Fostering Self-Empowerment in Kidney Disease Patients Through Food Choice Mapping: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Physical Health-Related Quality of Life
研究概览
简要总结
This project aims to develop mapping of food choices available for chronic kidney disease (CKD) patients when dining out in Singapore. Following the mapping, a mobile application will be developed based on renal dining out food map mobile application (RENDOFOMAP) and trialed on patients with CKD. The specific aims of the project include:
- Mapping out food choices suitable for patients with CKD when dining out in Singapore which will eventually be translated into a mobile application incorporating simple AI functionality.
- To evaluate the impact of using RENDOFOMAP on self-empowerment, quality of life, nutritional status, and serum biochemistry in patients with CKD.
- To evaluate the acceptability and user experience of RENDOFOMAP
Participants with CKD will use the newly developed mobile application to find out if there is improvement in self-empowerment, quality of life, nutritional status, and serum biochemistry.
详细描述
Diet is integral in CKD management; however, it is not sustainable for patients in the long term if there is solely emphasis on food restrictions without providing knowledge on modifying food choices to allow enjoyment. Thus, a strategic nutritional education approach needs to be adopted to maximise cost-effectiveness.
Patients' self-empowerment is gaining recognition as a means to optimise hospital resource utilisation, reduce healthcare costs, and decrease patients' dependency on medical services. This is particularly relevant for patients with chronic kidney disease (CKD), who are required to adhere to a disease management regimen that often conflicts with their pre-diagnosis lives and priorities.
In recent years, mobile applications have emerged as a popular platform for delivering nutrition education programs. Research indicates that mobile applications designed to engage patients and promote self-management of CKD show promise in improving adherence to dietary restrictions related to sodium, potassium, phosphorus, protein, calories, and fluid intake. Some of these applications offer a range of features but will still need to be reviewed by dietitians during face-to-face consultations. This in-depth approach, while beneficial, may not fully optimise time efficiency for dietitians.
Thus, there is an impetus to create an improved mobile application for CKD nutritional management to allow patients to individualise food choices, on top of charting food intake in the form of food diary. Patients can be trained to use the application during dietetics session which can eventually help reduce time spent for each session thereby improving dietitians' workload.
The proposed application will also incorporate some preliminary Artificial Intelligence (AI) to offer personalised food choices for patients. This feature is expected to further enhance the user-friendliness and convenience of the application, thereby promoting its usage and empowerment among CKD patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are fluent in English. This is necessary to ensure clear communication and understanding of study procedures and materials.
- •Adequate proficiency in using smartphone i.e. downloading app, taking photo, completing e-forms within the mobile applications. This is essential for participants to effectively use the mobile application being tested.
- •Diagnosed with CKD Stage 3B-
- •This targets the specific patient population that the study aims to benefit.
排除标准
- •Only fluent in languages other than English. This could hinder effective communication and understanding of the study.
- •Diagnosis of cognitive deficit or neurological disorder. These conditions could impair the ability to follow study procedures or provide reliable data.
- •Uncontrolled diabetes (HbA1c>8.5%). This condition could introduce additional health risks and confound study results.
- •Recent hypoglycemic episodes. This could pose a safety risk during the study.
- •Newly initiated on dialysis or planning for dialysis within the next 6 months. These patients may have rapidly changing health conditions that could affect study outcomes.
- •Decompensated liver cirrhosis. This condition could complicate the interpretation of study results.
- •Pregnant and lactating. These conditions could introduce additional variables that affect study outcomes.
- •Inability to provide consent. This ensures that all participants can legally and ethically participate in the study
结局指标
主要结局
Physical Health-Related Quality of Life
时间窗: Baseline to the end of study at 12-16 weeks
Physical Health-Related Quality of Life At baseline and Week 12-16, physical health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). The Physical Component Summary (PCS) score ranges from 5 to 20, with lower scores indicating better health-related quality of life and higher scores indicating poorer health-related quality of life.
Mental Health-Related Quality of Life
时间窗: Baseline to the end of study at 12-16 weeks
At baseline and Week 12-16, mental health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). The Mental Component Summary (MCS) score ranges from 12 to 45, with lower scores indicating better health-related quality of life and higher scores indicating poorer health-related quality of life.
Modified Nutrition-related Empowerment Scale
时间窗: Baseline to the end of study at 12-16 weeks
At baseline and Week 12-16, nutrition-related empowerment will be assessed using a modified version of the Korean Health Empowerment Scale (K-HES). The scale consists of 8 items scored from 1 (Strongly Disagree) to 5 (Strongly Agree). Item scores are summed to generate a total score ranging from 8 to 40, with higher scores indicating greater nutrition-related empowerment and self-management capacity.
Ease of Adherence to Diet Plan When Eating Out
时间窗: Baseline to the end of study at 12-16 weeks
Participants will rate the ease of adhering to their prescribed diet plan when eating out using a 5-point scale ranging from 1 (very difficult) to 5 (very easy). Higher scores indicate greater ease of dietary adherence.
Food Diary Completion Rate
时间窗: Baseline to the end of study at 12-16 weeks
Participant engagement with the nEAT mobile application will be assessed by the proportion of scheduled food diary entries completed during the intervention period. Food diary completion rate (%) = (Number of completed food diary entries ÷ Total number of scheduled food diary entries) × 100. A food diary entry is considered completed when the participant records the required dietary information for the scheduled eating occasion within the nEAT mobile application
次要结局
- Body Weight Change(Baseline to the end of study at 12-16 weeks)
- Percentage Weight Change(Baseline to the end of study at 12-16 weeks)
- Body Mass Index (BMI)(Baseline to the end of study at 12-16 weeks)
- Nutritional Status [Subjective Global Assessment (SGA)}(Baseline to the end of study at 12-16 weeks)
- Ease of Adherence to Diet Plan When Eating at Home(Baseline to the end of study at 12-16 weeks)
- Energy Intake Relative to Estimated Requirements(Baseline to the end of study at 12-16 weeks)
- Protein Intake Relative to Estimated Requirements(Baseline to the end of study at 12-16 weeks)
- Sodium Intake Relative to Estimated Requirements(Baseline to the end of study at 12-16 weeks)
- Phosphorus Intake Relative to Estimated Requirements(Baseline to the end of study at 12-16 weeks)
- Potassium Intake Relative to Estimated Requirements(Baseline to the end of study at 12-16 weeks)
研究者
Gary Tung Lin Chiah
Senior Lecturer
Singapore Institute of Technology