical Trial
This study is titled "Effect of a Nursing Intervention Based on Health Education on Functionality, Depression Symptoms, and Quality of Life in Patients with Ischemic Stroke." It is a quasi-experimental, longitudinal, prospective clinical trial that will beconducted with patients who have suffered an ischemic stroke and were treated in the neurology unit of the Lucus Augusti University Hospital, the same center where this study will take place.
The primary objective of the study is to determine the effect of a nursing intervention based on health education on quality of life and depression symptoms in individuals who have experienced an ischemic stroke.
Read more
To achieve this objective, variables such as cognitive status, depression symptoms, autonomy and ability to perform basic activities of daily living, neurological deficits, and quality of life will be assessed.
Regarding the total number of subjects to be studied, according to the Stroke Atlas in Galicia published by the Spanish Society of Neurology in 2018, the autonomous community of Galicia had a population of 2,701,819 inhabitants. Applying an incidence rate of 187.4 cases per 100,000 inhabitants according to the IBERICTUS study, an estimated 5,064 new stroke cases occur each year in Galicia. The province of Lugo had 324,842 inhabitants as of January 1, 2024, according to the INE; therefore, applying the same incidence rate, an estimated 609 new stroke cases occur per year. Considering the proportion of ischemic strokes compared to other types of strokes (80:20), the estimated number of ischemic stroke cases in Lugo would be 487. The representative sample size of stroke patients in the province of Lugo would be 70 patients, with 35 patients receiving the intervention and 35 serving as controls.
Independent Variables:
Sociodemographic: sex, age, event date. Clinical: stroke type, treatment modality (rt-PA or thrombectomy), falls, pain, pressure ulcers, aspiration, pneumonia, dysphagia, vital signs.
Health education: received vs. not received.
Dependent Variables:
Cognitive status (MMSE). Depression symptoms (BDI). Autonomy and ADL performance (Barthel Index). Neurological deficits (NIHSS). Quality of life (European Quality of Life Scale).
Instruments Mini-Mental State Examination (MMSE) Beck Depression Inventory (BDI) Barthel Index NIH Stroke Scale (NIHSS) Visual Analogue Scale (VAS) European Quality of Life Scale (EQLS)
- Being tested
- Health education Program
- Keywords
- Ischemic stroke, Nursing, Depression, Health education, Quality of life
- Medical subject headings
- Ischemic Stroke, Health Education, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education ProgramBehavioural
The program consists of three core components: Session 1: Early stroke symptoms and recognition; Session 2: Living with stroke and daily self-care; and Session 3: Mood management. Additionally, a workshop (Session 4) will be delivered to address depressive symptoms through the development of coping strategies such as full-breathing techniques, relaxation methods, psychotherapy-based exercises, and mindfulness. All sessions will preferably be conducted in group format. Detailed session content is provided in Annex II.
Considering that 35 patients will receive the health education program, an estimated 3-4 groups of 8-12 participants will be formed, each attending the sessions under the same instructor.
Schedule
The sessions will be delivered over two separate days:
Day 1 (40 minutes):
Session 1: Early stroke symptoms and their recognition Session 2: Living with stroke: daily care and self-management
Day 2 (40 minutes):
Session 3: Mood and depression management Session 4: Relaxa
| Study group | Role | What they receive |
|---|---|---|
| Psychological Intervention | Experimental | The educational sessions are based on meaningful learning and incorporate constructivist, cognitive, and behavioral approaches. The program consists of three core components:
Session 1: Early stroke symptoms and recognition Session 2: Living with stroke: daily care and self-management Session 3: Mood management
In addition, a workshop (Session 4) will be delivered focusing on depression management through the development of coping strategies, including full-breathing techniques, relaxation exercises, psychotherapy tools, and and mindfulness practices.
Considering that 35 patients will receive the health education program, an estimated 3-4 groups of 8-12 participants will be formed, each attending the sessions with the same instructor. Receives: Behavioral: Health education Program |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Symptoms
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI). This measure evaluates changes in mood and depressive symptomatology in patients who have experienced an ischemic stroke. Scores will be compared between the intervention group (receiving the health education program) and the control group to determine the effect of the nursing-led intervention on depression levels.
Measured: Baseline, 3 months, and 6 months post-intervention
Health-Related Quality of Life
Quality of life will be assessed using the European Quality of Life Scale (EQLS). Comparisons between intervention and control groups will evaluate the effect of the nursing-led health education program on overall well-being and life satisfaction in post
Measured: Baseline, 3 months, and 6 months post-intervention
Cognitive Status
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). Scores will be compared between the intervention and control groups to evaluate the effect of the nursing-led health education program on cognitive performance in post-ischemic stroke patients.
Measured: 3 months, and 6 months post-intervention
Autonomy and Performance in Activities of Daily Living
Autonomy and the ability to perform basic activities of daily living will be measured using the Barthel Index. The study will compare changes in functional independence between the intervention and control groups.
Measured: Baseline, 3 months, and 6 months post-intervention
Neurological Deficit
Neurological deficits will be assessed using the National Institutes of Health Stroke Scale (NIHSS). Differences between intervention and control groups will be analyzed to determine the impact of the health education program on neurological recovery.
Measured: Baseline, 3 months, and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Félix Martínez Eiriz, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343284
- Sponsor's protocol ID
- 2025/419
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nursing Intervention Based on Health Education on Functionality, Depression Symptoms, and Quality of Life in Patients With Ischemic Stroke: A Quasi-Experimental, Longitudinal, and Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07343284
- Acronym / sponsor ID
- 2025/419
- Keywords
- Ischemic stroke, Nursing, Depression, Health education, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Jan 2026 (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.
