Clinical trial NCT05466773: Hemodialysis Eating Education Intervention in Hemodialysis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Keywords: hemodialysis, nutrition education
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Taipei Medical University Hospital
name: Cathay General Hospital
name: Taipei Medical University WanFang Hospital
name: Taipei Medical University Shuang Ho Hospital
First posted: 2022-07-20
Enrollment: 141
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: quasi-experimental design with 4 groups
Primary purpose: PREVENTION

Brief 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).

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Health Literacy
timeFrame: baseline
Secondary outcomes:
measure: Dietary knowledge
timeFrame: 2 months
Other outcomes:
measure: Treatment adherence-biological markers
timeFrame: 4 months
measure: Treatment adherence-hemodialysis treatment
timeFrame: 4 months
measure: Mental health
timeFrame: 4 months
measure: Patients' characteristics and health related behaviors
timeFrame: baseline
measure: Healthcare utilization
timeFrame: 4 months
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
state: Other (Non U.s.)
Study officials:
affiliation: Taipei Medical University
name: Shwu-Huey Yang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
citation: Cavanaugh KL, Osborn CY, Tentori F, Rothman RL, Ikizler TA, Wallston KA. Performance of a brief survey to assess health literacy in patients receiving hemodialysis. Clin Kidney J. 2015 Aug;8(4):462-8. doi: 10.1093/ckj/sfv037. Epub 2015 Jun 10.
citation: Wallace LS, Rogers ES, Roskos SE, Holiday DB, Weiss BD. Brief report: screening items to identify patients with limited health literacy skills. J Gen Intern Med. 2006 Aug;21(8):874-7. doi: 10.1111/j.1525-1497.2006.00532.x.
citation: Duff EA, Chawke FM. A service review to assess if innovative intensive phosphate dietary education can help reduce phosphate levels to the recommended range in a hemodialysis population. Hemodial Int. 2017 Oct;21 Suppl 2:S22-S26. doi: 10.1111/hdi.12593.
citation: Kim Y, Evangelista LS, Phillips LR, Pavlish C, Kopple JD. The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ): testing the psychometric properties in patients receiving in-center hemodialysis. Nephrol Nurs J. 2010 Jul-Aug;37(4):377-93.
citation: Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994 Oct;3(5):329-38. doi: 10.1007/BF00451725.
citation: Wan EY, Chen JY, Choi EP, Wong CK, Chan AK, Chan KH, Lam CL. Patterns of health-related quality of life and associated factors in Chinese patients undergoing haemodialysis. Health Qual Life Outcomes. 2015 Jul 29;13:108. doi: 10.1186/s12955-015-0308-3.
citation: Joshi VD, Mooppil N, Lim JF. Validation of the kidney disease quality of life-short form: a cross-sectional study of a dialysis-targeted health measure in Singapore. BMC Nephrol. 2010 Dec 20;11:36. doi: 10.1186/1471-2369-11-36.
citation: Macfarlane DJ, Lee CC, Ho EY, Chan KL, Chan DT. Reliability and validity of the Chinese version of IPAQ (short, last 7 days). J Sci Med Sport. 2007 Feb;10(1):45-51. doi: 10.1016/j.jsams.2006.05.003. Epub 2006 Jun 30.
citation: Liou YM, Jwo CJ, Yao KG, Chiang LC, Huang LH. Selection of appropriate Chinese terms to represent intensity and types of physical activity terms for use in the Taiwan version of IPAQ. J Nurs Res. 2008 Dec;16(4):252-63. doi: 10.1097/01.jnr.0000387313.20386.0a.