Evaluation of the Effect of Animated Video-Assisted Nutrition Education on Nutritional Behaviors, Symptom Severity, and Quality of Life in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Mean Score on the Heart Failure Dietary Behavior Scale
研究概览
简要总结
This randomized controlled trial aims to evaluate the effect of animation video-supported nutrition education on dietary behaviors, symptom severity, and quality of life in patients with heart failure. A total of 70 patients aged 45-60 years with NYHA class II or III heart failure will be recruited at Tokat Gaziosmanpaşa University Research and Application Hospital Cardiology Clinic. Participants will be randomly assigned to an intervention group, which will receive video-supported nutrition education, or a control group, which will receive standard care. Outcomes will be assessed using the Heart Failure Dietary Behavior Scale, Heart Failure Symptom Status Scale, and Minnesota Living with Heart Failure Questionnaire at baseline, 1 month, 3 months, and 6 months.
详细描述
This study investigates the effect of animation video-supported nutrition education on dietary behaviors, symptom severity, and quality of life in patients with heart failure (HF). The study will be conducted at Tokat Gaziosmanpaşa University Research and Application Hospital Cardiology Clinic from July 2025 to December 2025. A total of 70 patients aged 45-60 years with NYHA class II or III HF will be included. Patients meeting the inclusion criteria and willing to participate will be randomly assigned to the intervention or control group using a computer-based simple randomization method.
The intervention group will receive a structured nutrition education program delivered through animation videos developed based on clinical guidelines, focusing on balanced nutrition, sodium restriction, sugar and cholesterol control, and fluid retention prevention. Videos will illustrate key concepts using the "5W1H and Symptom" (What, Where, How, When, Why, Symptom) principle. Baseline assessments will include the Heart Failure Dietary Behavior Scale, Heart Failure Symptom Status Scale, Minnesota Living with Heart Failure Questionnaire, and a demographic form. Follow-up assessments will be conducted at 1 month, 3 months, and 6 months.
The control group will receive standard care, including verbal advice from cardiologists. After completion of the study, control group patients will also have access to the animation video education. Data will be analyzed using SPSS v25 with appropriate statistical tests, and linear mixed-effects models will be applied to evaluate group, time, and group-time interaction effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who have been diagnosed with heart failure at least six months ago,
- •Are between the ages of 45-60,
- •Are in NYHA stage II or III,
- •Have a mobile phone capable of watching videos,
- •Volunteer to participate in the study will be included in the study.
排除标准
- •Individuals with HF who were included in the study as a sample,
- •Patients with fluid restriction under a different protocol (e.g., Chronic Renal Failure),
- •Patients with chronic pulmonary disease (e.g., COPD),
- •Illiterate,
- •Do not own a mobile phone capable of watching videos,
- •Have physical or cognitive impairments,
- •Have a psychiatric illness,
- •Refuse to participate in the study will not be included in the study.
- •Patients hospitalized during the study period will be excluded from the study, and their data will not be subject to statistical analysis.
结局指标
主要结局
Mean Score on the Heart Failure Dietary Behavior Scale
时间窗: At baseline, 1 month, 3 months, and 6 months
Dietary behaviors will be evaluated using the Heart Failure Dietary Behavior Scale, developed by Boy and Enç (2022). The scale consists of 19 items across four subscales: Healthy Habits, Salt Restriction, Sugar Restriction, and Prevention of Fluid Retention. Items are rated on a 4-point Likert scale, yielding a total score range of 19-76. Higher scores indicate better adherence to dietary recommendations. A cutoff score of 46 is used; scores ≥46 indicate adherence to guideline-recommended nutritional behaviors.
次要结局
- Mean Score on the Heart Failure Symptom Status Scale (Symptom Severity)(At baseline, 1 month, 3 months, and 6 months)
- Mean Score on the Minnesota Living with Heart Failure Questionnaire (Quality of Life)(At baseline, 1 month, 3 months, and 6 months)
研究者
Yasemin BOY
Research Assistant
Tokat Gaziosmanpasa University