Kidney Failure, Chronic, Peritoneal Dialysis Complication
Conditions
Keywords
mobile health, peritoneal dialysis
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.
Interventions
use home monitoring equipment to measure blood pressure, body weight, and dialysate fluid volume and record in CKD-PD app
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Interventions for Over Hydration | 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
| Measure | Time frame | Description |
|---|---|---|
| Complication of Over Hydration Requiring Hospitalization | 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 |
| Technique Failure | through study completion, average 1 year | Inability to continue peritoneal dialysis for any reason requiring a change to hemodialysis |
| Mortality | through study completion, average 1 year | Deaths occuring during study period for any cause |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinic Contacts | 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 |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 103 |
| 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 | 105 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Change from PD | 15 | 15 |
| Overall Study | Death | 8 | 15 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | CKD-PD App User Group | Usual Care Group | Total |
|---|---|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 15.5 | 54.8 years STANDARD_DEVIATION 14.8 | 54.3 years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants | 105 Participants | 208 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hospital Chaiyaphum | 48 Participants | 48 Participants | 96 Participants |
| Hospital Khon Kaen | 35 Participants | 37 Participants | 72 Participants |
| Hospital Srinagarind | 20 Participants | 20 Participants | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 103 Participants | 105 Participants | 208 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Thailand | 103 participants | 105 participants | 208 participants |
| Sex: Female, Male Female | 63 Participants | 54 Participants | 117 Participants |
| Sex: Female, Male Male | 40 Participants | 51 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 103 | 15 / 105 |
| other Total, other adverse events | 0 / 103 | 0 / 105 |
| serious Total, serious adverse events | 54 / 103 | 75 / 105 |
Outcome results
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
Time frame: through study completion, average 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CKD-PD App User Group | Clinical Interventions for Over Hydration | 473 clinical interventions |
| Usual Care Group | Clinical Interventions for Over Hydration | 164 clinical interventions |
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
Time frame: through study completion, average 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CKD-PD App User Group | Complication of Over Hydration Requiring Hospitalization | 67 events |
| Usual Care Group | Complication of Over Hydration Requiring Hospitalization | 113 events |
Mortality
Deaths occuring during study period for any cause
Time frame: through study completion, average 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CKD-PD App User Group | Mortality | 8 Participants |
| Usual Care Group | Mortality | 15 Participants |
Technique Failure
Inability to continue peritoneal dialysis for any reason requiring a change to hemodialysis
Time frame: through study completion, average 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CKD-PD App User Group | Technique Failure | 14 Participants |
| Usual Care Group | Technique Failure | 15 Participants |
Clinic Contacts
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CKD-PD App User Group | Clinic Contacts | 473 events |
| Usual Care Group | Clinic Contacts | 164 events |