The Effect of a Structured Nursing Education Program on Attitudes Toward Diet Therapy, Self-Care, and Chronic Disease Self-Management in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Participant Information Form
研究概览
简要总结
This randomized controlled trial was designed to evaluate the effects of a structured nurse-led education program on attitudes toward diet therapy, self-care activities, and chronic disease self-management among patients undergoing maintenance hemodialysis. Sixty eligible patients receiving maintenance hemodialysis were randomly assigned to either the intervention group (n = 30) or the control group (n = 30). Participants in the intervention group received a structured nurse-led education program consisting of eight face-to-face educational sessions delivered over four weeks (two sessions per week), while the control group received routine care without additional educational intervention. The primary outcomes were attitudes toward diet therapy, self-care activities, and chronic disease self-management, which were assessed before and after the intervention using the Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), the Self-Care Activities Screening Scale-14 (SCAS-14), and the Chronic Illness Self-Management Scale (CISMS).
详细描述
This randomized controlled trial was designed to evaluate the effects of a structured nurse-led education program on attitudes toward diet therapy, self-care activities, and chronic disease self-management among patients undergoing maintenance hemodialysis.
The study was carried out in the hemodialysis unit of a private dialysis center in the Black Sea region of Türkiye. Sixty eligible patients receiving maintenance hemodialysis were randomly assigned to either an intervention group (n = 30) or a control group (n = 30). Cluster randomization at the dialysis-session level was used to minimize contamination between participants. Outcome data were analyzed by a blinded statistician.
Participants in the intervention group received a structured nurse-led education program consisting of eight face-to-face sessions delivered over four weeks (two sessions per week). The educational program included chronic kidney disease and hemodialysis, treatment adherence, dietary therapy, nutritional management, fluid and electrolyte restrictions, self-care skills, chronic disease self-management, anemia management, and reinforcement of learning. The control group received routine care without additional educational intervention.
The primary outcomes were attitudes toward diet therapy, self-care activities, and chronic disease self-management. These outcomes were assessed at baseline and immediately after completion of the intervention using validated instruments, including the Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), the Self-Care Activities Screening Scale-14 (SCAS-14), and the Chronic Disease Self-Management Scale (CDSMS).
The educational program was developed based on Orem's Self-Care Deficit Nursing Theory and was designed to address self-care, dietary therapy, and chronic disease self-management among patients undergoing maintenance hemodialysis.
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
- Single (Outcomes Assessor)
盲法说明
This was a single-blind randomized controlled trial. Due to the nature of the educational intervention, participants and the nurse educator could not be blinded. However, the statistician who analyzed the study data was blinded to group allocation, and anonymized data were used during statistical analysis.
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
- •Adults aged 18 years or older.
- •Receiving maintenance hemodialysis treatment.
- •Able to communicate in Turkish.
- •Able to read and write.
- •Willing to participate and provided written informed consent.
排除标准
- •Cognitive impairment or severe psychiatric disorder preventing participation.
- •Serious medical condition preventing completion of the education program.
- •Participation in another structured educational intervention during the study period.
- •Withdrawal of consent before completion of the study.
结局指标
主要结局
Participant Information Form
时间窗: Baseline and immediately after completion of the 4-week intervention
The Participant Information Form was developed by the researchers to collect participants' sociodemographic and clinical characteristics. The questionnaire included items on age, sex, educational level, marital status, smoking status, alcohol consumption, and duration of hemodialysis treatment.
Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS)
时间窗: Baseline and immediately after completion of the 4-week intervention
The Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), originally developed by Onbe and Kanda (2018), was used to evaluate patients' attitudes toward dietary therapy. Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS). The scale consists of 16 items scored on a 4-point Likert scale, with total scores ranging from 16 to 64. Higher scores indicate more positive attitudes toward diet therapy. The scale consists of 16 items distributed across three subscales: Behavioral Tendency Influenced by Cognition (BTIC) (7 items), Behavioral Tendency Influenced by Food Culture (BTIFC) (6 items), and Negative Effects Leading to Dietary Modification (NELDM) (3 items). Each item is rated on a four-point Likert scale. The final three items are reverse scored. Higher total scores indicate more positive attitudes toward dietary therapy.
Self-Care Activities Screening Scale (SASS-14)
时间窗: Baseline and immediately after completion of the 4-week intervention
Self-care activities were assessed using the Self-Care Activities Screening Scale (SASS-14), which comprises 14 items grouped into four subscales: Health Consciousness (HC), Nutrition and Physical Activity (NPA), Sleep (SLP), and Interpersonal and Intrapersonal Coping Skills (IICS). Items are rated on a six-point Likert scale, yielding total scores ranging from 14 to 84, with higher scores indicating greater engagement in self-care activities. In the original validation study, the overall Cronbach's alpha coefficient was 0.80 (Bermejo-Martins et al., 2021). The Turkish adaptation demonstrated good internal consistency, with a Cronbach's alpha coefficient of 0.85 (Tarus et al., 2024).
Chronic Disease Self-Management Scale (CDSMS)
时间窗: Baseline and immediately after completion of the 4-week intervention
Chronic disease self-management was assessed using the Chronic Disease Self-Management Scale (CDSMS). The instrument consists of 21 items across four subscales: Self-Stigma (7 items), Coping with Stigma (5 items), Health Care Efficacy (4 items), and Treatment Adherence (5 items). All items are scored using a five-point Likert scale. The reported Cronbach's alpha coefficients for the subscales range from 0.715 to 0.879. The Turkish validity and reliability study of the instrument was conducted by Öztürk et al. (2021). Chronic Disease Self-Management Scale (CDSMS). The scale consists of 21 items scored on a 5-point Likert scale, with total scores ranging from 21 to 105. Higher scores indicate better chronic disease self-management.
次要结局
未报告次要终点
研究者
Yasemin OZYER
Associate Professor
Sinop University