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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21TW010963-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Khon Kaen University | OTHER |
| Fogarty International Center of the National Institute of Health | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, average 1 year |
| Technique Failure |
| Measure | Description | Time Frame |
|---|---|---|
| Clinic Contacts | Communication by phone or messaging app between peritoneal dialysis patients or surrogate regarding clinical concern about symptoms or hydration metrics | through study completion, average 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katharine E Morley, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Sirirat Anutrakulchai, MD PhD | Srinagarind Hospital, Khon Kaen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaiyaphum Hospital | Chaiyaphum | Thailand | ||||
| Khon Kaen Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40397925 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | clinical interventions | through study completion, average 1 year |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Technique failure | Renal and urinary disorders | Non-systematic Assessment | Unable to continue on peritoneal dialysis due to complications such as catheter malfunction, recurrent peritonitis, inadequate dialysis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katharine Morley, MD | Massachusetts General Hospital Center for Global Health | 617-726-2000 | kemorley@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 2, 2021 | Feb 8, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Inability to continue peritoneal dialysis for any reason requiring a change to hemodialysis |
| through study completion, average 1 year |
| Mortality | Deaths occuring during study period for any cause | through study completion, average 1 year |
| Khon Kaen |
| 40000 |
| Thailand |
| Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| Withdrawal by Subject |
|
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hospital | Count of Participants | Participants |
|
Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method |
|
|
| Secondary | 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 | Posted | Number | events | through study completion, average 1 year |
|
|
|
| Secondary | Technique Failure | Inability to continue peritoneal dialysis for any reason requiring a change to hemodialysis | Posted | Count of Participants | Participants | through study completion, average 1 year |
|
|
|
| Secondary | Mortality | Deaths occuring during study period for any cause | Posted | Count of Participants | Participants | through study completion, average 1 year |
|
|
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| Other Pre-specified | Clinic Contacts | Communication by phone or messaging app between peritoneal dialysis patients or surrogate regarding clinical concern about symptoms or hydration metrics | Posted | Number | events | through study completion, average 1 year |
|
|
|
| 8 |
| 103 |
| 54 |
| 103 |
| 0 |
| 103 |
| EG001 | 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 | 15 | 105 | 75 | 105 | 0 | 105 |
|
| Hospitalizations | General disorders | Non-systematic Assessment | All cause hospitalizations |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |