Efficacy Trial of Fluid Distribution Timetable
Condition: End-stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      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
    

Detailed description: 
      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.

      Sample size computation using G*Power 3.1.7 showed that a sample size of 40 respondents is
      necessary to achieve a power of 80%, attrition rate of 20%, partial η2 of 0.41, effect size
      of 0.79 and significance level of 5% (two-tailed). A group allocation of 1:1 was used in five
      data collection timeframes. The participating patients was allocated randomly into two
      groups, the intervention, and the control group, using a computer-generated sequence of
      random permuted blocks. The randomization was stratified according to the participants' sex
      and was done by an independent statistician. The groupings was not be disclosed to the
      participants and the unit's personnel in the duration of the study but was be disclosed once
      the study is done.

      Upon consenting, the participants were then divided into two groups using stratified,
      permuted block randomization. The control group received standard care that consists of 10 to
      15 minutes of face-to-face health teaching of their treatment regimen including management of
      medication, vascular access, dietary and fluid, and hemodialysis schedule. The intervention
      group received a combination of standard care and the intervention, the fluid distribution
      timetable. The fluid distribution timetable is a scheduled distribution of predetermined
      amounts of fluid intake daily depicted in a 5x6 table. The timetable has three major columns.
      The first column has six-time points of a day with a four-hour interval. The second column,
      which was divided into four sub-columns, reflects the percentage of fluid allotment for food,
      activities, medication, and thirst encounters. The percentage of fluid allocation was
      computed based on the patient's prescribed fluid restriction, usual time of food intake per
      day, usual level of activity, time of medication intake, and common time they encounter
      thirst for a day. The third column indicates the converted percentage of fluid allotment into
      milliliters. The researcher shall provide a 210 ml glass for accuracy and uniformity of
      measurement of fluid intake at home. The predetermined fluid restriction was determined by
      the participant's nephrologist. The trained staff nurses was able to teach the intervention
      to the participant and their primary care provider. The trained nurses answered any questions
      and queries of the participant or the primary care provider until they understand the
      intervention fully. If there are questions that the trained nurses cannot answer, the trained
      staff nurse shall inform the researcher and be answered as soon as possible. The researcher
      provided multiple copies of the fluid distribution table for each participant in the
      intervention group. The participants was observed for one month and follow up with their
      fluid distribution timetable every last day of their hemodialysis for the week and shall be
      collected by the researcher.

      The prerecorded video used for training may also be used for the patient's queries and may
      also be a guide at home. If the patient has difficulty in understanding the terms that the
      intervention uses, the researcher may explain the intervention in layman's terms for better
      understanding. If there is an existing language barrier, the researcher may explain the
      intervention in the Filipino language. The veracity of the participants can be verified in
      their intradialytic weight gain in between their previous hemodialysis weight gain and their
      current pre-hemodialysis weight gain. To eliminate threats to internal validity, the
      researcher randomized all consented participants upon acquiring informed consent and divided
      them into two evenly distributed groups, the control and intervention group to eliminate
      selection bias. The control group is formed to eliminate the threat to history and
      maturation. To eliminate the threat to temporal ambiguity, the researcher gathered the data
      of baseline thirst scores and interdialytic weight of all participants. In the event that the
      participant is unable to attend their scheduled hemodialysis session, the researcher may
      adjust their schedule as long as they have their hemodialysis three times per week and if
      they fail to commit to this condition, the participant shall be removed from the study.

      Adherence to fluid restriction was measured by utilizing two indicators, thirst and
      intradialytic weight gain, and was compared using One-way Repeated Measures Multivariate
      Analysis of Variance and Multivariate Analysis of Covariance. The thirst was measured using a
      standardized tool, the dialysis thirst inventory, which was self reported by the
      participants. The intradialytic weight weight gain was computed by determining the difference
      of the current pre-hemodialysis session weight and the previous post hemodialysis weight.
      Secondary outcomes included the baseline demographic profile and were compared according to
      treatment allocation. Both groups were followed up fort four weeks, assessing the outcome
      measures on the third hemodialysis session of the week
    

Intervention name(s): Fluid Distribution Timetable
Intervention type(s): Behavioral
Intervention description(s): a scheduled distribution of predetermined amounts of fluid intake daily depicted in a 5x6 table. The timetable has three major columns. The first column has six-time points of a day with a four-hour interval. The second column, which was divided into four sub-columns, reflects the percentage of fluid allotment for food, activities, medication, and thirst encounters. The percentage of fluid allocation was computed based on the patient's prescribed fluid restriction, usual time of food intake per day, usual level of activity, time of medication intake, and common time they encounter thirst for a day. The third column indicates the converted percentage of fluid allotment into milliliters.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: End-stage Renal Disease; Fluid Distribution Timetable; Thirst; Interdialytic weight; Nephrology Nursing; Hemodialysis