A Mobile Application Based Dietary Self Management Intervention in Chinese Chronic Kidney Disease Patients

NCT ID: NCT04940819

Last Updated: 2021-06-28

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

9863 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2023-06-30

Brief Summary

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This is a multi-center randomized controlled study. This study aims to investigate the acceptability and efficacy of a newly developed mobile application in the dietary management of chronic kidney disease (CKD) patients.

Detailed Description

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The prevalence of CKD has reached 10.8% in China. Increasing in prevalence of other non-communicable disease such as hypertension, diabetes and obesity is contributing to this rise in CKD and end-stage renal disease prevalence. Diet is a strong modifiable factor in these diseases. Dietary control is also an integral part in CKD disease self management. However, the complexity in the dietary management of CKD makes it hard for patients to adequately self manage. With the development of smart phone, many mobile applications have been developed to suit the need of patients with chronic diseases. But there has been a scarce of randomized trial to support the feasibility, acceptability and efficacy of these mobile applications.

Our study aims to employ a newly developed dietary logging and monitoring application in the primary care setting of CKD patients to test its acceptability and efficacy in disease control.

The application is developed by a multidisciplinary team in a tertiary care center. The main features include searching and logging foods, receiving realtime feedback on key nutrient intake levels and facilitating patient-care giving communication.

We plan to enroll 14 tertiary hospitals and 42 secondary hospitals in 7 geographical regions in China aiming to reach participants in resource poor areas. Participants will be randomized with 1 to 1 ratio to either receiving mobile application dietary intervention or usual dietary consultation. The planned intervention period is 3 months. We will monitor biochemical parameters relating to dietary control and evaluate patient-centered outcomes concerning CKD self management and control.

Conditions

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Chronic Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mobile Application Intervention

Participants in this arm will receive mobile application dietary intervention as well as usual CKD dietary care.

Group Type EXPERIMENTAL

Mobile Application for Dietary Management

Intervention Type BEHAVIORAL

A mobile application developed by a multi-disciplinary team will be used in the dietary management of CKD patients. The application is patient orientated. It has 4 core features including food searching, dietary logging, personalized key nutrient intake feedback and patient-caregiver interaction.

Care as Usual

Participants in this arm will receive usual CKD dietary care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile Application for Dietary Management

A mobile application developed by a multi-disciplinary team will be used in the dietary management of CKD patients. The application is patient orientated. It has 4 core features including food searching, dietary logging, personalized key nutrient intake feedback and patient-caregiver interaction.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with CKD for more than 3 months
* Objective measures of kidney disease (fulfill one of the following): 1) eGFR≤60ml/min/1.73m\^2; 2) Proteinuria (Protein + on dipstick or 24 hour urine protein\>0.3g or albumin-to-creatinine ratio (ACR) \>30mg/mmol or protein-to-creatinine ratio (PCR) \>50mg/mmol); 3) Imaging proven kidney disease (Atrophy, stone formation, cystic kidney disease, or other structural abnormality)
* Having access to a mobile phone and is capable of using the dietary intervention application

Exclusion Criteria

* Can not provide history of kidney disease or can not provide laboratory result for the past 3 month
* Can not use a mobile phone or deemed unfit to participate by their treating nephrologist
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Limeng Chen

Director, Department of Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Limeng Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Xixi Zheng, MD

Role: CONTACT

+8613521145030

Peng Xia, MD

Role: CONTACT

+8613811684903

Facility Contacts

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Xixi Zheng, MD

Role: primary

+8613521145030

Peng Xia, MD

Role: backup

+8613811684903

References

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Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6.

Reference Type BACKGROUND
PMID: 22386035 (View on PubMed)

Stevenson JK, Campbell ZC, Webster AC, Chow CK, Tong A, Craig JC, Campbell KL, Lee VW. eHealth interventions for people with chronic kidney disease. Cochrane Database Syst Rev. 2019 Aug 6;8(8):CD012379. doi: 10.1002/14651858.CD012379.pub2.

Reference Type BACKGROUND
PMID: 31425608 (View on PubMed)

Lim JH, Lim CK, Ibrahim I, Syahrul J, Mohamed Zabil MH, Zakaria NF, Daud ZAM. Limitations of Existing Dialysis Diet Apps in Promoting User Engagement and Patient Self-Management: Quantitative Content Analysis Study. JMIR Mhealth Uhealth. 2020 Jun 1;8(6):e13808. doi: 10.2196/13808.

Reference Type BACKGROUND
PMID: 32478665 (View on PubMed)

Other Identifiers

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CRISS-Diet

Identifier Type: -

Identifier Source: org_study_id

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