Nursing Health Education to Improve Functionality and Quality of Life After Ischemic Stroke
NCT ID: NCT07343284
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2026-06-01
2027-12-01
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Psychological Intervention
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.
Health education Program
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
Usual Care
No interventions assigned to this group
Interventions
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Health education Program
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy
* Cognitive incapacity for participation
* Refusal to participate in the study and administer the questionnaires.
18 Years
ALL
No
Sponsors
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University of Santiago de Compostela
OTHER
Responsible Party
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Félix Martínez Eiriz
Collaborating Investigator
Central Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2025/419
Identifier Type: -
Identifier Source: org_study_id
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