Clinical trial NCT04797195: Improving Care for Peritoneal Dialysis Patients With the CKD-PD App
Official title: Improving Care for Peritoneal Dialysis Patients With the CKD-PD App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Peritoneal Dialysis Complication
Keywords: mobile health
peritoneal dialysis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Khon Kaen University
name: Fogarty International Center of the National Institute of Health
First posted: 2021-03-15
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Interventions for Over Hydration
timeFrame: through study completion, average 1 year
Secondary outcomes:
measure: Complication of Over Hydration Requiring Hospitalization
timeFrame: through study completion, average 1 year
measure: Technique Failure
timeFrame: through study completion, average 1 year
measure: Mortality
timeFrame: through study completion, average 1 year
Other outcomes:
measure: Clinic Contacts
timeFrame: through study completion, average 1 year
Locations:
city: Chaiyaphum
country: Thailand
facility: Chaiyaphum Hospital
city: Khon Kaen
country: Thailand
facility: Khon Kaen Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
Study officials:
affiliation: Massachusetts General Hospital
name: Katharine E Morley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Srinagarind Hospital, Khon Kaen University
name: Sirirat Anutrakulchai, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: