DialysisPro

A MOBILE APPLICATION APPROACH TO IMPROVING

END STAGE RENAL DISEASE OUTCOMES

Isner, Justin Clay;McCall, Elaine;McPhatter, Lesley

UNIVERSITY OF VIRGINIA HEALTH SYSTEMS | DIETIETIC INTERNSHIP

Literature Review
Chronic Kidney Disease (CKD) is a progressive and irreversible loss of kidney function.
The National Kidney Foundation (NKF) classifies five stages of CKD listed in Table 11. Prior to
stage 5, the patient is referred to as predialysis or non-dialysis. At stage 5 also known as End
Stage Renal Disease (ESRD) dialysis or transplant becomes necessary. Currently, over 400,000
individuals receive some form of renal replacement therapy in the United States to mitigate the
effects of ESRD.2 For the vast majority, hemodialysis, a blood purification treatment 3 times
weekly, provides lifesaving therapy. Dialysis performs some of the kidneys functions such as
removing extra salt and water from the body; it also removes toxins normally filtered by the
kidneys and maintains safe levels of vitamins and minerals in the body.3 Notable outcomes of
dialysis include improvements in blood pressure control while reducing antihypertensive
medication, an improvement in serum albumin and hemoglobin levels, and a simultaneous
reduction in erythropoietin-stimulating agent, calcium and phosphate levels.3
National Kidney Foundation Stages

Evaluation Criteria

Stage 1 CKD

GFR < 110 mL/min (with evidence of intrinsic renal damage)

Stage 2 CKD

GFR < 90-60 mL/min (with evidence of intrinsic renal damage)

Stage 3 CKD

GFR 60 - 30 mL/min (no need for evidence of intrinsic renal

damage)

Stage 4 CKD

GFR 30 15 mL/min

Stage 5 CKD

GFR < 15 mL/min or ESRD

Table 1: National Kidney Foundation stages of chronic kidney disease

Unfortunately, not all aspects of kidney disease can be completely addressed with
dialysis therapy. One aspect includes the strict dietary regimen required of ESRD patients.
Patients on dialysis are faced with the paradoxical issue of having a catabolic disease that
requires higher than average protein and energy intake paired with having to avoid excess
minerals often abundant in the standard American diet (SAD). For most patients, potassium and
phosphorous are the most important electrolyte abnormalities and the most difficult to control in
their diet. Phosphorous and potassium are ubiquitous in both processed and unprocessed foods.
Phosphate is notably high in dairy and meat products, as well as in processed foods where it is
used as a preservative compound.4 Potassium can be found in many fresh fruits and vegetables
with particularly high concentrations in tomatoes, potatoes, oranges and bananasfoods
prevalent in the SAD. Elevated potassium is associated with cardiac arrhythmias and is linked to
the leading cause of death in ESRD patients, sudden cardiac death.5 Elevated phosphorus is
associated with vascular calcification and overall higher mortality.6 Failure to gain adequate
control of these micronutrients may also lead to bone mineral disease.
MINERAL BONE DISEASE
The other aspect of CKD and ESRD that complicates medical therapy are the
disturbances in mineral, vitamin D, and parathyroid hormone (PTH).7,8 As an ESRD patients
glomerular filtration rate (GFR) decreases, secondary hyperparathyroidism (SHPT) begins to
emerge.8 Decreasing GFR alone cannot explain SHPT. Instead there are many contributing
factors to SHPT that include, but are not limited to, deficiencies in 1,25dihydroxycholecalciferol, decreased expression of vitamin D receptor and calcium sensing
receptor, hyperphosphatemia, hypocalcemia, and skeletal resistance to PTH9.

