Dietary Education Intervention Impact on Dietary Protein Intake in PD

NCT02426580 | Completed Results DMC

• 1 other identifier: Chengdu 3rd Hospital
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a prospective randomized controlled pilot trial/(a combined prospective and retrospective study). The investigators will use wechat intervening dietary protein intake in patients treated with peritoneal dialysis.

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (1)

• Normalized Protein Catabolic Rate (nPCR)

  We use software (PD ADEQUEST 2.0) to conduct the Peritoneal Equilibration Test (PET) test. The result of PET test can offered the value of nPCR. nPCR can estimate daily protein intake of patients. Its units is g/(kg\*d).

  12 months

Study Arms (2)

Intervention with wechat group

EXPERIMENTAL

The wechat model will provide information of protein, calcium, phosphorus and sodium intake, which were suggested by the current KDIGO/ KDOQI guideline.

Behavioral: wechat

Controlled group

NO INTERVENTION

Only conventional education every 3 months during routing clinical visit

Interventions

wechat BEHAVIORAL

The wechat model of dietary education every 1 month by cellphone

Also known as: wechat model

Intervention with wechat group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All patients followed at the PD center who successful completed training and have received treatment for at least 1 month.
• \. The life expectancy will be more than one year.
• \. All patients will provide written informed consent.

You may not qualify if:

• the patients will be severe ill status and unlikely to survive for 12 months.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead
• Baxter Healthcare Corporation: collaborator

Limitations and Caveats

It is not a randomized controlled study. The patients assigned to both groups according to their willing. Most enrolled to intervention group. To improve the amount of control group, we retrospectively recruited 35 patients from recent 1 year.

Results Point of Contact

• Title: Dr. Gong Rong, Dr. Han Tianzhao, Dr. Leonard Stern
• Organization: The Nephrology Department, the Chengdu Second Affiliated Hospital of Chongqing Medical University, the Third Peoples's Hospital of Chengdu

gongr2006@sina.com

+86 028-61318708

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, chief physician

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 27, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2018
• Last Updated: July 10, 2019
• Results First Posted: June 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will become available at May 2019 and for 2 years
• Access Criteria: No criteria.