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

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797195
• Other study ID #: 2018A013145
• Status: Completed
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Peritoneal Dialysis Complication
• Renal Insufficiency

Intervention

Other:
• 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

Locations

Country	Name	City	State
Thailand	Chaiyaphum Hospital	Chaiyaphum
Thailand	Khon Kaen Hospital	Khon Kaen
Thailand	Srinagarind Hospital	Khon Kaen

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinic contacts	Communication by phone or messaging app between peritoneal dialysis patients or surrogate regarding clinical concern about symptoms or hydration metrics	through study completion, average 1 year
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	through study completion, average 1 year
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	through study completion, average 1 year
Secondary	Technique failure	Inability to continue peritoneal dialysis for any reason requiring a change to hemodialysis	through study completion, average 1 year
Secondary	Mortality	Death	through study completion, average 1 year