Not Yet Recruiting

NCT Number: NCT07343284

Nursing Health Education to Improve Functionality and Quality of Life After Ischemic Stroke

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)

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Ischemia Stroke Adherence Interventions Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Health Behavior Health Education Ischemic Stroke Medication Adherence Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Post-stroke Post-stroke Depression Quality of Life Stroke Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Anterior or posterior cerebral occlusion

Exclusion criteria

Intracranial hemorrhage
Pregnancy
Cognitive incapacity for participation
Refusal to participate in the study and administer the questionnaires.

Treatment and study plan

Health Education Program

Behavioral

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

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Félix Martínez Eiriz

CONTACT

[email protected]

+34 649678815

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Jan 15, 2026
Registry last updated: Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting