Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT04797195
Status:
COMPLETED
Last Update Posted:
2025-02-11
First Post:
2021-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Care for Peritoneal Dialysis Patients With the CKD-PD App
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kemorley@mgh.harvard.edu', 'phone': '617-726-2000', 'title': 'Katharine Morley, MD', 'organization': 'Massachusetts General Hospital Center for Global Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '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', 'description': 'Adverse events were considered to be deaths, technique failure (change from peritoneal dialysis to another form of renal replacement therapy), and all cause hospitalizations.\n\nPatients undergoing peritoneal dialysis have frequent occurrences of death, technique failure and hospitalizations at baseline', 'eventGroups': [{'id': 'EG000', 'title': 'CKD-PD App User Group', '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\n\nCKD-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', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'deathsNumAffected': 8, 'seriousNumAffected': 54}, {'id': 'EG001', 'title': 'Usual Care Group', 'description': 'Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 0, 'seriousNumAtRisk': 105, 'deathsNumAffected': 15, 'seriousNumAffected': 75}], 'seriousEvents': [{'term': 'Technique failure', 'notes': 'Unable to continue on peritoneal dialysis due to complications such as catheter malfunction, recurrent peritonitis, inadequate dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'notes': 'All cause hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Interventions for Over Hydration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CKD-PD App User Group', '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\n\nCKD-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'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method'}], 'classes': [{'categories': [{'measurements': [{'value': '473', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, average 1 year', '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', 'unitOfMeasure': 'clinical interventions', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complication of Over Hydration Requiring Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CKD-PD App User Group', '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\n\nCKD-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'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, average 1 year', 'description': 'Clinical event due to over hydration requiring hospitalization. Includes volume overload, infections, peritonitis, major adverse cardiac event, severe hypertension or stroke', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Technique Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CKD-PD App User Group', '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\n\nCKD-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'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, average 1 year', 'description': 'Inability to continue peritoneal dialysis for any reason requiring a change to hemodialysis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CKD-PD App User Group', '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\n\nCKD-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'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, average 1 year', 'description': 'Deaths occuring during study period for any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinic Contacts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CKD-PD App User Group', '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\n\nCKD-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'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method'}], 'classes': [{'categories': [{'measurements': [{'value': '473', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, average 1 year', 'description': 'Communication by phone or messaging app between peritoneal dialysis patients or surrogate regarding clinical concern about symptoms or hydration metrics', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CKD-PD App User Group', '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\n\nCKD-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'}, {'id': 'FG001', 'title': 'Usual Care Group', 'description': 'Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Change from PD', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CKD-PD App User Group', '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\n\nCKD-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'}, {'id': 'BG001', 'title': 'Usual Care Group', 'description': 'Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'spread': '15.5', 'groupId': 'BG000'}, {'value': '54.8', 'spread': '14.8', 'groupId': 'BG001'}, {'value': '54.3', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Thailand', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hospital', 'classes': [{'categories': [{'title': 'Srinagarind', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Khon Kaen', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Chaiyaphum', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-02', 'size': 379990, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-02-08T10:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-08', 'studyFirstSubmitDate': '2021-03-11', 'resultsFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-08', 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinic Contacts', 'timeFrame': 'through study completion, average 1 year', 'description': 'Communication by phone or messaging app between peritoneal dialysis patients or surrogate regarding clinical concern about symptoms or hydration metrics'}], 'primaryOutcomes': [{'measure': 'Clinical Interventions for Over Hydration', 'timeFrame': 'through study completion, average 1 year', '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'}], 'secondaryOutcomes': [{'measure': 'Complication of Over Hydration Requiring Hospitalization', 'timeFrame': 'through study completion, average 1 year', 'description': 'Clinical event due to over hydration requiring hospitalization. Includes volume overload, infections, peritonitis, major adverse cardiac event, severe hypertension or stroke'}, {'measure': 'Technique Failure', 'timeFrame': 'through study completion, average 1 year', 'description': 'Inability to continue peritoneal dialysis for any reason requiring a change to hemodialysis'}, {'measure': 'Mortality', 'timeFrame': 'through study completion, average 1 year', 'description': 'Deaths occuring during study period for any cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mobile health', 'peritoneal dialysis'], 'conditions': ['Kidney Failure, Chronic', 'Peritoneal Dialysis Complication']}, 'referencesModule': {'references': [{'pmid': '40397925', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic kidney disease from any cause on home based peritoneal dialysis\n* age greater than 18 years\n* access to a smart phone capable of running the CKD-PD app\n\nExclusion Criteria:\n\n* vulnerable populations including children, prisoners, pregnant women, individuals with cognitive impairment, refugees\n* unwillingness to sign consent or participate in the study'}, 'identificationModule': {'nctId': 'NCT04797195', 'briefTitle': 'Improving Care for Peritoneal Dialysis Patients With the CKD-PD App', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Improving Care for Peritoneal Dialysis Patients With the CKD-PD App', 'orgStudyIdInfo': {'id': '2018A013145'}, 'secondaryIdInfos': [{'id': '1R21TW010963-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21TW010963-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CKD-PD app user group', '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', 'interventionNames': ['Other: CKD-PD app with home monitoring equipment']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care group', 'description': 'Patients on peritoneal dialysis using handwritten notebook to record record blood pressure, body weight, and dialysis fluid removed; measurements obtained through usual method'}], 'interventions': [{'name': 'CKD-PD app with home monitoring equipment', 'type': 'OTHER', 'description': 'use home monitoring equipment to measure blood pressure, body weight, and dialysate fluid volume and record in CKD-PD app', 'armGroupLabels': ['CKD-PD app user group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chaiyaphum', 'country': 'Thailand', 'facility': 'Chaiyaphum Hospital', 'geoPoint': {'lat': 15.81047, 'lon': 102.02881}}, {'zip': '40000', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Khon Kaen Hospital', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Srinagarind Hospital', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Katharine E Morley, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Sirirat Anutrakulchai, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Srinagarind Hospital, Khon Kaen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Khon Kaen University', 'class': 'OTHER'}, {'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Physician, Department of Medicine, PI', 'investigatorFullName': 'Katharine E. Morley', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}