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

NCT04797195 | Completed Results

• 2 other identifiers: 2018A0131451R21TW010963-01A1
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 3

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.

Conditions

Kidney Failure, Chronic; Peritoneal Dialysis Complication

Keywords

mobile health; peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Complication of Over Hydration Requiring Hospitalization

  through study completion, average 1 year

• Technique Failure

  through study completion, average 1 year

• Mortality

  through study completion, average 1 year

Other Outcomes (1)

• Clinic Contacts

  through study completion, average 1 year

Study Arms (2)

CKD-PD app user group

EXPERIMENTAL

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

Other: CKD-PD app with home monitoring equipment

Usual care group

NO INTERVENTION

Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method

Interventions

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

CKD-PD app user group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Khon Kaen University: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (3)

Chaiyaphum Hospital

Chaiyaphum, Thailand

Location

Khon Kaen Hospital

Khon Kaen, 40000, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• Anutrakulchai S, Tatiyanupanwong S, Kananuraks S, Lukkanalikitkul E, Kongpetch S, Chotmongkol W, Morley MG, Thinkhamrop W, Thinkhamrop B, Kleebchaiyaphum C, Khianchanach K, Chunghom T, Morley KE. Effect of the Chronic Kidney Disease-Peritoneal Dialysis (CKD-PD) App on Improvement of Overhydration Treatment in Patients on Peritoneal Dialysis: Randomized Controlled Trial. J Med Internet Res. 2025 May 21;27:e70641. doi: 10.2196/70641.

  PMID: 40397925 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Katharine Morley, MD
• Organization: Massachusetts General Hospital Center for Global Health

kemorley@mgh.harvard.edu

617-726-2000

Study Officials

• Katharine E Morley, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Sirirat Anutrakulchai, MD PhD

  Srinagarind Hospital, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician, Department of Medicine, PI

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 15, 2021
• Study Start: December 13, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: February 11, 2025
• Results First Posted: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (3)