Skip to content

Improving Care for Peritoneal Dialysis Patients With the CKD-PD App

Improving Care for Peritoneal Dialysis Patients With the CKD-PD App

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04797195
Enrollment
208
Registered
2021-03-15
Start date
2021-12-13
Completion date
2023-04-30
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic, Peritoneal Dialysis Complication

Keywords

mobile health, peritoneal dialysis

Brief summary

Managing the hydration status in patients undergoing peritoneal dialysis (PD) is a key task for nephrologists in Thailand that is made difficult due to lack of timely access to hydration metrics including weight, blood pressure, and ultrafiltration volume. This research project aims to improve the monitoring of hydration status in PD patients from a bimonthly, in-clinic review of a handwritten log-book to a smart phone based app (CKD-PD) with digitized data that allows for near real time monitoring hydration abnormalities, thereby creating the opportunity for earlier treatment of overhydration. The investigators hypothesize that use of the CKD-PD will improve early treatment of overhydration, and potentially reduce the incidence of complications, hospitalizations, and mortality in PD patients.

Detailed description

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. This 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 smart phone 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 to transferred to the CKD-PD app. Hydration metrics are uploaded to CKDNET (Chronic Kidney Disease NorthEast Thailand) database in the Thai Care Cloud - Thailand's national health database, merging patient collected data with hospital and clinic records. The objective of this study is to determine if use of the CKD-PD app can improve early treatment of overhydration in PD patients. The investigators will conduct a randomized clinical trial comparing the incidence of clinical interventions for treatment of overhydration. PD patients from 3 facilities in Northeast Thailand - Srinagarind Hospital at Khon Kaen University, Khon Kaen Hospital and Chaiyaphum Hospital - (N=200) will be randomized into two groups - one using the CKD-PD app, and one receiving usual management. The primary outcome will be the incidence of clinical intervention to treat overhydration as an intermediate outcome related to the secondary outcomes: complications, hospitalizations, and mortality related to fluid overload.

Interventions

OTHERCKD-PD app with home monitoring equipment

use home monitoring equipment to measure blood pressure, body weight, and dialysate fluid volume and record in CKD-PD app

Sponsors

Khon Kaen University
CollaboratorOTHER
Fogarty International Center of the National Institute of Health
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* chronic kidney disease from any cause on home based peritoneal dialysis * age greater than 18 years * access to a smart phone capable of running the CKD-PD app

Exclusion criteria

* vulnerable populations including children, prisoners, pregnant women, individuals with cognitive impairment, refugees * unwillingness to sign consent or participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Clinical Interventions for Over Hydrationthrough study completion, average 1 yearChange in treatment in response to over hydration detected by clinical symptoms or abnormal hydration metrics. Includes change in antihypertensive or diuretic medications, change in dialysis prescription, fluid/salt dietary change, referral to clinic for evaluation or hospitalization

Secondary

MeasureTime frameDescription
Complication of Over Hydration Requiring Hospitalizationthrough study completion, average 1 yearClinical event due to over hydration requiring hospitalization. Includes volume overload, infections, peritonitis, major adverse cardiac event, severe hypertension or stroke
Technique Failurethrough study completion, average 1 yearInability to continue peritoneal dialysis for any reason requiring a change to hemodialysis
Mortalitythrough study completion, average 1 yearDeaths occuring during study period for any cause

Other

MeasureTime frameDescription
Clinic Contactsthrough study completion, average 1 yearCommunication by phone or messaging app between peritoneal dialysis patients or surrogate regarding clinical concern about symptoms or hydration metrics

Countries

Thailand

Participant flow

Participants by arm

ArmCount
CKD-PD App User Group
Patients on peritoneal dialysis using the CKD-PD app and home monitoring equipment to measure and record blood pressure, body weight, and dialysis fluid removed CKD-PD app with home monitoring equipment: use home monitoring equipment to measure blood pressure, body weight, and dialysate fluid volume and record in CKD-PD app
103
Usual Care Group
Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method
105
Total208

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyChange from PD1515
Overall StudyDeath815
Overall StudyWithdrawal by Subject32

Baseline characteristics

CharacteristicCKD-PD App User GroupUsual Care GroupTotal
Age, Continuous53.9 years
STANDARD_DEVIATION 15.5
54.8 years
STANDARD_DEVIATION 14.8
54.3 years
STANDARD_DEVIATION 15
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
103 Participants105 Participants208 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Hospital
Chaiyaphum
48 Participants48 Participants96 Participants
Hospital
Khon Kaen
35 Participants37 Participants72 Participants
Hospital
Srinagarind
20 Participants20 Participants40 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
103 Participants105 Participants208 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Thailand
103 participants105 participants208 participants
Sex: Female, Male
Female
63 Participants54 Participants117 Participants
Sex: Female, Male
Male
40 Participants51 Participants91 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
8 / 10315 / 105
other
Total, other adverse events
0 / 1030 / 105
serious
Total, serious adverse events
54 / 10375 / 105

Outcome results

Primary

Clinical Interventions for Over Hydration

Change in treatment in response to over hydration detected by clinical symptoms or abnormal hydration metrics. Includes change in antihypertensive or diuretic medications, change in dialysis prescription, fluid/salt dietary change, referral to clinic for evaluation or hospitalization

Time frame: through study completion, average 1 year

ArmMeasureValue (NUMBER)
CKD-PD App User GroupClinical Interventions for Over Hydration473 clinical interventions
Usual Care GroupClinical Interventions for Over Hydration164 clinical interventions
Secondary

Complication of Over Hydration Requiring Hospitalization

Clinical event due to over hydration requiring hospitalization. Includes volume overload, infections, peritonitis, major adverse cardiac event, severe hypertension or stroke

Time frame: through study completion, average 1 year

ArmMeasureValue (NUMBER)
CKD-PD App User GroupComplication of Over Hydration Requiring Hospitalization67 events
Usual Care GroupComplication of Over Hydration Requiring Hospitalization113 events
Secondary

Mortality

Deaths occuring during study period for any cause

Time frame: through study completion, average 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CKD-PD App User GroupMortality8 Participants
Usual Care GroupMortality15 Participants
Secondary

Technique Failure

Inability to continue peritoneal dialysis for any reason requiring a change to hemodialysis

Time frame: through study completion, average 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CKD-PD App User GroupTechnique Failure14 Participants
Usual Care GroupTechnique Failure15 Participants
Other Pre-specified

Clinic Contacts

Communication by phone or messaging app between peritoneal dialysis patients or surrogate regarding clinical concern about symptoms or hydration metrics

Time frame: through study completion, average 1 year

ArmMeasureValue (NUMBER)
CKD-PD App User GroupClinic Contacts473 events
Usual Care GroupClinic Contacts164 events

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026