Hemodialysis Eating Education Intervention to Improve the Depression, Treatment Adherence, Cardiovascular Risks, Quality of Life, and Healthcare Utilization Among Hemodialysis Patients: A Quasi-experimental Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Health Literacy
研究概览
简要总结
The investigator aim to evaluate the effect of training program on treatment adherence, quality of life, cardiovascular risk factors, depression, and healthcare utilization. The investigator conducted a quasi experimental study. The investigator also examine the effect of interaction between health literacy and training program on depression, treatment adherence, cardiovascular risk factors, quality of life, and healthcare utilization.
The ultimate goal is to improve the dietary intake and dialysis outcomes for all hemodialysis patients in Taiwan. The investigator therefore will the SaaS dietary educational platform for this purpose.
详细描述
The investigator have completed the surveys on dietary intake, anthropometrics, clinical assessments, body compositions, and biochemical parameters and so on in designed hospitals. Assessment of cardiovascular disease risk factors: The diagnosed values were defined by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative Work Group.
Health Literacy Health literacy will be also measured by Chew's 3 brief health literacy screening questions (BHLS), each with 5 possible response options [1]: (1) "How often do participants have problems learning about participants' medical condition because of difficulty understanding written information?" (always, often, sometimes, occasionally, or never); (2) "How often do participants have someone help participants read hospital materials?" (always, often, sometimes, occasionally, or never); and (3) "How confident are participants filling out medical forms by participants self?" (extremely, quite a bit, somewhat, a little bit, or not at all). The BHLS demonstrated evidence of construct validity among hemodialysis patients [2]. To identify the level of health literacy, sum scale of 3 screening questions will be calculate and classify into 3 levels: (1) Limited health literacy (=< 6 scale); (2) Marginal health literacy (7-8 scale); (3) Adequate health literacy (>= 9 scale) on the scale of 15 scale [3].
Dietary knowledge The dietary knowledge of nurses and patients will be evaluated pre-intervention and post-intervention, using a 10-item questionnaire developed by Kim and colleague [4]. The tool is to measure knowledge on protein, potassium, phosphorus, sodium, and water. The correct answer was treated as 'correct', incorrect or 'do not know' answers were treated as 'incorrect'; the highest scale possible was 10 points.
Treatment adherence Biological markers: The bio-markers to identify the dietary adherence are serum potassium (Pre-dialytic serum potassium ≤ 5.5 mEq/L), and phosphorus (Pre-dialytic serum phosphorus ≤ 4.5 mg/dL); fluid adherence is inter-dialysis weight gain (IDWG ≤ 4% of dry weight gain); medication adherence are (phosphate binders, antihypertensive, calcium supplements, and vitamin).
Self-report: The subjective adherence will be measured using the adherence behaviors subscale of the ESRD-Adherence Questionnaire (ESRD-AQ) [6]. The four subscales will be used which ask about treatment adherence to hemodialysis treatment (item 14 "During the last month, how many dialysis treatments did participants miss completely?", 17 "During the last month, how many times have participants shortened participants' dialysis time?", and 18 "During the last month, when participants' dialysis treatment was shortened, what was the average number of minutes?"), medications (item 26 "During the past week, how often have participants missed participants' prescribed medicines?"), fluid restrictions (item 31 "During the past week, how often have participants followed the fluid restriction recommendations?"), and diet recommendations (item 46 "During the past week, how many times have participants followed the diet recommendations?"). The ESRD-AQ is designed with the 5-point Likert scale, such that higher scales indicate better adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodialysis patients whose aged 20-75 years, received hemodialysis treatment thrice a week for at least 3 months, the education level of junior high school and higher, and Kt/V > 1.2.
排除标准
- •Hemodialysis patients with obvious edema, pregnancy, amputation, hyperthyroidism, hypothyroidism, malignancy, liver failure or cancer, mental disorders, tube feeding, hospitalization and plan to surgery, loss to measure body composition, and percentage body fat < 4% were excluded.
结局指标
主要结局
Health Literacy
时间窗: baseline
Health literacy will be also measured by Chew's 3 brief health literacy screening questions (BHLS), each with 5 possible response options: (1) "How often do you have problems learning about your medical condition because of difficulty understanding written information?" (always, often, sometimes, occasionally, or never); (2) "How often do you have someone help you read hospital materials?" (always, often, sometimes, occasionally, or never); and (3) "How confident are you filling out medical forms by yourself?" (extremely, quite a bit, somewhat, a little bit, or not at all).
次要结局
- Dietary knowledge(2 months)
研究者
Shwu-Huey Yang
Professor
Taipei Medical University
