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

NCT04940819 | Unknown

• 1 other identifier: CRISS-Diet
• Study Type: interventional
• Target: 9,863
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Disease

Keywords

Chronic Renal Disease; Dietary Management; Mobile Application

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (9)

• Blood Chemistry (Potassium, Bicarbonate, Phosphate)

  3 months

• Urine Sodium/potassium Ratio

  3 months

• Salt Taste Threshold

  3 months

• Kidney Nutrition Knowledge, Attitude and Practice

  3 months

• Acceptability of the Application

  3 months

Other Outcomes (2)

• Change in Chronic Kidney Disease Self-Efficacy Instrument

  3 months

• Change in Kidney Disease Behaviors Inventory

  3 months

Study Arms (2)

Mobile Application Intervention

EXPERIMENTAL

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

Behavioral: Mobile Application for Dietary Management

Care as Usual

NO INTERVENTION

Participants in this arm will receive usual CKD dietary care.

Interventions

Mobile Application for Dietary Management 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.

Mobile Application Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (3)

• 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.

  PMID: 22386035 BACKGROUND

• 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.

  PMID: 31425608 BACKGROUND

• 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.

  PMID: 32478665 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Diet

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Limeng Chen, MD, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xixi Zheng, MD

CONTACT

+8613521145030; zxxpumch@163.com

Peng Xia, MD

CONTACT

+8613811684903; 7-xp@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Nephrology

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 28, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)