During standard physiological functioning, changes in the extracellular calcium

concentrations stimulate PTH production. What ensues is a series of cascading events triggered
by the release of PTH-- the release of calcium into the serum through bone resorption and; the
kidneys are stimulated to reabsorb calcium to convert 25-hydroxyvitamin D to the active form
1,25-dihydroxycholecalciferol. 7 Parathyroid hormone levels continue to rise as CKD progresses
not because of changes in serum calcium or phosphorous, but because of the decrease in active
form of 1,25-dihydroxycholecalciferol levels that no longer promote calcium absorption. Left
untreated, a disorder grossly labeled mineral bone disease can result in which increased bone
remodeling and loss of bone density occur. In addition, other manifestation of the disease,
unrelated to bone structure, may occur that include arterial stiffening; cardiovascular, arterial,
and valvular calcifications; calciphylaxis, and erythropoietin-resistant anemia. All of which may
increase mortality and are often irreversible and decrease medical therapy efficacy.7 To further
complicate the pathophysiology excess dietary phosphorus stimulates synthesis and secretion of
PTH independent of serum calcium and vitamin D.10 Phosphorus control remains the primary
therapy for the prevention and treatment of MBD (i.e. SHPT, vascular calcification).
Interventions to control phosphorus include dialysis treatment, controlled dietary intake and use
of phosphorus binders (medications that bind phosphorus in the gastrointestinal tract and
prevent/decrease absorption of phosphorus into the bloodstream).
EXISTING MODEL FOR MANAGING EXCESS MINERAL INTAKE AND MINERAL
BONE DISEASE
Abnormalities in electrolytes clearly have significant health impact and are under-treated by
conventional hemodialysis. As such, a large burden of dietary compliance to manage phosphorus

and potassium intake is placed on the patient. Despite support from the interdisciplinary team
and dietary instruction and education with a registered dietitian, many patients struggle with this
aspect of care.
The current model of dietary management involves monthly meetings with dialysis unit
based nutritionists and physicians. Patients are encouraged and instructed on how to take
phosphorous binding pills which are self-administered with meals and snacks. Monthly labs are
used to track blood levels of phosphorous and potassium. Despite this model, patients have no
mechanism of support when they are outside of the dialysis unit, where most meals are taken.
MOBILE APPLICATIONS
Engaging patients via mobile applications, hereafter, may be referred to as apps may
provide a solution to the need for enhanced support of good dietary choices. Currently over 5
billion people worldwide own and use cellphones11, making an application driven approach
attractive. Wiseman et al. implemented a smartphone photo-based initiative to monitor wounds;
92% of participants were willing to take pictures of their wounds and 68% of those patients were
willing to do it daily.11 The Wiseman study confirmed that in the dermatological field, 90% of
patients were willing to participate and comply with mobile application follow ups, but noted
that only approximately 1 in 5 participants own a smart phone; making smart phone ownership a
potential barrier to mobile application follow up success in any field.11 Sevick et al implemented
a simpler personal device assistant (PDA)-based dietary self-monitoring program for
hemodialysis patients. 12 Their mobile intervention focused on the use of a diary (BalanceLog) to
track participants meals so calories, potassium, and phosphorus intake could be monitored.
Balance Log showed that some participants were consuming as little as 40% of their required
calories, but serum potassium and phosphorous levels showed no discernable pattern in relation

to the diary intervention.12 However, it was noted that the diary approach reduced the time
required by a dietitians to assess the source of dietary problems when laboratory results were
outside of normal rangeEven when laboratory data were normal, the dietitian can quickly
scroll through the log records to identify eating patterns that may result in future problems.12
Welch et al took the PDA diary method a step further by trialing a Dietary Intake
Monitoring Application (DIMA), an electronic self-monitoring application for PDAs.13 DIMA
combines a nutritional database with a UPC database as well as displays participants intake in
relation to their dietary goals to promote self-awareness of performance attainment.13 The results
of the DIMA study were promising; at week six there was a marginal decrease in calories in all
participants, active users also had a decreased sodium and protein intake.13 Welch et al tested the
acceptability of DIMA on a scale of 1-5, with the mean acceptability being 3.86 (range: 2.684.68) showing that participants were willing to use a mobile tracking system as a disease
management tool.13
Campbell and Porter performed a systematic review on mobile apps and their effect on
nutritional indicators in chronic renal disease. Their review found sources supporting mobile
nutrition applications versus conventional techniques often result in better adherence to selfmonitoring and changes in diet.14 However results conflicted over the effectiveness of mobile
applications on altering specific nutrient intakes to alter serum levels. Campbell and Porter
reviewed four studies that assessed sodium intake; all reported a decrease in daily sodium intake
however none of the studies found statistical significance in that sodium reduction.14 Two studies
reviewed showed a decrease in potassium, fluid, and energy intake. However, again, none were
statistically significant. Results for phosphorus and protein intakes were conflicting with studies
showing an increase, decrease, and no change so no clear trend could be determined.14 Lastly, in

