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
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Depression Symptoms
概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anterior or posterior cerebral occlusion
排除标准
- •Intracranial hemorrhage
- •Pregnancy
- •Cognitive incapacity for participation
- •Refusal to participate in the study and administer the questionnaires.
研究组 & 干预措施
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.
干预措施: Health education Program (Behavioral)
Usual Care
结局指标
主要结局
Depression Symptoms
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Félix Martínez Eiriz
Collaborating Investigator
University of Santiago de Compostela