A Mobile Application Based Dietary Self Management Intervention in Chinese Chronic Kidney Disease Patients (CRISS-MADE)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Unknown

Conditions

Chronic Renal Disease

Treatments

Behavioral: Mobile Application for Dietary Management

Study type

Interventional

Funder types

Other

Identifiers

NCT04940819

CRISS-Diet

Details and patient eligibility

About

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.

Full description

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.

Enrollment

9,863 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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