Hemodialysis Eating Education Intervention in Hemodialysis Patients
Condition: Hemodialysis Complication
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Mental health The mental health was assessed by the Center for Epidemiologic Studies Short
      Depression Scale (CES-D 10). Patient will be asked about the ways they may have felt or
      behaved during the past week on the scale from rarely or none of the time to all of the time.
      Scale is the sum of the points for all 10 items. If more than 2 items are missing, do not
      scale. A scale of 10 or greater is considered depressed.

      Quality of Life The quality of life among hemodialysis patients will be assessed using the
      Short Form-12 health survey subscale of the Kidney Disease and Quality of Life (KDQOL), with
      items measuring general health, activity limits (physical functioning), ability to accomplish
      desired tasks (role physical), role emotional, emotional well-being, energy level, pain, and
      social activities [7]. The SF-12 scale was validated in hemodialysis patients in Chinese
      population [8, 9].

      Healthcare utilization Frequency of usage of emergency services, end-stage renal disease
      (ESRD)-related hospitalizations over past 6 months.

      Patients' characteristics and health related behaviors Age (year), gender (male/female),
      marital status (married, single, divorce, widowed), highest education attainment (elementary
      school, junior high school, senior high school, college/university and above), ability to pay
      for medication (very difficult, fairly difficult, fairly easy, very easy), self-assessed
      social status (low, middle, high).

      The physical activity was assessed by using valid and reliable Chinese version of the
      international physical activity questionnaire short form (IPAQ-SF) [10-12]. This 7-item
      survey aims to identify the frequency and duration of vigorous, moderate, and light PA, as
      well as inactivity during the past one week. Patients will be asked about frequency and
      amount of alcoholic beverage drinking in the last 30 days, and smoking status (non-smoker,
      occasional smoker, smoker).
    

Intervention name(s): Hemodialysis eating index (HDEI) base education intervention
Intervention type(s): Behavioral
Intervention description(s): The investigators have developed the educational materials for patients, in order to improve the dialysis outcomes. The interventions will be delivered to patients and nurses in hospital based hemodialysis centers.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: quasi-experimental design with 4 groups
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hemodialysis, nutrition education