Improving Care for Peritoneal Dialysis Patients With the CKD-PD App
Phase: NA
Conditions: Kidney Failure, Chronic, Peritoneal Dialysis Complication
Sponsor: Massachusetts General Hospital

 
 
 
  
Proposal 
  
Title: 
 
Improving Care for Peritoneal Dialysis Patients with the 
“CKD-PD” app 
  
Detailed Proposal: 
 
Version 4 Dated 2 March, 2021 
      
 
 
 
      
 
NCT04797195 
 
Funding 
1R21TW010963-01 
 
Principle Investigators 
 
Massachusetts General Hospital, Harvard University 
Katharine Morley, MD MPH 
 
Srinagarind Hospital, Khon Kaen University 
Sirirat Anutrakulchai MD PhD 
 
 
 
 
 

2 
 
 
Summary 
The number of patients in Thailand with end stage renal disease on peritoneal dialysis (PD) is growing rapidly. 
Thai nephrologists have identified a critical gap in the current management of PD patients: a lack of timely 
information about fluid (hydration) status. Real time access to this information creates the opportunity for the 
early treatment of overhydration - the most common cause of complications and hospitalization in this population.  
Early treatment of overhydration in PD patients can decrease the incidence of complications, improve quality of 
life, and decrease health care costs. 
      
Our research project aims to improve the monitoring of fluid status in PD patients from a bimonthly, in-clinic 
review of handwritten log books to a smartphone based app (“CKD-PD”) with digitized data. This allows for near 
real time data visualization, hydration status monitoring, outlier notifications, and more timely treatment 
interventions for overhydration. Data from home monitoring equipment will be transferred      to the CKD-PD 
app using near field communication (NFC) – a novel, low cost solution for automatic data entry.  Hydration 
metrics are uploaded to the chronic kidney disease database “CKDNET” in the Thai Care Cloud - Thailand’s 
national health database, merging patient collected data with hospital and clinic records. 
 
The objective of our proposed study is to determine if use of the CKD-PD app can improve early treatment of 
overhydration in PD patients. Aim 1 of our research proposal is to optimize the usability of the CKD-PD app. We 
will employ user surveys based on the Unified Theory of the Acceptance and Use of Technology model, 
observations using the “Think Aloud” methodology and % completion of hydration metrics. Using these results, 
we will conduct a process improvement project with 3 rapid cycles to iteratively improve the CKD-PD app 
usability. In Aim 2, we will conduct a randomized clinical trial comparing the incidence of clinical interventions 
for treatment of overhydration. PD patients from Srinagarind Hospital, Khon Kaen Hospital, and Chaiyaphum 
Hospital nephrology clinics in Northeastern Thailand (N=200) will be randomized into two groups – one using 
the CKD-PD app, and one receiving usual management. Our primary outcome will be the incidence of clinical 
intervention to treat overhydration as an intermediate outcome related to our secondary outcomes: complications, 
hospitalizations, and mortality related to fluid overload. We will measure the effect size of the app usage on these 
secondary outcomes.  
Design 
Process improvement (Aim 1) 
Interventional randomized control trial (Aim 2) 
      
Populations 

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Adult patients with chronic kidney disease on peritoneal dialysis 
      
Study site 
Srinagarind Hospital, Khon Kaen University, Khon Kaen Thailand (Aim 1) 
Srinagarind Hospital, Khon Kaen Hospital, and Chaiyaphum Hospital (Aim 2) 
      
Aims 
        
 
Our proposed study objective is to answer the question:  
          Does the use of the CKD-PD app improve early treatment of overhydration in PD patients compared 
with those receiving usual care?  
 
          Aim 1: Optimize the usability of the CKD-PD app and validate hydration metrics collection with NFC 
Aim 2: Conduct a randomized controlled trial to determine if using the CKD-PD app improves early treatment of 
overhydration by comparing the incidence of clinical interventions to treat overhydration in CKD-PD app users 
and non-users.  
Hypothesis: Use of the CKD-PD app will allow for earlier treatment of OH compared to patients not using the 
app, thereby potentially reducing complications, hospitalizations, and mortality from congestive heart failure, 
infections, hypertensive emergencies, and major cardiovascular events.  
      
Background and significance 
Chronic kidney disease in Thailand 
The global prevalence of chronic kidney disease (CKD) is 11-13% [1] and increasing in low and middle-income 
countries paralleling the rising rates of diabetes and hypertension and lack of access to early CKD treatment [2,3]. 
The use of peritoneal dialysis (PD) for renal replacement therapy in patients with end-stage renal disease is 
increasing as many countries, especially in Asia, try to meet the increasing demand with limited resources [4,5,6]. 
In 2008, Thailand adopted a “PD first” policy in order to offer this benefit in its Universal Health Coverage 
Scheme [7], resulting in a 9-fold increase in PD patients from 2,760 to 24,244 from 2008 to 2015 [8]. PD is done 
at home; patients typically perform 4 exchanges of dialysate fluid per day into the peritoneal cavity to remove 
excess fluid and metabolic waste.  
Table 1: Admission of PD Patients 
Srinagarind Hospital 2016 (N=39 pts) 
Reason  
N (%) 
Volume overload* 
21(33) 
Peritonitis* 
13(20) 

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Other infections* 
9(14) 
Exit site infection 
4(6) 
Major Adverse Cardiac Event* 4(6) 
Catheter malfunction 
3(5) 
Severe Hypertension* 
2(3) 
Anemia 
3(5) 
Stroke* 
1(2) 
Others 
4(6) 
Total admissions 
77 (100) 
*Overhydration complication 
  
Peritoneal dialysis and overhydration 
Patients on peritoneal dialysis have frequent complications requiring hospitalization. Overhydration (OH), a 
qualitative description of fluid status, with excess fluid in the extracellular space [9], is one of the most common 
complications in PD patients. Clinical manifestations of OH include peripheral edema, congestive heart failure, 
pleural effusions, and hypertension [9]. It is estimated that 50-60% of PD patients are overhydrated, with severe 
OH producing clinical symptoms in 25% [10,11]. OH is associated with increased morbidity and mortality due 
to infections including peritonitis [12], and major adverse cardiovascular events such as myocardial infarction, 
pulmonary edema, stroke, and hypertensive crisis [9]. OH alone, independent of coexisting cardiovascular 
pathologies, is a risk for increased morbidity and mortality [13]. In 2016, at Srinagarind Hospital, at Khon Kaen 
University (KKU), Thailand, nearly half of the PD patients were hospitalized at least once, and some were 
hospitalized 2-4 times. Thirty-nine of the 91 patients (43%) were hospitalized a total of 77 times (some had 2-4 
admissions). Sixty-five percent (50/77) of the hospitalizations were OH related (Table 1). The 5-year survival 
rate for PD patients is 48% [14]. Sixty-five percent of the PD admissions were for OH and related complications, 
with an average cost of $3,000 USD/admission [14]. Extrapolating this data to a national level, the estimated cost 
for OH-related admissions in PD patients in Thailand is $37,500,000 USD/year.   
      
