A Mobile Application Based Dietary Self Management Intervention in Chinese Chronic Kidney Disease Patients: a Multi-Center Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 9,863
- 试验地点
- 1
- 主要终点
- Change in Proteinuria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Proteinuria
时间窗: 3 months
spot urine before and after intervention period
Diet Quality
时间窗: 3 months
Calculated by Chinese Healthy Eating Index
Change in Disease Related Quality of life
时间窗: 3 months
Measured by Kidney Disease Quality of Life 36-Short Form questionnaire
change in estimated Glomerular Filtration Rate (eGFR)
时间窗: 3 months
blood draw (fasting) before and after intervention period
Dietary Intake
时间窗: 3 months
Dietary intake of calorie, protein, sodium, potassium and phosphate evaluated by three-day diet records (3DDR)
Blood Pressure
时间窗: 3 months
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.
Change in Self-Efficacy for Managing Chronic Disease Scale
时间窗: 3 months
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
Change in Perceived Medical Condition Self-Management Scale (PMCSMS）
时间窗: 3 months
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
次要结局
- Acceptability of the Application(3 months)
- Urine Sodium/potassium Ratio(3 months)
- Kidney Nutrition Knowledge, Attitude and Practice(3 months)
- Adoption(3 months)
- Blood Chemistry (Potassium, Bicarbonate, Phosphate)(3 months)
- Salt Taste Threshold(3 months)
- Adherence(3 months)
- Change in the score of Generalized Anxiety Disorder Scale(3 months)
- Change in the score of Hospital Anxiety and Depression Scale(3 months)
研究者
Limeng Chen
Director, Department of Nephrology
Peking Union Medical College Hospital