Trial Outcomes & Findings for Improving Care for Peritoneal Dialysis Patients With the CKD-PD App (NCT NCT04797195)

NCT ID: NCT04797195

Last Updated: 2025-02-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 208 participants
• Primary outcome timeframe: through study completion, average 1 year
• Results posted on: 2025-02-11

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	103	105
Overall Study COMPLETED	77	73
Overall Study NOT COMPLETED	26	32

Reasons for withdrawal

Measure	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	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
Overall Study Death	8	15
Overall Study Change from PD	15	15
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	CKD-PD App User Group n=103 Participants 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	Usual Care Group n=105 Participants Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method	Total n=208 Participants Total of all reporting groups
Age, Continuous	53.9 years STANDARD_DEVIATION 15.5 • n=5 Participants	54.8 years STANDARD_DEVIATION 14.8 • n=7 Participants	54.3 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	54 Participants n=7 Participants	117 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	51 Participants n=7 Participants	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	103 Participants n=5 Participants	105 Participants n=7 Participants	208 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	103 Participants n=5 Participants	105 Participants n=7 Participants	208 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Thailand	103 participants n=5 Participants	105 participants n=7 Participants	208 participants n=5 Participants
Hospital Srinagarind	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Hospital Khon Kaen	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Hospital Chaiyaphum	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	CKD-PD App User Group n=103 Participants 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	Usual Care Group n=105 Participants Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method
Clinical Interventions for Over Hydration	473 clinical interventions	164 clinical interventions

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	CKD-PD App User Group n=103 Participants 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	Usual Care Group n=105 Participants Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method
Complication of Over Hydration Requiring Hospitalization	67 events	113 events

SECONDARY outcome

Timeframe: through study completion, average 1 year

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

Outcome measures

Measure	CKD-PD App User Group n=103 Participants 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	Usual Care Group n=105 Participants Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method
Technique Failure	14 Participants	15 Participants

SECONDARY outcome

Timeframe: through study completion, average 1 year

Deaths occuring during study period for any cause

Outcome measures

Measure	CKD-PD App User Group n=103 Participants 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	Usual Care Group n=105 Participants Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method
Mortality	8 Participants	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	CKD-PD App User Group n=103 Participants 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	Usual Care Group n=105 Participants Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method
Clinic Contacts	473 events	164 events

Adverse Events

CKD-PD App User Group

Serious events: 54 serious events

Other events: 0 other events

Deaths: 8 deaths

Usual Care Group

Serious events: 75 serious events

Other events: 0 other events

Deaths: 15 deaths

Serious adverse events

Measure	CKD-PD App User Group n=103 participants at risk 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	Usual Care Group n=105 participants at risk Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method
Renal and urinary disorders Technique failure	13.6% 14/103 • Number of events 14 • Adverse events were collected during the study period for each individual, with a median follow up time in the app group of 11.2 months and non-app group of 11 months Adverse events were considered to be deaths, technique failure (change from peritoneal dialysis to another form of renal replacement therapy), and all cause hospitalizations. Patients undergoing peritoneal dialysis have frequent occurrences of death, technique failure and hospitalizations at baseline	14.3% 15/105 • Number of events 15 • Adverse events were collected during the study period for each individual, with a median follow up time in the app group of 11.2 months and non-app group of 11 months Adverse events were considered to be deaths, technique failure (change from peritoneal dialysis to another form of renal replacement therapy), and all cause hospitalizations. Patients undergoing peritoneal dialysis have frequent occurrences of death, technique failure and hospitalizations at baseline
General disorders Hospitalizations	38.8% 40/103 • Adverse events were collected during the study period for each individual, with a median follow up time in the app group of 11.2 months and non-app group of 11 months Adverse events were considered to be deaths, technique failure (change from peritoneal dialysis to another form of renal replacement therapy), and all cause hospitalizations. Patients undergoing peritoneal dialysis have frequent occurrences of death, technique failure and hospitalizations at baseline	57.1% 60/105 • Adverse events were collected during the study period for each individual, with a median follow up time in the app group of 11.2 months and non-app group of 11 months Adverse events were considered to be deaths, technique failure (change from peritoneal dialysis to another form of renal replacement therapy), and all cause hospitalizations. Patients undergoing peritoneal dialysis have frequent occurrences of death, technique failure and hospitalizations at baseline

Other adverse events

Adverse event data not reported

Additional Information

Katharine Morley, MD

Massachusetts General Hospital Center for Global Health

Phone: 617-726-2000

Email: kemorley@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place