Validation and Evaluation of a Newly Developed Mobile Diet App for Enhancing Dietary Adherence for Patients With Chronic Kidney Disease (CKD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- Universiti Putra Malaysia
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Serum Kidney Function Test
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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).
Detailed Description
General Objective: To evaluate a newly developed mobile diet app in enhancing dietary adherence for patients with chronic kidney disease. Specific Objectives: 1. To validate the newly developed mobile diet app for patient with chronic kidney disease. 2. To determine the feasibility and acceptability of this newly developed mobile diet app among patients with chronic kidney disease. 3. To evaluate the preliminary efficacy of the newly developed mobile diet app in enhancing dietary adherence in patients with chronic kidney disease
Investigators
Jazlina binti Syahrul
Principle Investigator [Dietitian]
Universiti Putra Malaysia
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Serum Kidney Function Test
Time Frame: 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
Time Frame: 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)
Time Frame: 3 months
Estimated glomerular filtration rate (eGFR) will be recorded in of mL/min/1.73m2.
Serum Hemoglobin A1C Test
Time Frame: 3 months
Routine collected biochemical results from the patients' medical records for HbA1C (%)
Albuminuria
Time Frame: 12 weeks
Routine collected urine analysis to measure urine albumin (mg) if there is presence of albumin or protein
Dietary History
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
- 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)