Improving Care for Peritoneal Dialysis Patients With the CKD-PD App
Primary Purpose
Kidney Failure, Chronic, Peritoneal Dialysis Complication
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
CKD-PD app with home monitoring equipment
Sponsored by
About this trial
This is an interventional supportive care trial for Kidney Failure, Chronic focused on measuring mobile health, peritoneal dialysis
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
Sites / Locations
- Chaiyaphum Hospital
- Khon Kaen Hospital
- Srinagarind Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CKD-PD app user group
Usual care group
Arm Description
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
Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Technique failure
Inability to continue peritoneal dialysis for any reason requiring a change to hemodialysis
Mortality
Death
Full Information
NCT ID
NCT04797195
First Posted
March 11, 2021
Last Updated
May 2, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Khon Kaen University
1. Study Identification
Unique Protocol Identification Number
NCT04797195
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Peritoneal Dialysis Complication
Keywords
mobile health, peritoneal dialysis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CKD-PD app user group
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method
Intervention Type
Other
Intervention Name(s)
CKD-PD app with home monitoring equipment
Intervention Description
use home monitoring equipment to measure blood pressure, body weight, and dialysate fluid volume and record in CKD-PD app
Primary Outcome Measure Information:
Title
Clinical interventions for over hydration
Description
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
Time Frame
through study completion, average 1 year
Secondary Outcome Measure Information:
Title
Complication of over hydration requiring hospitalization
Description
Clinical event due to over hydration requiring hospitalization. Includes volume overload, infections, peritonitis, major adverse cardiac event, severe hypertension or stroke
Time Frame
through study completion, average 1 year
Title
Technique failure
Description
Inability to continue peritoneal dialysis for any reason requiring a change to hemodialysis
Time Frame
through study completion, average 1 year
Title
Mortality
Description
Death
Time Frame
through study completion, average 1 year
Other Pre-specified Outcome Measures:
Title
Clinic contacts
Description
Communication by phone or messaging app between peritoneal dialysis patients or surrogate regarding clinical concern about symptoms or hydration metrics
Time Frame
through study completion, average 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharine E Morley, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sirirat Anutrakulchai, MD PhD
Organizational Affiliation
Srinagarind Hospital, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaiyaphum Hospital
City
Chaiyaphum
Country
Thailand
Facility Name
Khon Kaen Hospital
City
Khon Kaen
ZIP/Postal Code
40000
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Care for Peritoneal Dialysis Patients With the CKD-PD App
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