CKD and mobile health technology 
Early treatment of overhydration can decrease complications and hospitalizations, improve quality of life, and 
decrease costs for PD patients. OH can be managed with treatments such as diuretics and anti-hypertensive 
medications, adjustments in dialysis prescriptions, and sodium/fluid restrictions [9,15]. Early detection of OH is 
possible by monitoring patients’ hydration metrics: weight, blood pressure (BP), and ultrafiltration volume 
(difference between fluid input and output in dialysis). Currently, the critical gap lies in obtaining these hydration 
metrics in a timely and actionable format. A few studies have shown that smartphone and tele-monitoring 
programs are feasible and acceptable for patients with CKD [16-19]. Remote monitoring systems for PD patients 

5 
 
have been reported in India [20, 21] and Japan [22]. However, these studies used home visits, conventional mobile 
phones and computers, and did not include real time visualization of hydration metrics for management of OH. 
The eNephro RCT, underway in France, investigates the impact of tele-monitoring on clinical outcomes, cost, 
and quality of life for all CKD patients, but this is a high resource setting with low use of PD [23]. There is no 
good evidence about the impact of mHealth or remote monitoring on clinical outcomes in PD patients in low and 
middle-income countries where it is widely used. Our research aims to address this knowledge gap by 
investigating how mHealth technology can facilitate PD patient data collection and transform it into actionable 
information for nephrologists. We hope to shift the management paradigm of PD patients from bimonthly 
assessments to near real-time monitoring and early treatment.   
 
Chronic Kidney Disease- Peritoneal Dialysis app  (CKD-PD) 
Thai nephrologists identified a critical gap in the ability to monitor hydration status in PD patients in a timely 
fashion. Currently, they assess PD patients’ hydration status every 2 months by reviewing hydration metrics 
recorded in a handwritten logbook during their clinic visit or, more acutely, when patients decompensate and 
require urgent contact with PD clinic staff or hospitalization. They brought this issue to the KKU-MIT mHealth 
Hackathon in January 2017, an intensive 2-day event where multidisciplinary teams collaborate to develop an 
mHealth solution to a clinical problem. Joined by biostatisticians and software programmers from DAMASAC 
(Data Management and Statistical Analysis Center) at the KKU Faculty of Public Health, the team developed the 
CKD-PD app prototype. This initial work was followed by a user design process at Srinagarind Hospital 
nephrology clinic where patients and PD clinic staff worked with software engineers to improve the app. The app 
is Android based, with an iOS version in development. It is available for free download, but patients need to be 
registered for use. There are fields for entry of hydration metrics: weight, blood pressure, ultrafiltration volume 
(Fig 1). Near field communication (NFC) capability was recently added to the app for use with home scales and 
BP machines allowing automatic entry of hydration metrics. NFC has been widely used for wireless transfer of 
small amounts of data such as payments and transit cards [24]. There have been several research healthcare 
innovations using NFC [24-26], including home monitoring of pediatric populations [27] and in low income 
countries [28], chosen because of its simplicity and ease of use. It is now an emerging technology in commercial 
health care markets for home BP monitoring [29] and implantable glucose sensors [30]. CKD-PD with NFC 
allows patients, including those with limited technology skills, low literacy, or visual impairment to easily enter 
hydration metrics, by bringing their smartphone within 4 cm of the host NFC sensor. This information is uploaded 
via WIFI or cellular internet connection to the CKDNET (CKD-Northeast Thailand) database in the Thai Care 
Cloud, a national health database [31]. The data is graphically displayed on the CKD-PD web application 
accessible to PD clinic staff, and PD to patients on their smartphone. The key innovative features of the CKD-PD 
app are: 1) automated data entry for weight, BP and ultrafiltration volumes using NFC, 2) graphical display of 

6 
 
hydration metrics in the CKD-PD app, so patients can monitor their own hydration status 3) access to near real 
time data and alerts to PD clinic staff about critical abnormalities in patients’ hydration metrics, 4) enhanced 
communication between PD patients and clinic staff, 5) integration of patient collected data from the CKD-PD 
app with electronic longitudinal health data in the CKDNET database on the Thai Care Cloud. Combining these 
data types has potential to predict which patients are most likely to need early treatment intervention and serve as 
a platform for data analytics to improve outcomes. 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 1: Optimize the usability of the CKD-PD app and validate hydration metric collection with NFC 
 
Overall study design: This project will involve human subjects research at Srinagarind Hospital for participation 
in the optimization of the usability of the CKD-PD app, using process improvement methodology. It will involve 
collecting qualitative data from participant questionnaires and observation, and quantitative data from the 
CKDNET (Chronic Kidney Disease in NorthEast Thailand) database regarding their use of the CKD-PD app. A 
multidisciplinary team will review results and make iterative improvements to the CKD-PD based on whether or 
not the modification is expected to fulfill one or more of the following improvement criteria: 1) ease of use, 2) 
improved hydration metric monitoring, 3) increased user engagement and benefit, 4) facilitation of 
patient/provider communication. We have set thresholds after each improvement cycle to define successful 
optimization (Table 2). We will also compare hydration metrics collected using the CKD-PD app with hydration 
metrics collected directly by PD staff using usual methods. After completion of the 3 improvement cycles, we 
will conduct an implementation pilot of the CKD-PD app with a different group of 5 users. They will use the 
CKD-PD app for 1 week, collecting the same metrics as during the improvement cycles. The goal is to identify 
training and implementation issues, and assess usability with a different group of users. During the second week, 
research assistants will visit each participant at home collect hydration metrics, using PD clinic equipment (scales 
and BP cuffs) and compare with patient collected hydration metrics using CKD-PD app to assess validity of home 
collected hydration metrics with CKD-PD app.  
 
Subject population and assignment: Our subject population is patients with chronic kidney disease on peritoneal 
dialysis. Since all PD patients have end stage kidney disease, they have chronic illness. Some patients will have 
more advanced disease and other co-morbidities such as diabetes and hypertension that are commonly found in 
this population. We will recruit 10 participants for this study. All 10 participants will complete activities in 
improvement cycle 1, and then be randomly assigned to 2 equal groups. Group 1 will have 5 patients who will 
participate in improvement cycles 2 and 3. Group 2 will have 5 patients that will participate in the pilot 
implementation trial.  

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Inclusion criteria are  
-  patients with CKD from any cause on home based peritoneal dialysis 
-  receive care at the Srinagarind Hospital nephrology clinic, Khon Kaen University 
-  age ≥18  
-  access to a smartphone capable of running the CKD-PD app 
-  willingness to allow research staff in observe using CKD-PD app in home 
 
Exclusion criteria are 
- vulnerable populations specified as pregnant women, children, prisoners, institutionalized individuals, refugees. 
- inability to participate in home data collection 
 
Recruitment plan: The study population will be recruited from patients at the Srinagarind Hospital Nephrology 
clinic who are undergoing peritoneal dialysis. Participants will be informed about the possibility of participating 
in a research study using a smartphone app to help collect information about peritoneal      dialysis, which they 
currently collect using a handwritten log book. They will be provided with written and verbal information about 
the research study. All questions will be answered. Participation is completely voluntary, and participants can 
withdraw from the study at will. Inclusion criteria include: 1) on home-based peritoneal dialysis due to end stage 
renal disease from any cause, 2) age >18. The following exclusion criteria will be used: 1) vulnerable populations 
such as children, prisoners, pregnant women, patients with cognitive defects, and refugees, 2) unwillingness or 
inability to provide signed informed consent or participate in the study 3) unwillingness or inability to participate 
in home observation. 
 
Retention plan: Retention will be maximized by frequent involvement and contact with the research team and PD 
clinic staff. Patients undergoing peritoneal dialysis already require frequent clinic contact and daily management 
of their peritoneal dialysis making it less likely that they will “lose interest” or be non-compliant, and more likely 
to use a labor and time saving app. The research study will take place over 6 months, and most activities will take 
place as part of their usual clinic and home-based PD care. We also expect that the planned enhancements of the 
app and opportunity to contribute to their development, thereby making PD easier and safer for them and their 
family, will help promote retention.  
      Planned distribution of subjects by sex/gender, race, and ethnicity: We will not select or reject patients based on 
gender, race or ethnicity. The racial and ethnic composition of the general population, the PD patient population, 

8 
 
and the research study population is nearly exclusively Thai. The study will take place      at Srinagarind Hospital 
located in an area of exclusively Thai ethnicity. We expect nearly equal numbers of male and female enrollment 
given the nearly equal rates of PD between the sexes. We base this assumption on the reported prevalence of 
females on PD (50.8%) and males (49.2%) [8].  
 
