Back to resultsEffect of Pre-emptive Assessment of Self-care Peritoneal Dialysis (PD) Ability on PD Choice in Patients With Stage 5 Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease (CKD) Stage 5
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Self-care PD ability assessment form
Education
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Disease (CKD) Stage 5
Eligibility Criteria
Inclusion Criteria:
- Age >=18 years old;
- Need dialysis within 6 months;
- Informed consent.
Exclusion Criteria:
- Absolute PD contraindications;
- Need urgent dialysis;
- RTX as initial renal replacement therapy.
Sites / Locations
- Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
be evaluated by using the self-care PD feasibility assessment in addition to education on renal replacement therapy and dialysis
education on renal replacement therapy and dialysis
Outcomes
Primary Outcome Measures
The rate of PD choice
Secondary Outcome Measures
The aPD utilization rate
Full Information
NCT ID
NCT04967547
First Posted
July 8, 2021
Last Updated
July 8, 2021
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04967547
Brief Title
Effect of Pre-emptive Assessment of Self-care Peritoneal Dialysis (PD) Ability on PD Choice in Patients With Stage 5 Chronic Kidney Disease
Official Title
Effect of Pre-emptive Assessment of Self-care Peritoneal Dialysis (PD) Ability on PD Choice in Patients With Stage 5 Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Peritoneal dialysis is an effective renal replacement therapy with higher quality of life and lower treatment cost than hemodialysis.However, the application rate of peritoneal dialysis is much lower than that of hemodialysis. One of the reasons is that patients need to complete fluid changing operation independently, which is especially challenging for elderly and frail patients. Assisted peritoneal dialysis can help patients with independent dialysis disorders to complete dialysis. Currently, there is a lack of standard tools to assess patients' ability to conduct independent dialysis and to determine whether assisted dialysis is needed. Moreover, routine assessment is arranged after the training of dialysis operation, which leads to some patients giving up the procedure at an early stage, resulting in a low selection rate of the procedure.The purpose of this study was to investigate the effect of using a standard scale to evaluate the ability to perform abdominal dialysis in patients with stage 5 chronic kidney disease (CKD) before deciding on dialysis modality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease (CKD) Stage 5
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
be evaluated by using the self-care PD feasibility assessment in addition to education on renal replacement therapy and dialysis
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
education on renal replacement therapy and dialysis
Intervention Type
Other
Intervention Name(s)
Self-care PD ability assessment form
Intervention Description
Subjects will be evaluated using the self-care PD feasibility assessment tool within 7 days after randomization. The evaluation results will be provided to the patient on the same day
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Education on renal replacement therapy and dialysis
Primary Outcome Measure Information:
Title
The rate of PD choice
Time Frame
up to 90 days
Secondary Outcome Measure Information:
Title
The aPD utilization rate
Time Frame
up to 180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >=18 years old;
Need dialysis within 6 months;
Informed consent.
Exclusion Criteria:
Absolute PD contraindications;
Need urgent dialysis;
RTX as initial renal replacement therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Na Jiang, MD
Phone
+86-21-53882014
Email
Jiangjiang198311@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Fang, MD
Organizational Affiliation
RenJi Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Pre-emptive Assessment of Self-care Peritoneal Dialysis (PD) Ability on PD Choice in Patients With Stage 5 Chronic Kidney Disease
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