Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05797766 |
| Other study ID # |
REC-2022-08-095-RN |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
January 18, 2023 |
| Est. completion date |
May 5, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
University of Santo Tomas |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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
