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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Application Intervention | Experimental | Participants in this arm will receive mobile application dietary intervention as well as usual CKD dietary care. |
|
| Care as Usual | No Intervention | Participants in this arm will receive usual CKD dietary care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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） |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xixi Zheng, MD | Contact | +8613521145030 | zxxpumch@163.com | |
| Peng Xia, MD | Contact | +8613811684903 | 7-xp@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Limeng Chen, MD, PhD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22386035 | Background | 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. | |
| 31425608 |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
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 |
| 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 |
Kidney Disease Behaviors Inventory before and after intervention
| 3 months |
| 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. |
| 32478665 | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |