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
| Registry | NCT07343284 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 70 (Estimated) |
| Sponsor | University of Santiago de Compostela (Other) |
| Conditions | Ischemia Stroke, Post-stroke Depression, Post-stroke, Quality of Life, Health Education |
| Interventions | Health education Program (Behavioral) |
| Dates | start 2026-06-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-01-15, last updated 2026-01-15 |
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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)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Psychological Intervention | Experimental | Behavioral: Health education Program | 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. |
| Usual Care | No intervention |
Sex: All, ages: 18 Years to any
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.