Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT02782234
Status:
UNKNOWN
Last Update Posted:
2016-05-25
First Post:
2016-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application Contract Management Mode in Maintaining PD Fluid Balance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-24', 'studyFirstSubmitDate': '2016-04-08', 'studyFirstSubmitQcDate': '2016-05-24', 'lastUpdatePostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of fluid intake and output keep in balance measured in ml.', 'timeFrame': '24 hours', 'description': 'as the physiological parameter for this Outcome. Volume measurement unit should be used in pd subjects, the unit ml.'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'two times a day, through study completion, an average of 6 months. changed from baseline', 'description': 'two times a day, blood pressure measure at a.m.6∶0 0～ 8∶0 0 ,p.m.15∶0 0～ 18∶0 0. The subjects for the first time measuring blood pressure for the baseline.'}, {'measure': 'Change in weight', 'timeFrame': 'once a day, through study completion, an average of 6 months. changed from baseline', 'description': 'The subjects for the first time measuring weight for the baseline measured in kg.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contract Management PD']}, 'descriptionModule': {'briefSummary': 'Contract management is a new management mode.\n\nTo help patients achieve fluid balance through contract management, that is:\n\n1. edema, congestive heart failure and other similar symptoms begin to reduce to disappear;\n2. Blood pressure control in normal range, that is 90-140/60-90mmHg, or the target value prescribed by the doctors；\n3. Fluid intake and output keep in balance;\n4. No imbalance symptoms turn out, such as edema, congestive heart failure, etc.', 'detailedDescription': "Contract management is a new management mode, it stipulate and constraint various relationship by various duties, institutions and regulations.\n\nTo help patients achieve fluid balance through contract management, that is:\n\n1. edema, congestive heart failure and other similar symptoms begin to reduce to disappear;\n2. Blood pressure control in normal range, that is 90-140/60-90mmHg, or the target value prescribed by the doctors；\n3. Fluid intake and output keep in balance;\n4. No imbalance symptoms turn out, such as edema, congestive heart failure, etc.\n\nIn addition to help keeping the fluid balance through contract balance, but also:\n\n1. Improve compliance;\n2. Improve the patients' cognition of fluid balance;\n3. Improve the ability of self-management of fluid balance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Older or equal to 18 years, younger or equal to 65 years, CAPD duration over 6 months\n2. Edema or congestive heart failure happen\n3. Patients with poor control of blood pressure, that is less than 90/60mmHg,or over 140/90mmHg, or the Bp does not meet the value given by doctors\n4. Patients with fluid imbalance of intake and output.\n\nExclusion Criteria:\n\n1. Younger than 18, or older than 65, or CAPD period less than 6 months\n2. The primary disease is high blood pressure, or edema due to low protein\n3. Patients that lost control of daily life\n4. Malignant tumor or pregnancy\n5. Falling in Chronic infection or severe complication within 1 month, such as hepatic disease, hemorrhage of digestive tract, etc.\n6. Patients with cognition impairment, conscious disorder, or mental disease.'}, 'identificationModule': {'nctId': 'NCT02782234', 'acronym': 'ACMMPDFB', 'briefTitle': 'Application Contract Management Mode in Maintaining PD Fluid Balance', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'Application of Contract Management Mode in Maintaining Body Fluid Balance of Peritoneal Dialysis Patients', 'orgStudyIdInfo': {'id': '2 ndharbinmu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'not contract management', 'description': 'monthly follow-up phone or family visit completed as regulation, and instruct them proper healthy training.'}, {'type': 'EXPERIMENTAL', 'label': 'Contract management', 'description': 'In accordance with the contract content, researchers and participants should manage and maintain the liquid balance of the participants. Signed doctors and nurses should undergo the follow-up phone or family visit on time, instruct them proper healthy training, and provided necessary information data. By telephone, SMS, wechat, remind and urge the participants to take the lifestyle and behavior regulate in the contract. Participants should supervise and manage the fluid unbalance (Edema, hypertension, heart failure, and fluid imbalance of intake and output etc.), and feedback the Management and supervision to researchers according to contract.', 'interventionNames': ['Behavioral: Contract management']}], 'interventions': [{'name': 'Contract management', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Contract management']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Supervisor nurse', 'investigatorFullName': 'Li Liu', 'investigatorAffiliation': 'The Second Affiliated Hospital of Harbin Medical University'}}}}