Clinical trial NCT04940819: A Mobile Application Based Dietary Self Management Intervention in Chinese Chronic Kidney Disease Patients
Official title: A Mobile Application Based Dietary Self Management Intervention in Chinese Chronic Kidney Disease Patients: a Multi-Center Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Renal Disease
Keywords: Chronic Renal Disease
Dietary Management
Mobile Application
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 9863
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dietary Intake
timeFrame: 3 months
measure: Diet Quality
timeFrame: 3 months
measure: Blood Pressure
timeFrame: 3 months
measure: change in estimated Glomerular Filtration Rate (eGFR)
timeFrame: 3 months
measure: Change in Proteinuria
timeFrame: 3 months
measure: Change in Disease Related Quality of life
timeFrame: 3 months
measure: Change in Self-Efficacy for Managing Chronic Disease Scale
timeFrame: 3 months
measure: Change in Perceived Medical Condition Self-Management Scale (PMCSMS）
timeFrame: 3 months
Secondary outcomes:
measure: Blood Chemistry (Potassium, Bicarbonate, Phosphate)
timeFrame: 3 months
measure: Urine Sodium/potassium Ratio
timeFrame: 3 months
measure: Salt Taste Threshold
timeFrame: 3 months
measure: Kidney Nutrition Knowledge, Attitude and Practice
timeFrame: 3 months
measure: Acceptability of the Application
timeFrame: 3 months
measure: Adherence
timeFrame: 3 months
measure: Adoption
timeFrame: 3 months
measure: Change in the score of Generalized Anxiety Disorder Scale
timeFrame: 3 months
measure: Change in the score of Hospital Anxiety and Depression Scale
timeFrame: 3 months
Other outcomes:
measure: Change in Chronic Kidney Disease Self-Efficacy Instrument
timeFrame: 3 months
measure: Change in Kidney Disease Behaviors Inventory
timeFrame: 3 months
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Limeng Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.