Inclusion of children: We will enroll patients 18 years of age or older. The prevalence of PD in patients in Thailand 
under 18 years of age is <1% [8], therefore making it difficult to include this age group in our study. In addition, 
the etiologies of chronic kidney disease and co-morbidities are different in children and PD is used less frequently 
in children compared to hemodialysis.  
 
Collaborating sites: None  
 
 
Planned research procedures: Our process improvement project has 6 research procedures. 
1. Structured interviews using UTAUT: We will be collecting quantitative data from 10 participants using a 
structured interview questionnaire based on The Unified Theory of Acceptance and Use of Technology 
(UTAUT) model [32] to collect perceptions on user technology acceptance and usability. Each question 
is scored on a Likert scale and reported as a mean score for each question. We will use these results to 
assess opportunities to improve usability, facilitate user adoption and incentives to maintain use.  
2. Observation using CKD-PD in clinic: Research assistants will introduce the CKD-PD app to 10 
participants in the PD clinic, demonstrating its use and current features. This is will be following by 
observing participants use CKD-PD for the first time. During this observation, research assistants will 
follow an observation guide, which lists key tasks and features: 1). opening and accessing screens on 
CKD-PD app 2). using NFC to enter hydration metrics, 3). viewing hydration metrics, 4). identifying 
abnormal hydration metrics and follow up actions, 5). communication features to contact PD clinic staff, 
6) user incentives (e.g. LINE stickers). Users will also be prompted to “Think Aloud” as they go through 
each step to collect information about how they use the CKD-PD and identify steps which need to be 
improved through training or design modifications. They will also be asked what they “like and dislike” 
about each task and feature, and rate each feature as: 1= good, 2= neutral, 3= not good. Observation data 
will be collected by research assistants using handwritten notes and digital recorders. 
3. Observation using CKD-PD in participant homes: Research assistants will observe 5 users in their home 
(Group 1) while they set up and use the CKD-PD app for the first time, and again after subsequent CKD-
PD app revisions. They will use the same observation guide and process used during the in-clinic 

9 
 
observation, specifically looking for new issues arising in the home environment. They will ask what they 
“like and dislike” about each task and feature, and rate each feature as: 1= good, 2= neutral, 3= not good. 
Observation data will be collected by research assistant using handwritten notes. 
4. Collection of quantitative data regarding hydration parameters and data entry completion metrics from 
patients using the CKD-PD app:  We will collect quantitative data regarding the completion of hydration 
metric data using the CKD-PD app. This information is uploaded to the CKDNET database in the Thai 
Care Cloud, which is linked to patient identifiable data.  
5. Collection of PD clinic contacts: Information will be collected for each contact between the PD clinic 
staff and the participant. We will collect time and date, method of contact, who made the contact, reason 
for contact, outcome of contact. This will be collected in an electronic study log in the PD clinic. 
6. Validation of hydration metrics: During the second week of the implementation pilot, PD clinic staff will 
conduct a home visit for the 5 participants (Group 2). They will collect hydration metrics directly and 
compare with the results collected by the participant using CKD-PD. If there is a discrepancy, PD staff 
will review the hydration metric collection with the participant and check the equipment. After correcting 
any issues, they will conduct a repeat visit and repeat the process. 
Table 2: Summary of Process Improvement Project to Optimize Usability of the CKD-PD 
app 
 
Improvement Cycle #1 
1 month (N=10) 
Improvement Cycle #2 
1 month (N=5, Group 1) 
Improvement Cycle #3 
1 month (N=5, Group 1) 
Step 1: 
Collect data 
 
 
 
Objective 
- Introduce CKD-PD app 
- Test revised app for 1 
week  
-Test revised app again 1 
week 
Method 
- Structured interviews   
- In-clinic observation 
- “Think Aloud” in home 
testing 
- “Think Aloud” in home 
testing 
Metrics 
- Score on UTAUT   
  structured interview 
- Observation summary  
- Average feature rating 
- % completion of data 
entry  
- # & type of clinic 
contacts  
- Average feature rating 
- % completion of data 
entry  
- # & type of clinic 
contacts 
 

10 
 
Step 2: Identify improvement opportunities, determine app modifications, and training needs 
with team 
 
Step 3: Revise CKD-PD app and re-test 
Optimization 
goal 
Collect baseline rating of 
features 
- Average feature rating 
<2.5 
->70% data fields 
complete 
-Average feature rating 
<1.5 
->90% data fields 
complete 
Deliverable 
- Revised app 
- User training needs 
- Revised app 
- Draft user training 
materials  
- Final app revision 
- Final training guide & 
video  
 
 
Potential risks to participants All results will contain patient identifiable data. We believe this study will have low 
risk to participants with regard to physical, psychological, social, cultural or legal aspects. Potential risks exist 
due to loss of privacy and concern about change or access to PD care have been specifically identified. 
Technological problems may expose users to risk through failures of notification of the PD care team or patient 
of outlier results, misunderstood expectations, or unintended consequences. Strategies to mitigate these risks are 
discussed below. Alternative strategies available to participants are the option to decline or withdraw from the 
project at any time. 
      
Protection Against Risks 
Informed Consent and Assent 
Trained research staff will obtain informed consent from all participants. Dr. Sirirat Anutrakulchai and Dr. 
Wilaiphorn Thinkhamrop will oversee this process, including training of research staff and answering any 
questions from staff or participants as needed. The informed consent form and process will be approved by the 
Khon Kaen University Ethics Committee and the Partners Health     Care/Massachusetts General Hospital 
Institutional Review Board. All participants will be informed that their participation is voluntary and does not in 
any way impact access to treatment or other resources for care, and they can drop out of the study at any time for 
any reason. Signed copies of the informed consent will be kept with study records, and given to the participant. 
      
Planned strategies to minimize potential risks:  
We will include the following general protections: 

11 
 
1. De-identify and summarize results from questionnaires, observations, interviews, and the CKD-PD 
database when possible prior to sharing this information with the CKD-PD app process improvement 
team. 
2. Confirm all study staff successfully completed CITI ethics training  
3. Provide all written materials and descriptions of study activities in local language (Thai) at an appropriate 
literacy level. 
4. The CKD-PD app and validation of application from phase I study will be reported to the Khon Kaen 
University Ethics Committee before apply to participants in phase II study. 
We will obtain IRB approval for this proposed research through the Khon Kaen University Ethics Committee and 
the Partners Health     Care/Massachusetts General Hospital Institutional Review Board. We will not begin 
enrollment until this has been secured.  
 
We have identified these potential risks and have developed plans for mitigation. 
1. Loss of confidentiality and or privacy due to loss of data or hardware: Privacy and confidentiality loss 
may occur due to data breaches, physical loss or theft of computers, or carelessness of study personnel. 
We will minimize these threats by using password enabled and encrypted computers, de-identified data 
where possible, and research ethics training for study participants. The CKDNET and Thai Care Cloud 
has data safety features built in to its foundational structure including firewalls, encryption, and robust 
access restrictions.  
2. Loss of confidentiality and or privacy during home visit: We have identified additional potential privacy 
risk by conducting in-home user evaluations. Participants will also give specific consent for this activity 
during enrollment. 
3. Concern about impact on PD clinic access and care: Participants will be assured participation does not 
impact their ability to receive the same access and care in the PD clinic as non-participants. 
 