This study is titled "Effect of a Nursing Intervention Based on Health Education on Functionality, Depression Symptoms, and Quality of Life in Patients with Ischemic Stroke." It is a quasi-experimental, longitudinal, prospective clinical trial that will beconducted with patients who have suffered an ischemic stroke and were treated in the neurology unit of the Lucus Augusti University Hospital, the same center where this study will take place.
The primary objective of the study is to determine the effect of a nursing intervention based on health education on quality of life and depression symptoms in individuals who have experienced an ischemic stroke.
To achieve this objective, variables such as cognitive status, depression symptoms, autonomy and ability to perform basic activities of daily living, neurological deficits, and quality of life will be assessed.
Regarding the total number of subjects to be studied, according to the Stroke Atlas in Galicia published by the Spanish Society of Neurology in 2018, the autonomous community of Galicia had a population of 2,701,819 inhabitants. Applying an incidence rate of 187.4 cases per 100,000 inhabitants according to the IBERICTUS study, an estimated 5,064 new stroke cases occur each year in Galicia. The province of Lugo had 324,842 inhabitants as of January 1, 2024, according to the INE; therefore, applying the same incidence rate, an estimated 609 new stroke cases occur per year. Considering the proportion of ischemic strokes compared to other types of strokes (80:20), the estimated number of ischemic stroke cases in Lugo would be 487. The representative sample size of stroke patients in the province of Lugo would be 70 patients, with 35 patients receiving the intervention and 35 serving as controls.
Independent Variables:
Sociodemographic: sex, age, event date. Clinical: stroke type, treatment modality (rt-PA or thrombectomy), falls, pain, pressure ulcers, aspiration, pneumonia, dysphagia, vital signs.
Health education: received vs. not received.
Dependent Variables:
Cognitive status (MMSE). Depression symptoms (BDI). Autonomy and ADL performance (Barthel Index). Neurological deficits (NIHSS). Quality of life (European Quality of Life Scale).
Instruments Mini-Mental State Examination (MMSE) Beck Depression Inventory (BDI) Barthel Index NIH Stroke Scale (NIHSS) Visual Analogue Scale (VAS) European Quality of Life Scale (EQLS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention | Experimental | Behavioral: Health education ProgramThe educational sessions are based on meaningful learning and incorporate constructivist, cognitive, and behavioral approaches. The program consists of three core components: Session 1: Early stroke symptoms and recognition Session 2: Living with stroke: daily care and self-management Session 3: Mood management In addition, a workshop (Session 4) will be delivered focusing on depression management through the development of coping strategies, including full-breathing techniques, relaxation exercises, psychotherapy tools, and and mindfulness practices. Considering that 35 patients will receive the health education program, an estimated 3-4 groups of 8-12 participants will be formed, each attending the sessions with the same instructor. |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anterior or posterior cerebral occlusion
Key exclusion criteria (4 listed)
- Intracranial hemorrhage
- Pregnancy
- Cognitive incapacity for participation
- Refusal to participate in the study and administer the questionnaires.
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 |
|---|---|---|
| Health education ProgramThe program consists of three core components: Session 1: Early stroke symptoms and recognition; Session 2: Living with stroke and daily self-care; and Session 3: Mood management. Additionally, a workshop (Session 4) will be delivered to address depressive symptoms through the development of coping strategies such as full-breathing techniques, relaxation methods, psychotherapy-based exercises, and mindfulness. All sessions will preferably be conducted in group format. Detailed session content is provided in Annex II. Considering that 35 patients will receive the health education program, an estimated 3-4 groups of 8-12 participants will be formed, each attending the sessions under the same instructor. Schedule The sessions will be delivered over two separate days: Day 1 (40 minutes): Session 1: Early stroke symptoms and their recognition Session 2: Living with stroke: daily care and self-management Day 2 (40 minutes): Session 3: Mood and depression management Session 4: Relaxa | Behavioural | Psychological Intervention |
Primary outcome
Depression Symptoms
Time frame: Baseline, 3 months, and 6 months post-intervention
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI). This measure evaluates changes in mood and depressive symptomatology in patients who have experienced an ischemic stroke. Scores will be compared between the intervention group (receiving the health education program) and the control group to determine the effect of the nursing-led intervention on depression levels.
Health-Related Quality of Life
Time frame: Baseline, 3 months, and 6 months post-intervention
Quality of life will be assessed using the European Quality of Life Scale (EQLS). Comparisons between intervention and control groups will evaluate the effect of the nursing-led health education program on overall well-being and life satisfaction in post
Cognitive Status
Time frame: 3 months, and 6 months post-intervention
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). Scores will be compared between the intervention and control groups to evaluate the effect of the nursing-led health education program on cognitive performance in post-ischemic stroke patients.
Autonomy and Performance in Activities of Daily Living
Time frame: Baseline, 3 months, and 6 months post-intervention
Autonomy and the ability to perform basic activities of daily living will be measured using the Barthel Index. The study will compare changes in functional independence between the intervention and control groups.
Neurological Deficit
Time frame: Baseline, 3 months, and 6 months post-intervention
Neurological deficits will be assessed using the National Institutes of Health Stroke Scale (NIHSS). Differences between intervention and control groups will be analyzed to determine the impact of the health education program on neurological recovery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Health education Program in people with Ischemia Stroke and Post-stroke Depression, run by University of Santiago de Compostela.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Félix Martínez Eiriz (+34 649678815, felix.martinez.eiriz@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Symptoms (time frame: Baseline, 3 months, and 6 months post-intervention). The study lists 5 primary outcomes in all. 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 15 Jan 2026.