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

January 7, 2026 updated by: Félix Martínez Eiriz, University of Santiago de Compostela

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: 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.
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, and 6 months post-intervention
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
Baseline, 3 months, and 6 months post-intervention
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.
3 months, and 6 months post-intervention
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.
Baseline, 3 months, and 6 months post-intervention
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.
Baseline, 3 months, and 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Santiago de Compostela

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/419

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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