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Completed

NCT Number: NCT04797195

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

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.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Dialysis Complication Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chaiyaphum Hospital, Chaiyaphum, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKD-PD app with home monitoring equipment

Other

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

Primary outcomes

  1. Clinical Interventions for Over Hydration

    Time frame: through study completion, average 1 year

    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

Secondary outcomes

  1. Complication of Over Hydration Requiring Hospitalization

    Time frame: through study completion, average 1 year

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

  2. Technique Failure

    Time frame: through study completion, average 1 year

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

  3. Mortality

    Time frame: through study completion, average 1 year

    Deaths occuring during study period for any cause

Other outcomes

  1. Clinic Contacts

    Time frame: through study completion, average 1 year

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • Khon Kaen University

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2021
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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