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

A Mobile Application Based Dietary Self Management Intervention in Chinese Chronic Kidney Disease Patients: a Multi-Center Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Renal Disease
• Intervention / Treatment: Behavioral: Mobile Application for Dietary Management

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.

• Study Type: Interventional
• Enrollment (Anticipated): 9863
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xixi Zheng, MD; Phone Number: +8613521145030; Email: zxxpumch@163.com
• Study Contact Backup: Name: Peng Xia, MD; Phone Number: +8613811684903; Email: 7-xp@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
      • Contact: Xixi Zheng, MD; Phone Number: +8613521145030; Email: zxxpumch@163.com
      • Contact: Peng Xia, MD; Phone Number: +8613811684903; Email: 7-xp@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile Application Intervention; Participants in this arm will receive mobile application dietary intervention as well as usual CKD dietary care.	Behavioral: 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.
No Intervention: Care as Usual; Participants in this arm will receive usual CKD dietary care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Intake	Dietary intake of calorie, protein, sodium, potassium and phosphate evaluated by three-day diet records (3DDR)	3 months
Diet Quality	Calculated by Chinese Healthy Eating Index	3 months
Blood Pressure	Measure BP in office visits after the intervention period. Changes in antihypertensive medication requirements (total number, dose, class) will be collected from participants and verified with hospital records.	3 months
change in estimated Glomerular Filtration Rate (eGFR)	blood draw (fasting) before and after intervention period	3 months
Change in Proteinuria	spot urine before and after intervention period	3 months
Change in Disease Related Quality of life	Measured by Kidney Disease Quality of Life 36-Short Form questionnaire	3 months
Change in Self-Efficacy for Managing Chronic Disease Scale	Score of Self-Efficacy for Managing Chronic Disease Scale (6 items, each measured on a 1-10 likert scale, higher score indicate better self-efficacy) before and after intervention period	3 months
Change in Perceived Medical Condition Self-Management Scale (PMCSMS）	Measured by Perceived Medical Condition Self-Management Scale (8-item CKD-specific version of the PMCSMS, each item is scored on a 1-5 likert scale, with higher score indicating better self management on item 3/4/5/8 and lower score indicating better self management on item 1/2/6/7) before and after intervention	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Chemistry (Potassium, Bicarbonate, Phosphate)	blood draw (fasting) before and after intervention period	3 months
Urine Sodium/potassium Ratio	Measured by spot urine at baseline and after intervention	3 months
Salt Taste Threshold	Salt taste threshold measured using salt-impregnated test strips before and after the intervention period	3 months
Kidney Nutrition Knowledge, Attitude and Practice	Measured by self developed questionnaire about knowledge, attitude and practice in kidney disease specified diet	3 months
Acceptability of the Application	Measured by user acceptability survey and semistructured interviews conducted in participants and nephrologists	3 months
Adherence	Total number of diet diary logged by participants over complete study period (more than 60% logged is deemed good adherence)	3 months
Adoption	Measured by percentage of complete dietary log in days will be counted (>1200kcal deemed as complete log)	3 months
Change in the score of Generalized Anxiety Disorder Scale	Measured by Generalized Anxiety Disorder Scale (a 7-item self-report scale. Items are rated on a 4-point Likert-scale with 0 = not at all to 3 = nearly every day ) before and after intervention	3 months
Change in the score of Hospital Anxiety and Depression Scale	Measured by Hospital Anxiety and Depression Scale (14 items each rated on a 0-3 score, with higher score indicating worse anxiety or depression symptoms) before and after intervention	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Chronic Kidney Disease Self-Efficacy Instrument	Score of Chronic Kidney Disease Self-Efficacy Instrument before and after intervention period	3 months
Change in Kidney Disease Behaviors Inventory	Kidney Disease Behaviors Inventory before and after intervention	3 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Limeng Chen, MD, PhD, Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2012 Aug 18;380(9842):650.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Mobile Application; Chronic Renal Disease; Dietary Management
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: CRISS-Diet

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No