Plan for medical intervention 
In the event of unexpected/unplanned need for medical intervention, participants will be instructed to contact the 
PD clinic. Since all of the participants are currently patients managed in this clinic, they will be able to provide 
any necessary medical intervention in the clinic or through the emergency room which is the same access as study 
non-participants. During the in-home process improvement cycle and pilot implementation, it is possible that 
patients will have abnormal hydration metrics. The PD clinic staff will be monitoring this information during 
these trials and will provide clinical care as needed based on current standards of care. Participants will be 
provided with information to contact the PD clinic if needed.  

12 
 
 
Vulnerable Subjects 
  Our study does not involve special vulnerable populations such as fetuses, neonates, pregnant women, children, 
prisoners, institutionalized individuals. 
 
Potential Benefits of the Proposed Research to Research Participants and Others  
The objective of research is to improve the usability of the CKD-PD app for PD patients. The benefit of this 
research to participants is that the CKD-PD will be easier to use, incorporate features that bring benefit to PD 
patients, and potentially improve their health. Participants will also have the opportunity to contribute their ideas 
and experiences to this process, thereby helping the research staff understand the needs of PD patients Another 
benefit project is that patients can learn how and why they are valuable partners in research about mHealth 
technologies and how they can support the management of chronic diseases. Given the minimal risk involved in 
this study, the anticipated benefits presented are reasonable 
 
Importance of the Knowledge to be Gained  
The knowledge gained from this research is important for several reasons. First, optimizing the practical utility 
of this app in a real-world setting is essential before further research is conducted. Testing the various 
functionalities of the app such as the accuracy of PD metric collection, communication enhancements, patient 
self-monitoring, and monitoring of the outlier alert system are needed to make the app fulfill its potential. 
Understanding the limitations and unintended consequences of this technology is also of great value. We also 
hope to demonstrate how process improvement methodologies can be used in the development of mHealth 
interventions. If successful, we believe rapid-cycle process improvement methodologies can be an important tool 
to expedite and enhance the development of effective mHealth interventions.  
 
Aim 2: Conduct a randomized controlled trial to determine if using the CKD-PD app improves early 
treatment of overhydration by comparing the incidence of clinical interventions to treat overhydration in 
CKD-PD app users and non-users.  
 
Overview: We will conduct a randomized controlled trial (RCT) that will evaluate whether use of the CKD-PD 
app improves early treatment of OH by comparing the incidence of clinical interventions to treat OH in 
CKD-PD app users and non-users. Participants recruited from the PD clinics at Srinagarind Hospital, Khon 
Kaen Hospital, and Chaiyaphum Hospital will be randomized into two equal groups, one using the CKD-PD app 
(“app” group, N=100), and one receiving usual management (“no-app” group, N=100). Each group will collect 

13 
 
the same hydration metrics - blood pressure (BP), weight, and ultrafiltrate volumes - using home monitoring 
equipment (BP cuff, body weight scale, and hanging scale). The no-app group will manually enter the information 
into their “PD logbook”- the handwritten paper booklet which is usual care. In contrast, the app group will 
automatically collect and enter the same information into the CKD-PD app using NFC technology on their smart 
phone. It will be displayed in the CKD-PD app for the patient and uploaded to the CKDNET database in the Thai 
Care Cloud; it then can be view on the CKD-PD web application by the PD clinic staff. Patients will monitor their 
hydration status on a graphical display on their smartphone. PD clinic staff will be notified daily about “action 
required” alerts on the web application. For example, systolic BP greater than 140 mmHg, diastolic BP greater 
than 90 mmHg, weight gain greater than 3% based on dry weight, or ultrafiltrate volume < 500 milliliters will 
trigger a response from the PD clinic. Nephrologists will make clinical interventions to treat OH according to 
standard practice in Thailand, which include BP and diuretic medication adjustments, change in diet or fluid 
intake, dialysis prescription adjustments or referral for urgent clinical evaluation. Clinical interventions can occur 
at unscheduled patient contact (e.g. patient call) or scheduled patient contact (routine clinic visit) Our primary 
outcome measure will be the incidence of clinical interventions for OH, both routine and urgent, in 1 year from 
enrollment. Secondary outcome measures include OH related complications, hospitalizations and deaths, and will 
be collected from PD clinic and hospital records, and the CKDNET database.  
 
Setting and study population: The study will be conducted at the PD clinics at Srinagarind Hospital (N=100) the 
academic referral hospital affiliated      with Khon K     aen University, Khon Kaen Hospital (N=50) the 
government referral hospital for Khon Kaen province, and Chaiyaphum Hospital (N=50), the government referral 
hospital for the neighboring Chaiyaphum province in northeast Thailand. We will recruit 200 patients with end-
stage renal disease on PD from KKH to achieve a total sample size of 160.  
Inclusion criteria are  
-  patients with CKD from any cause on home based peritoneal dialysis 
-  age ≥18 
-  access to a smartphone capable of running the CKD-PD app 
-  ability of the patient or surrogate to demonstrate successful use of the CKD-PD app  
Exclusion criteria are 
- vulnerable populations  
- unwillingness to sign consent or participate in the study. 
 
Recruitment plan: The study population will be recruited from patients at the nephrology clinic at each of the 
participating hospitals who are undergoing peritoneal dialysis. Participants will be recruited over a 3-month period 

14 
 
at scheduled PD clinic appointments. This is feasible since all patients are seen within a 2-month interval. Accrual 
will be monitored by Thai study staff by recording enrolled participants in the electronic study log and a list of 
patients from KKH who declined enrollment or were excluded. Participants will be informed about the possibility 
of participating in a research study using a smartphone app to help collect information about the peritoneal 
dialysis, which they currently collect using a handwritten log book. They will be provided with written and verbal 
information about the research. All questions will be answered. Participation is completely voluntary, and 
participants can withdraw from the study at will. 
 
Retention plan: Retention will be maximized by frequent involvement and contact with the research team and PD 
clinic staff. Patients undergoing peritoneal dialysis already require frequent clinic contact and they have a long-
standing relationship with the MDs and RNs in the nephrology clinic. Compliance with PD clinic appointments 
is estimated at over 90%; participants who miss their scheduled appointments will be contacted by PD clinic and 
rescheduled.  
   Planned distribution of subjects by sex/gender, race, and ethnicity: We will not select or reject patients based on 
gender, race or ethnicity. The racial and ethnic composition of the general population, the PD patient population, 
and the research study population is nearly exclusively Thai. The study will take in place at Khon Kaen province     
, located in an area of nearly exclusively Thai ethnicity. We expect nearly equal numbers of male and female 
enrollment given the nearly equal rates of PD between the sexes. We base this assumption on the reported 
prevalence of females on PD (50.8%) and males (49.2%) [8].  
 
Inclusion of children: We will enroll patients 18 years of age or older. The prevalence of PD in patients in Thailand 
under 18 years of age is <1% [8], therefore making it difficult to include this age group in our study. In addition, 
the etiologies of chronic kidney disease and co-morbidities are different in children and PD is used less frequently 
in children compared to hemodialysis.  
 
Collaborating sites: None 
 
Statistical Design and Power: We determined our sample size by using the difference in incidence rates between 
two Poisson means with 25% precision. Data collected from Srinagarind Hospital indicate the intervention rate 
for OH, based on current practice of patients contacting the PD clinic staff with symptoms or concerns of OH 
outside of scheduled appointments, to be 4 times/week in 91 patients or a mean intervention rate of 2.3 
times/patient-year. Assuming a two-fold increase in the mean event rate for patients using the CKD-PD app or 

15 
 
4.6 times/patient-year in the CKD-PD app group, the desired sample size is 80 patients for each group, using a 
two-sided, large-samples z-test of the Poisson event-rate difference at a significance level of 0.05. Allowing for 
a 10% dropout rate, we will recruit a total of 200 patients (100 in each group). Our assumption that use of CKD-
PD app will result in a twofold increase in the incidence of clinical interventions is based on our preliminary 
experience with the 42 patients currently using the CKD-PD app. In those 42 patients, especially those with 
unstable fluid and blood pressure control, the app frequently identifies outlier measurements resulting in 
intervention opportunities which are not possible in the no-app control group.  
 
