Effectiveness of Skill Building Education on Arteriovenous Fistula Self-Care Behaviors and Quality of Life of Patients on Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Assessment of Self-Care Behaviors with AVF in Hemodialysis Patients (ASBHD-AVF)
研究概览
简要总结
The purpose of this study is to assess the effectiveness of skill building educational interventions in improving the self-care behaviors and quality of life of AVF in hemodialysis patients. This study will address questions.
What is the effect of skill building education on the self-care behaviors of AVF care and quality of life in patients in patients undergoing hemodialysis treatment? A total 274 participants will be recruited from dialysis units of the study hospitals. Using random allocation 137 participants will be assigned to the control group and 137 to the intervention group. The intervention group will additionally receive a skill building education for improving their self-care behaviors and quality of life of AVF.
Researcher will implement skill building educational intervention in interventional group to enhance the self-care behaviors and quality of life. This intervention have two session, first is theoretical and another one is practical. The primary outcome of this study is AVF self-care behaviors and secondary outcome is quality of life related to AVF. This outcome will be assessed using the Self-care Behaviors Scale with Arteriovenous Fistula in Hemodialysis patients (ASBHD-AVF). The secondary outcome will be assessed using the Hemodialysis Access-related Quality of Life (HARQ) which is a self-administered tool develop by Nordyke.
The primary and secondary outcomes will be assessed at: baseline, after the completion of the intervention, and follow-up data will be collected at the second and sixth weeks after intervention is completed. Data will be analyzed using the Statistical Package of Social Science (SPSS) version 25. Descriptive statistics, means and standard deviations will be used for the continuous variables, while frequencies and percentages will be utilized for categorical demographic data (gender, educational level, hemodialysis frequency, items of self-care behavior scale, QOL). Normality of data will be check and applied test accordingly.
详细描述
Hemodialysis treatment requires vascular access. The AVF is a long-lasting and effective vascular access. Dysfunction of AVF leads to numerous complications such as infection, bleeding, stenosis, aneurysm, and thrombosis. Taking care of AVF, its cleanliness, maintenance, daily monitoring of AVF, and engaging in strengthening exercises and management can enhance the effectiveness of dialysis treatment.
The middle range theory of chronic illness is utilized for the development of this intervention that possesses three components: self-care maintenance, self-care monitoring, and self-care management. The most common AVF self-care maintenance instructions include refraining from applying pressure on the AVF, avoiding blood pressure monitoring and blood sampling from the AVF arm. The primary objective of self-care monitoring is to differentiate the normal anatomy and physiology from abnormal conditions or changes in the body. Recognizing the physical changes initiates the decision-making process regarding the necessary course of action. Routine monitoring of AVF blood flow can be accomplished by palpating the AVF site with the palm to detect the presence of a thrill. Additionally, the identification of bruit can be detected by auscultating/using a stethoscope. In self-care management, the patients can evaluate the treatment implementation. Patients who manage their self-care can improve their health status, and overall well-being, and enhance their quality of life.
The randomize control trial (RCT) parallel design with the allocation ratio 1:1 will be employed.
The control group will receive the routine care information at the hemodialysis units. The health care staff provides the usual routine care to patients during their regular dialysis procedures.
Intervention group will receive skills building education that include didactic and practical session Timing of the intervention will set based on the overall health status of patients. Each participant will receive individualized didactic instruction and personalized practical training before the dialysis procedure start. These two sessions will be delivered on separate days within the same week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Data analyst will assist with permuted block randomization procedure will be used to separate random scheme in both setting (A) and (B). The sealed envelopes will be prepared by data analyst, shuffled, numbered serial, and placed in a locked drawer in both units (A and B), and only research assistant can access it. After consenting and completing baseline assessment, the research assistant will open a sealed envelope to reveal the patient's group assignment. The patient will then be assigned to specific group accordingly. Research assistant will ensure that intervention and control groups' patients will have dialysis in separate rooms or wards to prevent contamination in intervention. The sealed envelop will be coded with numbers the research assistant will not know what these numbers mean.
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •The study will include patients:
- •diagnosed with end-stage renal disease on hemodialysis through an arteriovenous fistula
- •aged 18 years or above.
- •who can read and understand the Urdu language.
排除标准
- •Exclusion Criteria
- •The study will exclude patients:
- •having any physical or mental disabilities that can interfere with their capacity to perform daily life activities.
- •with any visual and hearing impairment. -
研究组 & 干预措施
Interventional
Skill building educational intervention will be implemented into two session. First is theoretical and other is practical. In theoretical session patients will be teach about the AVF self-care behavior. In practical session patient will be teach about how to monitor their AVF. Monitoring of AVF include the assessment of AVF. Assessment have three steps. Inspection, palpation and auscultation.
干预措施: Skill building education (Behavioral)
usual care
Control group will receive usual care in the dialysis units.
结局指标
主要结局
Assessment of Self-Care Behaviors with AVF in Hemodialysis Patients (ASBHD-AVF)
时间窗: 4 months
Primary outcome of this study will be the assessment of self-care behaviors related to AVF in hemodialysis patients. The ASBHD-AVF is a 16 itme self-assessment scale develop by Sousa et al (2015) to assess self-care behaviors of AVF of hemodialysis patients. This scale consists of two sub scale: 1) Management of sign and symptom and 2) Prevention from complication. Response option consists of five point Likert scale ranging from 1(nevern develop the self-care)-5 (always develop the self-care). The minimum scores is 16 and maximum is 80.A higher scores reflect higher frequency of self-care behaviors. Permission of this tool is taken. The overall reported reliability is 0.72 and CVI is1.
次要结局
- Hemodialysis Access-Related Quality of Life (HARQ)(4 months)
研究者
Bushra Sultan
Assistant Professor
Shifa Tameer-e-Millat University