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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9,863
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.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Dietary Intake
Dietary intake of calorie, protein, sodium, potassium and phosphate evaluated by three-day diet records (3DDR)
Time frame: 3 months
Diet Quality
Calculated by Chinese Healthy Eating Index
Time frame: 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.
Time frame: 3 months
change in estimated Glomerular Filtration Rate (eGFR)
blood draw (fasting) before and after intervention period
Time frame: 3 months
Change in Proteinuria
spot urine before and after intervention period
Time frame: 3 months
Change in Disease Related Quality of life
Measured by Kidney Disease Quality of Life 36-Short Form questionnaire
Time frame: 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
Time frame: 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
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Time frame: 3 months
Blood Chemistry (Potassium, Bicarbonate, Phosphate)
blood draw (fasting) before and after intervention period
Time frame: 3 months
Urine Sodium/potassium Ratio
Measured by spot urine at baseline and after intervention
Time frame: 3 months
Salt Taste Threshold
Salt taste threshold measured using salt-impregnated test strips before and after the intervention period
Time frame: 3 months
Kidney Nutrition Knowledge, Attitude and Practice
Measured by self developed questionnaire about knowledge, attitude and practice in kidney disease specified diet
Time frame: 3 months
Acceptability of the Application
Measured by user acceptability survey and semistructured interviews conducted in participants and nephrologists
Time frame: 3 months
Adherence
Total number of diet diary logged by participants over complete study period (more than 60% logged is deemed good adherence)
Time frame: 3 months
Adoption
Measured by percentage of complete dietary log in days will be counted (\>1200kcal deemed as complete log)
Time frame: 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
Time frame: 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
Time frame: 3 months