Validation and Evaluation of a Newly Developed Mobile Diet App for Enhancing Dietary Adherence for Patients With Chronic Kidney Disease (CKD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Serum Kidney Function Test
研究概览
简要总结
A 12-week, prospective, multicenter, open-label pilot randomized controlled trial (RCT) will be carried out to determine the feasibility, acceptability and potential clinical efficacy of a newly developed mobile diet app among CKD populations at different stages in Malaysia. Participants will be randomly assigned into either (i) intervention group (mobile diet app) or (ii) control group (dietary counseling using conventional pamphlet).
详细描述
General Objective: To evaluate a newly developed mobile diet app in enhancing dietary adherence for patients with chronic kidney disease.
Specific Objectives:
- To validate the newly developed mobile diet app for patient with chronic kidney disease.
- To determine the feasibility and acceptability of this newly developed mobile diet app among patients with chronic kidney disease.
- To evaluate the preliminary efficacy of the newly developed mobile diet app in enhancing dietary adherence in patients with chronic kidney disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed CKD / eGFR < 60 ml/min/1.73m2 for ≥ 3 months (only applicable to pre-dialysis patients.
- •Undergone maintenance dialysis for at least 3 months (only applicable to dialysis patients)
- •Possessing smartphone and is willing to use health app
- •Alert and oriented
- •At least 18 years of age
排除标准
- •Inability to use the smartphone app (e.g. due to vision problems)
- •Hard to comply with home monitoring (e.g. suffering from anxiety or depression)
- •Refuse to comply with dietary prescription
- •Patients who participate in other study at the same time
- •Patients who have participated in another research study involving an investigational product in the past 12 weeks preceding enrollment.
- •Planning for kidney transplant over the study duration.
- •Female patients who are pregnant, lactating or planning a pregnancy during the course of the trial.
- •Participants who are receiving nutritional support (i.e. enteral and intra-venous route).
- •Participants who are currently receiving active treatment for cancer
研究组 & 干预措施
Counseling + Renal Diet App
Subjects in the intervention group will receive an individualized dietetic counseling from the researcher aided with the newly developed renal diet app for educative purpose and aiding tool to enhance the dietary adherence among CKD patients
干预措施: Counseling (Other)
Counseling + Renal Diet App
Subjects in the intervention group will receive an individualized dietetic counseling from the researcher aided with the newly developed renal diet app for educative purpose and aiding tool to enhance the dietary adherence among CKD patients
干预措施: Renal Diet App (Other)
Counseling + Printed Nutrition Pamphlet
Individualized dietetic counseling aided with printed nutrition pamphlet prepared by Ministry of Health, Malaysia
干预措施: Counseling (Other)
Counseling + Printed Nutrition Pamphlet
Individualized dietetic counseling aided with printed nutrition pamphlet prepared by Ministry of Health, Malaysia
干预措施: Printed Nutrition Pamphlet (Other)
结局指标
主要结局
Serum Kidney Function Test
时间窗: 3 months
Routine collected biochemical results from the patients' medical records: - urea, sodium, chloride, potassium and creatinine will be measured in mmol/L
Serum Blood Sugar Profile
时间窗: 2 weeks
Routine collected biochemical results from the patients' medical records and blood sugar (mmol/L) also will be recorded if patient had done self-monitoring blood glucose at home
Glomerular Filtration Rate (eGFR)
时间窗: 3 months
Estimated glomerular filtration rate (eGFR) will be recorded in of mL/min/1.73m2.
Serum Hemoglobin A1C Test
时间窗: 3 months
Routine collected biochemical results from the patients' medical records for HbA1C (%)
Albuminuria
时间窗: 12 weeks
Routine collected urine analysis to measure urine albumin (mg) if there is presence of albumin or protein
Dietary History
时间窗: 6 weeks
Three-day diet records (3DDR) : 2 days weekdays + 1 weekend / dialysis and non-dialysis day. Measured unit is in kilocalories (kcal)/day
Dietary Adherence
时间窗: 6 weeks
End Stage Renal Disease Adherence Questionnaire (ESRD-AQ): - validated questionnaires which consists of 4 subscales pertaining dialysis, medication, dietary and fluid adherences. Patients will need to rate their fluid and dietary adherence on a numerical rating scale which composed of 0% (None of the time) to 100% (All of the time).
次要结局
- Acceptability: User Acceptance test (UAT)(12 weeks)
- Nutrition Literacy(12 weeks)
- Dietary Knowledge(12 weeks)
- Feasibility of the app: interview(12 weeks)
- Users Satisfaction: Likert scale(12 weeks)
- Health Behaviour(12 weeks)
- Nutritional Status(12 weeks)
研究者
Jazlina binti Syahrul
Principle Investigator [Dietitian]
Universiti Putra Malaysia