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Not yet recruiting NCT07343284

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

No phase Interventional Ischemia Stroke Post-stroke Depression Post-stroke Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health education Program.
Who it may be relevant to
Registry conditions: Ischemia Stroke, Post-stroke Depression, Post-stroke, Quality of Life. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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)

Interventions

  • 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

Primary outcome measures

  • Depression Symptoms [Time frame: Baseline, 3 months, and 6 months post-intervention]
  • Health-Related Quality of Life [Time frame: Baseline, 3 months, and 6 months post-intervention]
  • Cognitive Status [Time frame: 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]
  • Neurological Deficit [Time frame: Baseline, 3 months, and 6 months post-intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07343284 · 2025/419

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