the two studies that measured serum potassium, phosphorus, albumin, or C-reactive protein no
clear trends for change could be determined.14 Despite the lack of statistical significance,
Campbell and Porter suggest that the use of mobile apps for dietary self-monitoring may
provide beneficial effects on intradialytic weight gain, fluid, potassium, and sodium intakes in
dialysis patients.14
Current literature on the topic of mobile apps and their effects on improving diet
adherence and outcomes for ESRD are limited. Most studies are strictly PDA based, with the
focus being on keeping a dietary log. No ESRD (or CKD) specific studies were found that
utilized advanced features of smart phones such as cameras or real time data transmission.
Mobile applications utilizing these features have been implemented in other areas of practice,
such as dermatology11, and have been shown to be successful and accepted by patients. As
experts in the nutrition field, dietitians have a unique opportunity to develop an easy to use
mobile application that allows for quick communication between nutrition professionals and
participants in regards to meals. Developing such an application has the potential to increase the
accuracy of dietary information dietitians have access to as well as improve the health outcomes
of the mobile application users.
PURPOSE
In this pilot study, in conjunction with Health Decision Technologies, we plan to develop
a food reporting and evaluation application, DialysisPro, for ESRD patients on hemodialysis. As
a pilot study, the major aim is to test the feasibility and engagement of patients toward a renal
diet specific application. DialysisPro will allow the patients to provide a food log of digital
images. Renal dietitians will grade meals for phosphorous and potassium content, providing in
app results to patients in a timely manner. Data will be collected on the number of images

provided, the number of phosphate binding pills consumed and metrics of interaction with the
application. Patients will also be surveyed to assess their opinions of DialysisPro and its features.
METHODS
The Dialysis Pro pilot study enrolled eight patients with ESRD on hemodialysis from two
University of Virginia dialysis location: the Kidney Center in Charlottesville, VA and the UVA
Lynchburg Dialysis Center in Lynchburg, VA. An MD, NP, or dialysis unit technician assessed
patients during their dialysis appointment to determine eligible candidates for the pilot study.
Inclusion and exclusion criteria can be found in Table 2
Inclusion Criteria

Exclusion Criteria

Age 18 or older

Severe or obvious cognitive or physical impairment preventing use

of smart phone or ability to give informed consent

Ability to sign informed consent

Ability to speak and read English
Diagnosis of ESRD and currently receiving hemodialysis
Ownership of a smart phone and the ability to transmit images using
that smart phone

Table 2. Inclusion and Exclusion Criteria for the DialysisPro pilot study.
Once a pilot study candidate was identified, screening and consent was performed at the
dialysis unit in person by a DialysisPro study team member. The DialysisPro study team
members were clinicians and dietitians who used their weekly/monthly patient rounds as an
opportunity to conduct the screening process. The screening consisted of determining if the
patient has a smart phone (Android version 4.4.4 or later or iPhone 4 or later) with a data plan
allowing photographs to be transmitted. Team members also assessed the individuals

proficiency with their smartphone (can the individual find and open apps easily and can they take
and send photographs). Dialysis treatments last three to four hours, providing ample time for
patients to read, or have the consent read to them, with ample opportunity for questions and
explanation. Patients could request the opportunity to consent in a private room at the dialysis
unit or chairside during their regularly scheduled dialysis session. Patients were also allowed to
take the consent home for further review if desired.
After completing the screening and consent process, participants were offered a two page
survey to assess their knowledge of phosphorous and potassium containing foods. The survey
was administered chairside by the unit dietitian. This initial survey was compared with an end of
trial survey to assess for improvement in knowledge base. Once the survey was completed, the
assisting study member downloaded DialysisPro via a secure website onto the participants
smartphone. Following download and installation, the study member provided a structured
fifteen to thirty minute tutorial on the application covering the following areas:
How to access the application from their phones home screen
How to navigate the DialysisPro app, specifically how to reach the meal photo
submission page
How to take and send photographs using DialysisPro
How to provide a description or details about the items pictured
How to enter the number of phosphorous binder pulls taken with each meal
How to view in application feedback received from the dietitians
After the training session was completed, the participants were asked to demonstrate their
understanding and use of the app with the survey team member through the application. Each

