Efficacy of Fluid Distribution Timetable on the Treatment Adherence of End-Stage Renal Disease Patient: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intradialytic Weight Gain
研究概览
简要总结
Nonadherence to fluid restriction is a significant issue among hemodialysis patients globally, with numerous adverse health outcomes. These outcomes include increased intradialytic weight gain, acid-base and electrolyte imbalances, and decreased mental health. This study aimed to determine the effects of a fluid distribution timetable on adherence to fluid restriction among patients with end-stage renal disease undergoing hemodialysis. The study utilized a single-blind, randomized-controlled efficacy trial design. Selected ESRD patients undergoing hemodialysis are then randomized using computer-generated sequences of randomly permuted blocks stratified according to sex to receive the intervention or the control group. Adherence to fluid restriction was measured using the dialysis thirst inventory and intradialytic weight gain. The variables were computed using One-way Repeated Measures Multivariate Analysis of Variance and Multivariate Analysis of Covariance. Secondary outcomes included baseline patient demographic profile and was compared according to group allocation. Both group were followed up for four weeks, assessing the outcome measures during the third hemodialysis session for each week
详细描述
Chronic Kidney Disease (CKD), a condition wherein the kidney is damaged and cannot filter blood properly (National Institute of Diabetes and Digestive and Kidney Diseases, 2019), if left untreated, end-stage renal disease (ESRD) otherwise known as kidney failure occurs. CKD has been recognized as one of the major public health problems globally and has an estimated prevalence of 13.4% of the total population and ESRD has an estimate between 4.902 million to 7.083 million cases. According to the CKD Health Policy Model, it is projected that there would be an increase of 16.7% cases of CKD in adults in the year 2030.
Hemodialysis is a maintenance management form of renal replacement therapy. It is a treatment to filter the excess fluid and blood wastes by using a special filter that is considered as an artificial kidney. However, hemodialysis alone is not a treatment for this disease, with the help of fluid restriction and change of dietary prescription the quality of life of the patient may significantly improve.
In the perspective of hemodialysis patients, adherence to dietary regimens and fluid restrictions is a great challenge due to the burden of constant choices about food and drink, the adaptation to complex eating patterns, existing cultural practices, and the competing demands of the chronic disease and comorbidities.
Adherence to fluid restriction is a major problem among hemodialysis patients around the world and persists to be a clinical concern in nephrology care. and a clinical problem in nephrology care. Nonadherence to fluid restriction as defined by the National Kidney Foundation is gaining an intradialytic weight of more than 5.7% of their weight post hemodialysis session. Nonadherence to fluid restriction are found to have numerous health-related problems, an increased intradialytic weight gain, acid-base and electrolyte imbalances, and a decrease in mental health. Other than themselves, the hemodialysis patient must also consider the burden of their home caregivers such as the management of family costs, the maintenance of physical and psychological health, the provision of care, the assumption of multiple roles, and the communication of expectations are challenges as a caregiver.
This study is a single-blind, single center, randomized-controlled trial that utilized data collection triangulation to assess the efficacy and feasibility of a nursing intervention that will promote treatment adherence to fluid restriction among hemodialysis patients in a private tertiary level institution in Manila, Philippines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with End-stage renal disease
- •Oliguric (urine output of less than 20ml/ hr)
- •Aged 40 - 70 years old
- •Had been on dialysis for at least 6 months
- •Is alert and oriented
- •With scheduled for hemodialysis thrice a week.
排除标准
- •Pregnant patients
- •Has a history or overt mental illness
- •Patients with congestive heart failure
结局指标
主要结局
Intradialytic Weight Gain
时间窗: 4 Weeks
It is the net increase in body weight from previous post-dialysis weight measured in kilograms
Perceived Thirst Score
时间窗: 4 Weeks
The Dialysis Thirst Inventory (DTI) measured perceived thirst among the participants. It is a 7-item questionnaire answered on 5-point Likert scale, with scores ranging from 7 to 35 and higher scores indicating higher thirst. No cut-off score is present for the questionnaire; however, higher scores are interpreted as higher perceived thirst.
次要结局
- Sex(Week 1)
- Educational Attainment(Week 1)
- Age(Week 1)
- Edema Status(Week 1)
- Ultrafiltration Goal(Week 1)
研究者
Joshua Nathaniel Ellano
Principal Investigator
University of Santo Tomas
