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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Renal Disease

Intervention / Treatment
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* Behavioral: Mobile Application for Dietary Management


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Application Intervention<br>Participants in this arm will receive mobile application dietary intervention as well as usual CKD dietary care. | Behavioral: Mobile Application for Dietary Management<br>* 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.<br>|
| No Intervention: Care as Usual<br>Participants in this arm will receive usual CKD dietary care. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Renal Disease, Dietary Management, Mobile Application