Baseline variables of the CKD-PD app and no-app groups will be described by summary statistics. Percent 
distribution will be presented for all categorical variables. Mean with its standard deviation and median 
(Minimum: Maximum) will be presented for continuous variables. The primary outcome will be assessed by 
comparing the difference between the CKD-PD app group (intervention) and the no-app group (control), in 
incident rate (or Poisson count) of intervention for OH. A linear mixed model with an identity link and a Poisson 
distribution will be performed. By this modeling, the incidence rate difference and its 95% confidence interval 
will be estimated to answer the primary research question. Estimations will be adjusted for effects of important 
covariates that are imbalanced at baseline. Effect size will be calculated for secondary outcomes. All analyses 
will be performed using STATA version 14 (StataCorp, College Station, TX), using a significance level of 0.05. 
All statistical tests will be two-sided.  
 
Randomization 
Participants (Srinagarind N=100, Khon Kaen N=50, Chaiyaphum N=50) will be randomized into two equal 
groups at each site, one using the CKD-PD app (app group, N=50/25/25), and one receiving usual management 
(no-app group, N=50/25/25), using 4-block computer randomization in STATA. They will be assigned a PD clinic 
visit day based on their randomization allocation to reduce contamination or cross talk between the 2 study groups.  
 
Delivery of intervention  
Definition of study intervention:  
Our study intervention is defined as the CKD-PD app, home hydration metric measurement equipment, and the 
monitoring of the uploaded hydration metrics to the CKDNET database. 
 
Collection of hydration metrics: After enrollment, participants in both groups will undergo training on how to 
collect daily hydration metrics: body weight, blood pressure, and dialysate inflow and outflow volumes for each 
cycle. The app group will receive training on how to enter hydration metrics using NFC on the CKD-PD app, in 

16 
 
addition to training on how to use other features on the CKD-PD app including self-monitoring of hydration 
metrics and in-app communication with PD staff. The no-app group will receive instructions on how to record 
the same information in their paper PD log book as well as information about how to contact the clinic by phone. 
Research staff will also make a home visit for app-group participants at the start of data collection to confirm 
correct equipment set up and use. 
 
Clinical interventions: In both the app and no-app groups, clinical interventions for OH can occur at either an 
unscheduled patient contact (e.g. phone call, clinic visit, or emergency visit) or at a scheduled clinic visit. In the 
app group, clinical interventions can also occur when an action required notification occurs, and the PD clinic 
staff contacts the patients and determines that a change in treatment is indicated to manage the OH. This occurs 
when a patient is flagged as an outlier (action required) because one or more of the hydration metrics is outside 
of the established acceptable range (see paragraph directly below). The PD clinic staff, after reviewing the 
patient’s hydration metrics, will initiate contact with the patient, to review hydration metrics and patient 
symptoms. If the PD nurse confirms abnormal hydration metrics (action required) or clinical symptoms consistent 
with OH, the case will then be referred to the nephrologist to review the information and determine the need for 
a clinical intervention. Nephrologists will make clinical interventions according to standard practice in Thailand, 
summarized as guidelines and provided to nephrologists and PD clinic staff for reference at the beginning of the 
study. An episode of clinical intervention is defined as treatment intervention for abnormal hydration metrics or 
clinical symptoms of OH with 1 or more changes in patient management: change in medications, dialysis 
prescription, fluid or salt restriction, or urgent clinic/hospital visit. A contact that results in no change in 
management is not considered a clinical intervention for OH.  
 
Monitoring CKD-PD smartphone and web applications: We will set 3 categories to be used by PD clinic staff 
when monitoring hydration metrics on the CKD - PD web application: normal, monitor, and action required. 
Based on criteria specified by KKU nephrologists, deviations in weight of >3% from baseline dry weight, 
BP>140/90, and ultrafiltration volume of <500 ml will be used as baseline parameters for triggering an outlier 
alert for action required, indicating that the patient’s hydration metrics need to be reviewed. We will also set 
critical values for hydration metrics, which require patient to go directly to the emergency department. We expect 
that some patients will require different parameters for triggering an outlier alert. In order to address this issue, a 
study nephrologist will provide normal and action required values for weight, blood pressure, and ultrafiltration 
volumes for each patient, at the time of enrollment after reviewing previous values from their PD logbook. During 
the study, the patient’s nephrologist will have the option to modify the notification parameters. Hydration metric 
values between normal and action required will be categorized as monitor status.  

17 
 
 
PD clinic staff nurses will receive a list of patients with action required alerts once a day. They will review the 
hydration metrics and contact the patient(s), ask about symptoms, and have the nephrologist review the data and 
case to determine need for clinical intervention.  
 
PD patients will also have the ability to self-monitor using the visual display of hydration metrics on the CKD-
PD app. Planned features to simplify patients understanding of their fluid status include color coded zones 
corresponding to the normal (green), monitor (yellow), and action required (red) categories. During training, 
patients will be instructed to contact the PD clinic if one or more of the hydration metrics indicate action required. 
 
Planned research procedures: Our project has 5 research procedures, all of which will collect private, identifiable 
patient information.  
1. Monitoring for abnormal hydration metrics by PD clinic staff: PD clinic staff will review the CKD-PD 
web application daily for outlier alerts. Outliers are determined based on the hydration metric parameters 
set by the nephrologist at enrollment. See 4.2.a.3 below.  
2. Clinical intervention for overhydration: Change in medical treatment in response to OH detected by 
clinical symptoms or hydration metrics. Interventions may include a change in medications to treat OH 
such as anti-hypertensives or diuretics, dialysis prescription, dietary sodium/fluid restriction, referral for 
evaluation in clinic, or hospitalization. This information will be collected in the electronic PD clinic study 
log at the time of the clinical intervention. 
3. Unscheduled clinic contacts: When patients in either group make an unscheduled contact with the PD 
clinic this will be recorded in the PD clinic electronic study log. Unscheduled clinic contact can also occur 
in the “app” group when PD clinic staff contact a patient in response to abnormal hydration metrics. 
Unscheduled contacts include any phone call, text, social media, or web app message, and unscheduled 
visit to the PD clinic or emergency department. The information collected included patient name/MR#, 
reason for contact, mode of contact, who initiated contact, date and time of day, and action taken. 
Unscheduled clinical interventions will be recorded at the time of the event.  
4. Scheduled clinic contacts: Patients in both groups will have regularly scheduled clinic visits, typically 
bimonthly. Clinical interventions for OH made during this visit will be recorded in the electronic PD clinic 
study log. A medical record review will also occur at each visit to collect any other hospitalizations, 
complications, or clinical interventions that may have occurred in the interim. 
5. CKDNET database review: In order to ensure all events have been captured, we will review the CKDNET 
database, which has all inpatient and outpatient visits, on a bimonthly basis. 

