Effect of Pre-emptive Assessment of Self-care Peritoneal Dialysis (PD) Ability on PD Choice in Patients With Stage 5 Chronic Kidney Disease

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04967547
Collaborator
(none)
232
1
2
36
6.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Self-care PD ability assessment form
  • Other: Education
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
232 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

be evaluated by using the self-care PD feasibility assessment in addition to education on renal replacement therapy and dialysis

Other: Self-care PD ability assessment form
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

Other: Education
Education on renal replacement therapy and dialysis

Active Comparator: Control group

education on renal replacement therapy and dialysis

Other: Education
Education on renal replacement therapy and dialysis

Outcome Measures

Primary Outcome Measures

  1. The rate of PD choice [up to 90 days]

Secondary Outcome Measures

  1. The aPD utilization rate [up to 180 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age >=18 years old;

  2. Need dialysis within 6 months;

  3. Informed consent.

Exclusion Criteria:
  1. Absolute PD contraindications;

  2. Need urgent dialysis;

  3. RTX as initial renal replacement therapy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai China 200001

Sponsors and Collaborators

  • Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Wei Fang, MD, RenJi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Na Jiang, Department of Nephrology, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT04967547
Other Study ID Numbers:
  • self-care PD ability
First Posted:
Jul 19, 2021
Last Update Posted:
Jul 19, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2021