phone / participant pair was assigned a unique 5 digit ID number. The 5 digit code was used to
store all study related information with a crosswalk table stored in a secure spreadsheet.
At each meal, participants were asked to submit a photograph of their meal along with a
description and the number of phosphorus binders taken with the meal. The photographs were
transmitted to a secure server and assigned to the 5 digit ID number associated with that patient.
The original photographs were auto-erased by the application once a successful submission had
occurred. Dietitians accessed the meal photos via a secure web portal and independently
evaluated each meal on a 1 5 scale for phosphorous and potassium content. The ideal
turnaround time for each meal submission was 48-72 hours or less. Once a meal evaluation was
completed, the participant received an updated bar chart inside the DialysisPro app with their
estimated phosphorous and potassium intake over 7 days in bar chart format. In addition, a
monthly report for each patient was generated to track monthly averages and rates of data
submission over the 3 month trial. Patient supplied meal data and dietitian scoring, dialysis
attendance records, adequacy records (a measure of how effective dialysis cleans blood) and
usual monthly dialysis labs were also recorded. These data are collected every month for all
dialysis patients across the country and thus did not require any additional lab draws or effort.
Collecting these lab values allowed for identification of trends towards improvement in
phosphorous and potassium associated with app use and as input to a potential future longer trial.
Participants phosphorous and potassium levels were reviewed in the preceding 12 months
before trial participation. At the completion of the three month trial, the application was
uninstalled from the participants smartphone by a study member. After the uninstallation, the
potassium and phosphorous content survey was re-administered to evaluate for improvements
knowledge.

The expected screening failure rate was 50-60% due to lack of smartphone ownership or
insufficient operating knowledge. We expected a low dropout rate due to the short length of the
trial however, this was not the case. Lastly, there were no obvious risks to patients participating
in the study. The potential benefits were improving the nutritional content of foods selected by
dialysis patients thereby improving their overall nutrition choices and health.
RESULTS
Fourteen individuals were approached and agreed to participate in the DialysisPro study (eight at
the UVA Kidney Center in Charlottesville, VA and six the UVA Lynchburg Dialysis Center in
Lynchburg, VA). Of the fourteen participants who began the study, only eight (57%) remained
enrolled at the completion of the study. Of the eight individuals who remained in the study five
were males and three were female, three were African American, and 5 were Caucasian.
Participants were 23 to 63 years old.
The average serum phosphorous and potassium levels for study participants in the two months
preceding the study were 5.78 mg/d and 4.68 mg/dL respectively. After 60 days using
DialysisPro, the average serum phosphorous and potassium values had both increased to 6.13
mg/dL and 4.74 mg/dL respectively. Although it is tempting to conclude that DialysisPro had no
effect on serum phosphorous or potassium, or worsened them, three of the eight participants had
a decrease in serum phosphorous and three in serum potassium as seen in Tables 3 and 4.

Pre Study

Phosphorus
After 60 Days of Dialysis
Pro

+/- of
Participant January February Average March April Average
Average
1
5.8
5.3
5.55
4.5
4.8
4.65
-0.9
2
4.1
4
4.05
3.1
3.5
3.3
-0.75
3
5
6.5
5.75
4.5
6.9
5.7
-0.05
4
6.6
4.9
5.75
5.9
6.3
6.1
0.35
5
5.6
6.4
6
6.7
5.8
6.25
0.25
6
7.3
6.3
6.8
7.2
7
7.1
0.3
7
8.4
6.5
7.45
7.2
7.9
7.55
0.1
8
5.4
4.3
4.85
9.2
7.7
8.45
3.6
Table 3. A comparison of the pre study and DialysisPro study day 60 serum phosphorus values (mg/dL).