18 
 
 
Data collection overview  
Data elements for analysis of covariates at enrollment:  These will include: age, sex, educational level, cause of 
CKD, eGFR,  co-morbidities (e.g. diabetes, hypertension, albumin level), previous hospitalizations for OH, 
smoking status, distance from clinic, months on PD, months of CKD-PD usage, and app user type (patient or 
surrogate). The source will be medical records and patient interview at time of enrollment.  
Clinical interventions used: We will record the type of clinical intervention, patient symptom/hydration metric 
abnormality, whether it was occurred from a scheduled or unscheduled communication, and ordering clinician. 
This information will be recorded in an electronic study log at time of PD clinic visit, or time of communication 
to patients.  
Outcome measures: Our primary outcome measure will be the incidence of clinical interventions for OH in 1 year 
from enrollment. Secondary outcome measures include OH-related complications  
Drop out/Lost to follow up: The number of patients who drop out, are lost to follow up or died during the study 
period will be collected. This information will be collected from chart reviews and PD clinic communications and 
recorded in the electronic clinic study log.  
PD clinic/patient communications: We will also collect data about communications between PD clinic staff 
patients or their surrogates by logging phone calls and messaging app contacts.  This information will include 
who initiated the call, whether or not is resulted in a clinical intervention, the type of clinical issue, and mode of 
communication. This information will be recorded in the PD clinic electronic study.  
 
Potential risks to participants: This study poses low risk to participants with regard to physical, psychological, 
social, cultural or legal aspects as both groups receive the same standard of care as currently provided to PD 
patients at the study site nephrology clinics, including routine clinic appointments, medications, dialysis 
prescriptions, dietary recommendations, educational and other community support networks, and urgent services 
e.g. phone contact to PD clinic, unscheduled clinic visits, and emergency care. We have identified some potential 
specific risks including data breaches, lost or malicious hacking of computers, loss of privacy, concern about 
change or access to PD care, over or under identification of overhydration, failure to detect life threatening outlier 
data points in a timely fashion, technology failure, communication failures and errors, and unintended 
consequences of using a new technology. Strategies to mitigate these risks are discussed below. Alternative 
strategies available to participants are the option to decline or withdraw from the research at any time. 
 
Informed Consent and Assent  

19 
 
Informed consent: Trained research staff will obtain informed consent from all participants. Dr. Sirirat 
Anutrakulchai and Dr. Wilaiphorn Thinkhamrop will oversee this process, including training of research staff and 
answering any questions from staff or participants as needed. The informed consent form and process will be 
approved by the Khon Kaen University Ethics Committee and the Partners Health Care/Massachusetts General 
Hospital Institutional Review Board. All participants will be informed that their participation is voluntary and 
does not in any way impact access to treatment or other resources for care, and they can drop out of the study at 
any time for any reason at all including no reason. Signed copies of the informed consent will be kept with study 
records, and a copy will be given to the participant. 
 
Planned strategies to minimize potential risks: We will include the following general protections: 
1. De-identify and summarize results from study logs and medical records prior to analysis when feasible. 
2. Confirm all study staff successfully completed CITI ethics training. 
3. Provide all written materials and descriptions of study activities in local language (Thai) at an appropriate 
literacy level.  
4. We will obtain IRB approval for this proposed research through the Khon Kaen University Ethics 
Committee and the Partners Health Care/Massachusetts General Hospital Institutional Review Board. We 
will not begin enrollment until this has been secured.  
5. We will use password protected, encrypted computers. 
6. Access to study data will be limited to research team members 
 
We have identified these specific potential risks to patient and surrogate participants and have developed plans 
for mitigation. 
1. Concern that access to PD staff and urgent services will change because of research. We will assure all 
participants that patients in both groups will have the same access to PD clinic staff for questions or 
concerns, same as in current practice. 
2. CKD-PD app may not identify overhydration as anticipated. We will advise patients that they still need 
to keep all the usual scheduled PD clinic appointments, so participants receive the current standard of 
care.  
3. We anticipate that CKD-PD app users will receive increased number of clinical interventions as a result 
of increased monitoring. We believe this result will improve effectiveness and quality of care, however 
there is always inherent risk in any clinical intervention even if the benefits are determined to outweigh 
them. All clinical decisions will be made by the same providers already caring for the patients, according 
to the usual standard of care. Study clinicians will receive training for interpreting CKD-PD app data 

20 
 
which includes a summary of the local standard of practice, assessing the whole clinical picture, and 
looking at data trends rather than single isolated readings. 
4. CKD-PD app users may introduce new source of potential error by incorrect data entry. Patient or 
surrogate will be given training in proper data entry techniques and observed in their homes to make sure 
they can use app correctly.  
5. Failure of technology (loss of network connection, malfunction of smart phone) could result in 
unanticipated delay or loss of data for CKD-PD app users. We will provide participants in the CKD-PD 
app group with directions on how to respond to failure of technology. This includes resuming use of the 
PD logbook and how to notify study staff in the event of technology failure or question on correct use of 
CKD-PD. This inadvertent data loss is similar to a lost log book in the control group.  
6. CKD-PD app users are at risk for potential unexpected or unintended consequences of introducing a new 
process or technology. Study staff will be monitoring the use of CKD-PD, looking for potential issues or 
problems that were unexpected or unanticipated throughout the study including mismatched expectations 
among MDs, RNs, and patients.  
7. Loss of confidentiality and or privacy due to loss of data or hardware. Privacy and confidentiality loss 
may occur due to data breaches, physical loss or theft of computers, or carelessness of study personnel. 
We will minimize these threats by using password enabled and encrypted computers, de-identified data 
where possible, and research ethics training for study participants. The CKDNET and Thai Care Cloud 
has data safety features built in to its foundational structure including firewalls, encryption, and access 
restrictions.  
8. Failure to react to life threatening data elements in a timely fashion. Patients will be informed that the PD 
clinic will only check PD metrics once a day and be available for calls from patients according the usual 
practice. We will advise patients that if they detect PD metrics in the action required range or have any 
concerning symptoms, and are unable to contact the PD clinic, they should proceed as standard practice 
for PD patients or go to the emergency department.  
 
Plan for medical intervention  
In the event of unexpected need for medical intervention, patients will be instructed to contact the PD clinic or 
emergency room depending on the circumstances. Since all of the participants are currently patients managed in 
this clinic and in this tertiary care hospital, they will be able to provide any necessary medical intervention. 
Patients and family members will receive information on how to obtain emergency care during off hours for 
clinical concerns and critical values of hydration metrics e.g. BP >200/120, BP< 80/40 during the enrollment, in 
accordance to the usual practice at the PD clinic. 

21 
 
 
Vulnerable Subjects 
  Our study does not involve special vulnerable populations such as fetuses, neonates, pregnant women, children, 
prisoners, institutionalized individuals. 
 
Potential Benefits of the Proposed Research to Research Participants and Others  
The objective of this research is to improve early treatment of OH thereby decreasing complications and 
hospitalizations. If our hypothesis is true, this is a potential benefit to CKD-PD app users. It will also support 
further efforts to develop and scale up use of CKD-PD app thereby benefiting many more individuals. Patients 
benefit from accurate and timely monitoring of hydration status as it increases opportunity for meaningful and 
early intervention. The CKD-PD app also aims to improve patient engagement in self-management of PD by 
providing a graphical display of PD monitoring metrics similar to a dashboard with trends and current status 
displays. Patients and their surrogates can gain insight about their own health status and learn how they can work 
more efficiently with the PD care team to manage their PD and hydration status. Given the minimal risk involved 
in this study, the anticipated benefits presented are reasonable. 
 
