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

NCT ID: NCT04967547

Last Updated: 2021-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease (CKD) Stage 5

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Self-care PD ability assessment form

Intervention Type OTHER

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

Education

Intervention Type OTHER

Education on renal replacement therapy and dialysis

Control group

education on renal replacement therapy and dialysis

Group Type ACTIVE_COMPARATOR

Education

Intervention Type OTHER

Education on renal replacement therapy and dialysis

Interventions

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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

Intervention Type OTHER

Education

Education on renal replacement therapy and dialysis

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Na Jiang

Department of Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Fang, MD

Role: STUDY_DIRECTOR

RenJi Hospital

Locations

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Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Na Jiang, MD

Role: CONTACT

+86-21-53882014

Other Identifiers

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self-care PD ability

Identifier Type: -

Identifier Source: org_study_id

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