Pre Study

Potassium
After 60 Days of Dialysis
Pro

+/- of
Participant January February Average March April Average Average
1
4
3.7
3.85
3.7
3.4
3.55
-0.3
2
3.8
4
3.9
4.2
3.9
4.05
0.15
3
5.9
5.8
5.85
5.4
5.4
5.4
-0.45
4
5.1
5.1
5.1
4.8
4.5
4.65
-0.45
5
5.7
5.9
5.8
6.1
6.6
6.35
0.55
6
4.6
5.7
5.15
5.1
5.5
5.3
0.15
7
4.1
4.6
4.35
4
5
4.5
0.15
8
3.2
3.7
3.45
4.5
3.8
4.15
0.7
Table 4. A comparison of the pre study and DialysisPro study day 60 serum potassium values (mg/dL).

An assessment of increased ESRD diet knowledge as a consequence of participating in the

DialysisPro study could not be measured at this time. A pre-test was given (Appendix), however,
the test will not be re-administered until the completion of the study, day 90. An assessment of
DialysisPro usage also could not be performed. Data cannot be gathered using Google Analytics
until the completion of the study. In lieu of this, patient interviews were carried out with three of
the participants to gather qualitative feedback. Of the three participants interviewed, all three

would like a commercial version of this mobile application with enhanced features such as being
able to input types of binders used instead of just the number of binders used. However, all three
participants said the current version, though easy to use, did not provide them with useful
feedback to help them understand or correct their current diet. This issue will be explored in the
discussion. Lastly, two of the three participants interviewed said they would prefer the app to be
linked to a database that provided exact values for phosphorous and potassium content versus the
current 1-5 grading system manually done by a dietitian.
DISCUSSION
Caution must be used in drawing any conclusions from these interim results of this small pilot
study. Although the average serum phosphorous and potassium increased for the majority (63%)
of the participants, it was encouraging to see three participants improve their lab values. Of note,
two of the three most active study participants, by number of meals submitted, saw a decrease in
both their serum phosphorous and potassium levels. Although not statistically significant, it is
promising. Interviewed participants attributed their success to feeling accountable and becoming
more aware of phosphorous and potassium content in foods outside of their normal sphere.
The greatest and the most useful part of the interim assessment involved identifying limitations
and areas for improvements for the application and study. The inability to recruit and retain
patients throughout the study proved to be the greatest challenge. Moreover, the issue is why
there were so few study participants begs a greater question. Insight into the answer is as
follows: the typical patient running on dialysis is of an older age (average age 55 years old) and
of a lower socioeconomic status. These factors combined translate into fewer smart phones in the
hands of patients and low smart phone literacy as older generations have not relied on
technology as much as current and younger generations. There is some discrepancy among the

numbers, however, about 20 % of Kidney Center patients owned smart phones at the time of
recruitment (n- 20 patients) and those outside of the study group that did own smart phones felt
that it would be a burden to take pictures with a phone as they did not feel adept at using their
phones. This hints at a major issue with developing mobile applications for this population. The
applications may be ahead of their time with the current demographics at these two facilities.
However, this does not mean that application development should stop. In fact, this should
encourage more application development so that we may provide future generations the
technology that they have become used to. If an application can be developed now, that is more
user friendly enough for the current generation, it can be built upon as time progresses by adding
more features and depth as newer more technologically savvy patients begin dialysis. In this
respect, DialysisPro is acting as a foundational cornerstone, from which improvements can be
made and features added, for both the current generation of dialysis patients and future
generations to come.
Another limitation to the DialysisPro application was the phosphorous and potassium results
display in the user interface. The graphs were clunky and minimally helpful. One patient
interviewed reported it would have been helpful to allow the user to tap the bar and be given the
list of foods that composed that particular bar and their respective percentages so the user could
understand what foods were contributing the most to the phosphorous or potassium levels. In that
same vein the grading system was flawed by both human error and poor design. For example,
compare the following two graphs:

Figure 1. 30 day phosphorous, potassium, and number of binders used summary for participant 1.

Figure 2. 30 day phosphorous, potassium, and number of binders used summary for participant 2.