Importance of the Knowledge to be Gained  
The knowledge gained from this research is important for several reasons. First, determining whether or not using 
the CKD-PD app can result in earlier treatment for OH is important before scaling up the intervention to a larger 
population. Second, the information gained from this research is important preliminary information in order to 
conduct the research of greatest interest – whether or not use of the CKD-PD app can reduce complications and 
hospitalizations and decrease mortality for PD patients. If proven successful, this can meaningfully impact the 
lives of thousands of PD patients and potentially reduce costs. Third, this research will also provide information 
about whether or not PD patients can successfully self-monitor their hydration status, which is valuable 
knowledge affecting further implementation of the CKD-PD app to a larger population. Fourth, it will also provide 
the opportunity to link patient collected mobile health data with hospital and clinic records to provide a rich multi-
modal database for predictive analytics. Considering these benefits to individual participants and other PD 
patients, the risks are reasonable 
 
Monitoring and Quality Assurance  
Our project measures the impact of the CKD-app on managing OH. Our intervention is the use of the app, not a 
specific medication or treatment and all participants will receive the same clinical interventions based on the same 
usual standard of practice. Therefore, we feel there is low risk to patients as the care and treatment of patients is 

22 
 
standardized- the difference is the timeliness of the interventions. Because our research will introduce a 
technology that can impact the frequency of clinical interventions and the quality of data used to manage patients, 
we have outlined several ways to reduce or manage the potential risks. In addition, we will take the following 
steps to ensure safety. 
1. Develop guidelines for PD clinic staff regarding the process of monitoring and response to the daily outlier 
alerts generated by the CKD-PD web application, and communications from patients or surrogates. These 
guidelines will provide details on the daily review of hydration metric alerts for “action required”, action 
steps to be taken (e.g. contact patient, review with nephrologist), recording in study log.  
2. Provide a summary of guidelines for managing OH in the study site nephrology clinics based on Thai 
standards of care to serve as a reference and promote consistency of clinical interventions nephrologists 
and PD nurses. 
3. Develop a process for case review by study investigators (nephrologists) for unexpected complications or 
hospitalizations, and unexpected increase /decrease in clinical interventions for OH.  
4. Dr. Sirirat Anutrakulchai and Dr. Wilaiphorn Thinkhamrop will be primarily responsible for oversight of 
the research activities and data collected at Srinagarind Hospital, Khon Kaen Hospital and      Chaiyaphum 
Hospital. The consortium steering committee comprised of Drs. Katharine Morley, Sirirat Anutrakulchai, 
Michael Morley, and Wilaiphorn Thinkhamrop will also serve as a data safety monitoring committee and 
will monitor data during collection for safety signals such as increased complications or mortality in either 
study groups or other indications of potential concerns. They will be in frequent contact throughout the 
study via email, video calls, in addition to scheduled site visits. All serious adverse events will be reported 
to the Srinagarind Hospital/Khon Kaen University Ethics Review Committee and Partners/MGH IRB 
according to their requirements. Data collection and study activities will be suspended until appropriate 
precautions have been taken to address or avoid repeat safety concerns 
5. We will register with clinicaltrials.gov. 
 
 
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Information and Consent for Research Study Volunteer 
  
                  Research project name: Experimental study comparing use of CKD-PD mobile app in patients 
undergoing peritoneal dialysis with those not using the CKD-PD app to detect excess fluid 
accumulation 
 
Principle researcher: Associate Professor Dr. Sirirat Anutrakulchai (Thailand) 
                  Principle researcher:  Katharine Morley, MD MPH (USA) 
                   Funding source:    National Institutes of Health (NIH) 
Introduction 
Thailand has many patients with end stage renal disease that require peritoneal dialysis to clear 
waste products and excess fluid from their body because their kidneys do not function properly. 
Patients on peritoneal dialysis have to collect information every day including blood pressure, 
body weight and the amount of fluid removed during dialysis. This information helps the kidney 
doctor make sure patients have good fluid balance. It is important to maintain good fluid balance 
to reduce complications that can occur in peritoneal dialysis patients, such as high blood 
pressure, accumulation of fluid on the lungs, infections, heart attack, and strokes. These 
complications can result in hospitalizations, decreased quality of life, and sometimes death.   
 
A team from Khon Kaen University including kidney specialists, computer engineers and public 
health researchers developed a mobile phone application to help peritoneal dialysis patients 
collect information that is needed by the kidney doctors to help make sure that they maintain 
good fluid balance. It is called the “CKD-PD app”. Peritoneal dialysis patients can use it to 
collect blood pressure, body weight and the amount of fluid removed during dialysis. This 
information is sent the kidney clinic where it can be checked by the kidney doctors and nurses. 
The app will also allow patients to monitor their own fluid status. The goal is to find patients who 
are accumulating too much fluid sooner so the kidney doctors can make adjustments in their 
treatment earlier, and hopefully decrease complications, improve quality of life for patients, and 
decrease health care costs. 
 
This research project intends to study how the CKD-PD app with basic home monitoring 
equipment can improve care for peritoneal dialysis patients through earlier detection of excess 
fluid accumulation. The research will evaluate if of CKD-PD app with home monitoring 
equipment allows nephrologists to make changes in medications, dialysis and diet. It will also 
collect information to see if complications related to too much fluid retention are decreased.   
 
Research objective: To compare the number of treatments for fluid accumulation (changes to 
medication, dialysis prescription and diet) in patients using the CKD-PD app with home monitoring 
equipment with patients not using the CKD-PD app.  
 

Participation in your research project is voluntary. 
You are invited to participate in this research study about using the CKD-PD app to improve 
early detection of excess fluid accumulation in peritoneal dialysis patients compared with 
patients not using the app. Before you agree to participate in the research project, you need to 
know the risks and benefits of participating in the research, so you can make an informed 
decision. This process is called "consent to participate in research studies".  
 
You will be given consent documents in order to provide you with information about participating 
in the research. They will explain why you might want to join the research, what happens during 
the research, and the risks and benefits of participating in the research. Please read this 
information carefully. If you have any questions, you may consult with one of the research staff, 
your doctor, or any other person you want. After learning about the details of the research, you 
will be asked to sign this consent document to confirm your participation in the research. It is 
your choice whether or not you want to participate. Your decision does not change the medical 
care you receive now or in the future. You can agree to take part in the research now and 
change your mind at any time and drop out later. You do not need to provide a reason if you 
chose not to participate or to drop out. 
  
The purpose of this research 
You are invited to participate in this research because you are receiving treatment for kidney 
disease with peritoneal dialysis, and you or your caretaker can use the CKD-PD app on your 
mobile phone. This research will compare the number of treatments for fluid accumulation 
(changes to medication, dialysis prescription and diet) in patients using the CKD-PD app with 
home monitoring equipment with patients not using the CKD-PD app. It will also compare the 
number of complications and hospitalizations in each group. A total of 200 patients on peritoneal 
dialysis from Srinagarind Hospital, Khon Kaen Hospital and Chaiyaphum Hospital will 
participate. They will be randomly assigned to 2 groups with 100 patients in each group. One 
group will use the CKD-PD app and home monitoring equipment and the other group will not 
use the app. The group not using the app will follow the usual process of performing peritoneal 
dialysis and record their information about blood pressure, body weight and amount of dialysis 
fluid removed in a notebook. 
                What you will do if you participate in this research  
If you decide to participate in this research and sign the consent form, you will be assigned to the 
group using the CKD-PD app or the group not using the CKD-PD app. The process of assigning 
you to a group is done randomly. You will have an equal chance (50%) of being assigned to either 
group. If you are assigned to the app user group, you will be asked to install the CKD-PD app on 
your mobile phone and participate in training on how to use the app and the equipment. If you are 
assigned to the group not using the CKD-PD app, you will not do anything different that the usual 
way you collect information about blood pressure, body weight and amount of dialysis fluid 
removed and record it in your notebook.   
Participants in both groups will be asked to come to the kidney clinic every 2 months over 1 year. 
Your appointment with the kidney clinic doctor and/or nurse will be the same as usual. You will 
be asked to spend about 10 extra minutes in the clinic to speak with the research staff.  

