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

July 8, 2021 updated by: Na Jiang, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of PD choice
Time Frame: up to 90 days
up to 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The aPD utilization rate
Time Frame: up to 180 days
up to 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Wei Fang, MD, Renji hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • self-care PD ability

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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