Both graphs are summaries over the same 30-day period of phosphorous, potassium, and number
of binders used for two separate participants. When comparing the graphs, participant two
consistently had a higher binder intake than participant one and a comparable phosphorous
intake, if not less based strictly on the bar graph. When labs were reviewed for this 30-day period
participant ones serum phosphorous was 3.5 mg/dL and participant twos serum phosphorous
was 6.9 mg/dL. This example highlights a major shortcomings of a non-standardized grading

scheme. Both patients appear to be well under their daily phosphorous intake and taking
adequate or more than adequate binders, especially in participant twos case. However, the graph
does not indicate that participant two needs to make any adjustments to his/her diet. Essentially,
the graphs do not translate to actual phosphorus intake, and, therefore, inhibits efforts to educate
patients and even for a patients ability to self-manage and adjust intake of inappropriate foods
the very purpose of the application is thereby defeated.
A third limitation to this small pilot study was accessibility to technical support for both
participants and study leaders. The application was developed by Health Decisions Technology
located in Oakland California. Our only form of contact with the developer was email or skype
conferences. This made any changes very slow, and limited the number of changes that could be
made in such as short study period. In the future it would be beneficial to use a local mobile
application developer who can work in person with the team and work on implementing changes
in frequent application updates. Similarly, features of the application were incomprehensible and
useless from the health care professional standpoint. The user graphs that are pictured above are
also available to the health care team on the administrative side. Unfortunately, these graphs
could not be printed or reviewed with participants because they could not be fitted to a page to
print and the phosphorous/potassium target lines would not print or would disappear. This could
be easily remedied if it were possible for the study team to sit down with a developer and discuss
the issue in person.
CONCLUSION
In summary, the interim results from this small pilot study cannot be used to determine if a
mobile application can be an effective tool that will be utilized by patients to improve their
knowledge of the ESRD diet or improve their laboratory values. However, these results can be

used to identify numerous limitations to both the DialysiPro study design and applications such
as small sample size, population with insufficient technological knowledge, lack of technical
support, lack of application functionality, and lack of standardized meal scoring protocol.
Identification of these limitations is critical in moving forward with application development for
this population. Using DialysisPro as a corner stone to build off of, future mobile applications
can be designed for a dialysis generation to come that may demand more smart phone user
interaction. The outcomes of a few compliant patients, though not statistically significant, are
promising anecdotal evidence that a future more comprehensive study with an updated mobile
application and protocols may be warranted.

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Appendix

Date___________ Patient Study ID Number_________Facility:

________________

Gender: Male

Female

Years on Dialysis________

____________________________________________________
You and a friend decide to go out to a restaurant for lunch. The
following foods are listed on the menu.
Circle YES if it is a good choice, and NO if it is a
bad choice.
Hamburger on a Bun
Tuna Salad on White Bread
Fresh Roast Beef Sandwich
Grilled Chicken Sandwich
Spaghetti with Tomato Sauce
Cottage Cheese and Fresh Fruit
French Fries
Baked Potato with Melted Cheese
Mashed Potatoes with Gravy
Macaroni Salad
Coleslaw
Tossed Salad with Oil and Vinegar
Apple Pie
Cheesecake

yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes

no
no
no
no
no
no
no
no
no
no
no
no
no
no

If your POTASSIUM level was 5.8 mg/dl on your last laboratory report,
1. Is this level of potassium high, low or acceptable? (circle one)
High

Low

Acceptable

2. Circle any food items in the above list that would be high sources of
POTASSIUM.

You arrive at a friend's house for dinner and the following foods are
available for you to select from.
Circle YES if it is a good choice, and NO if it is a bad
choice.
Homemade Chicken Noodle Soup
Crackers with Peanut Butter
Buffalo Chicken Wings
Beef Barbecue on white roll
Macaroni and Cheese
Three-bean salad (green, yellow, kidney)
Potato Salad
Pretzels
Peanuts
Iced Tea
Cola
Fruit Cup (peaches, pears, pineapple, apple)
Chocolate cake

yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes

no
no
no
no
no
no
no
no
no
no
no
no
no

If your PHOSPHORUS was 6.1 mg/dl on your last laboratory report,

1. Is this level of Phosphorus high, low or acceptable? (circle one)
High
Low
Acceptable
2. Circle any food items in the above list that would be high sources of
PHOSPHORUS.

Thank you for taking the time to complete our survey!