Enrollment process 
The enrollment process will be done before you are assigned to be in the CKD-PD app user 
group, and the usual care (no app) group. One of the research assistants will do the following 
steps in the enrollment process.  
• 
Review the consent form, answer any questions and then ask you to sign the consent.  
• 
Confirm that your smartphone or smartphone of you caregiver can run the CKD-PD app. 
• 
Collect basic information about you such as age and gender 
• 
Review your medical history and health habits such as use of alcohol and smoking 
• 
Perform a complete physical examination, including skin, eyes, ears, lungs, heart, 
abdomen, limbs and nervous system 
• 
Measure height, weight, body temperature, body surface area, blood pressure and heart 
rate. 
• 
Review all medications you are taking, including medications that you take without a 
doctor’s prescription 
 
Training after enrollment 
Participants in each group will attend an educational session.  If you are assigned to the CKD-PD 
app user group, you will either receive training on how to use the CKD-PD app and home 
monitoring equipment. If you are assigned to the non-app user group, you will receive a review of 
recording information in your notebook. 
 
Follow up appointments  
You will have a follow up appointment at the kidney clinic once every 2 months, just like you 
normally do. During this appointment the research staff will meet with you about the app or your 
notebook.  
 
Termination of resear 
During the research you will continue to receive treatment with peritoneal dialysis as prescribed 
by your doctor. Your treatment will continue as long as you benefit from it and you tolerate it. If 
you develop too many side effects, become pregnant, no longer benefit from the treatment or 
are no longer able to tolerate the treatment, you can discuss terminating treatment with your 
doctor. If you no longer continue peritoneal dialysis, the research team will discuss stopping use 
of the CKD-PD app. If your disease worsens while you are participating in the research and your 
doctor has evidence to believe that you will receive clinical benefits from continuing to use the 
app, you will be advised of this information.   
 
Withdrawing consent and exiting the research study 
You can decide to stop participating in the research at any time, without providing a reason.  
You can withdraw your consent to participate in the research project at any time, including 
asking the research staff to no longer contact you or contacting you at the clinic. You can 
withdraw your consent to allow research staff to analyze any of the data already collected. 
If you want to stop participating in the research, you will receive an appointment to meet with the 
research team about stopping the research. After discontinuing use of the app, you should 
resume treatment plan prescribed by your doctor.  If you are in the CKD-PD app group, you will 

be asked to resume using the notebook to record your peritoneal dialysis information.  Your 
medical care will not be affected by leaving the research study.  
 
Risk and discomfort that may occur 
Using the app or your notebook to record your blood pressure, body weight and the amount of 
dialysis fluid removed while doing peritoneal dialysis does not cause any risk or discomfort. The 
only discomfort you may experience is the pressure of the arm cuff which causes pressure on 
your arm when inflated. These are measurement that you are already taking because you are 
on peritoneal dialysis. You can record your blood pressure, body weight and the amount of 
dialysis fluid removed in the app yourself or with the help of your caregiver.  
 
Benefits of participating in research projects 
You will receive your usual medical care during the study. You may not benefit directly from 
participating in this study. The information from this research study may help you and /or other 
chronic kidney disease patients who are treated with peritoneal dialysis. The information from 
your participation in the study will help to determine if the CKD-PD app can help decrease too 
much fluid accumulation in patients on peritoneal dialysis.  
  
Compensation for participating in this research 
If you agree to volunteer for this research study, the research will be performed when you visit 
the kidney clinic for your usual appointment. You also may be asked to come to the kidney clinic 
for additional visits if needed.  
  
Compensation for injury cases resulting from research 
If you become ill or injured as a result of participating in this study, the research staff will help 
you obtain medical care at your hospital. This care will be provided according to established 
medical standards.  
 
Confidentiality and permission to collect, use and disclose personal medical information 
Your personal identifying information, such as name and birthday, will be protected during this 
study. Research staff, including doctors and nurses, and clinical research organizations such as 
the US Food and Drug Administration and European Medical Office Inspectors that have been 
authorized to see this information have received research ethics and confidentiality training. The 
personal information collected during this study includes information from your medical records. 
which is necessary to ensure the accuracy and reliability of the research. The research staff 
may contact your doctor, in order to collect additional medical information history.  
During this study your name will be replaced by a unique code to identify you. The data 
obtained from you during the research will be linked with this code. The research team may 
disclose your information to other groups or individuals working with the research team. Anyone 
receiving this information is required to work within the scope of this consent, as determined by 
the Ethics Review Committee.  

This clinical research project is being done by a collaboration of medical researchers. In the 
future, rights to the information collected in this research may be forwarded to new sponsors or 
other agencies. This may include the code to the personal identifying and medical information. 
The identification code and research data collected from you in this research study will be 
integrated into the secure electronic research system of the research team of physicians These 
systems are managed and monitored by a team of physicians. You have the right to check your 
medical information in the records. You have the right to request changes in the medical 
information if you believe it is incorrect. However, please note that access to medical 
information may be restricted during the study if necessary, to maintain the integrity of the 
research. You will have access to medical information stored by the researchers when the 
research study ends. 
 
                  Who you should contact if you have questions or concerns 
 
●   If you have questions about research, please contact       
Prof. Dr. Sirirat Anutrakulchai, Srinagarind Hospital Kidney Clinic, Department of 
Medicine. Faculty of Medicine Khon Kaen University Phone number 043 - 36x - xxx (in office 
hours) or 0xx - xxx - xxxx (outside office hours) 
 
●    If you have questions about your rights as a research volunteer, please contact      
      Office of the Human Research Ethics Committee, Khon Kaen University (Sub-Branch) 
       Room 5317, 3rd Floor, Vejjajakarn Building, Faculty of Medicine, Khon Kaen University,  
      Tel. 08 - 9714 - 1913 number within 67133 - 4       
 
Volunteer consent for the research project 
I (Mr., Mrs., Ms.) …. ………… .. …………………… ...…. Last name …………. 
……………………. Age ……………. year At home number ………. ……… .. group…. …… .. 
district ……. ………………… district ……… .............. Province ........................ ... .... have 
received an explanation from .................................................................................. ....... (Name of 
contributor) about volunteering in a medical research project to study how the CKD-PD app with 
basic home monitoring equipment can improve care for peritoneal dialysis patients through 
earlier detection of excess fluid accumulation. The research will evaluate if of CKD-PD app with 
home monitoring equipment allows nephrologists to make changes in medications, dialysis and 
diet. It will also collect information to see if complications related to too much fluid retention are 
decreased. 
 
I have read this document or have had the contents of this document explained to me. I 
understand the purpose of this research and what will happen to me in this study. I consent to 
participate in this study independently. According to the details given to me in this document I 
will receive a copy of this document as signed below. I agree to contact the doctor or clinic staff 
if I experience any problems or side effects during the research study. 
 

By signing this consent document I am allowed the research staff to use, access and share my 
personal medical information as specified in the topic "Confidentiality and the permission to 
collect, use, and disclose personal medical information" .This consent document is valid under 
the law, unless I revoke my consent. 
  
Note:  
 (1) The medical practitioner must not be a volunteer applicant.  But can provide information / 
explanation 
(2) In the event that the volunteer is unable to read or Read / sign, use the following finger 
stamp 
 
 
CKDPD version 1. 0: Date 20 March 2019 Page 1 of 11                              
  
I cannot read, but the researcher has presented the text in this consent form to me orally in my own 
language that I can understand. I therefore stamped my right finger in this consent form with willingness. 
 
Name and Signature of the person who explained consent 
 
____________________________________ 
 
Witness name and signature 
 
________________________________________ 
(The witness must not be a doctor or researcher) 
 
Right hand stamped date / month / year ______________________________