Chronic Kidney Diseases Clinical Trial
Official title:
Validation and Evaluation of a Newly Developed Mobile Diet App for Enhancing Dietary Adherence for Patients With Chronic Kidney Disease (CKD)
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).
Status | Recruiting |
Enrollment | 90 |
Est. completion date | April 30, 2023 |
Est. primary completion date | March 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Clinically diagnosed CKD / eGFR < 60 ml/min/1.73m2 for = 3 months (only applicable to pre-dialysis patients. 2. Undergone maintenance dialysis for at least 3 months (only applicable to dialysis patients) 3. Possessing smartphone and is willing to use health app 4. Alert and oriented 5. At least 18 years of age Exclusion Criteria: 1. Inability to use the smartphone app (e.g. due to vision problems) 2. Hard to comply with home monitoring (e.g. suffering from anxiety or depression) 3. Refuse to comply with dietary prescription 4. Patients who participate in other study at the same time 5. Patients who have participated in another research study involving an investigational product in the past 12 weeks preceding enrollment. 6. Planning for kidney transplant over the study duration. 7. Female patients who are pregnant, lactating or planning a pregnancy during the course of the trial. 8. Participants who are receiving nutritional support (i.e. enteral and intra-venous route). 9. Participants who are currently receiving active treatment for cancer |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital Serdang | Serdang | Selangor |
Lead Sponsor | Collaborator |
---|---|
Universiti Putra Malaysia |
Malaysia,
Ahmad, G., Leong, G. B., Ngo, L. Y., Meng, O. L., & Guat, L. D. (2016). 24th Report of the Malaysian Dialysis and Transplant Registry 2016. National Renal Registry Malaysia
Campbell J, Porter J. Dietary mobile apps and their effect on nutritional indicators in chronic renal disease: A systematic review. Nephrology (Carlton). 2015 Oct;20(10):744-751. doi: 10.1111/nep.12500. — View Citation
Chan YM, Zalilah MS, Hii SZ. Determinants of compliance behaviours among patients undergoing hemodialysis in Malaysia. PLoS One. 2012;7(8):e41362. doi: 10.1371/journal.pone.0041362. Epub 2012 Aug 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glomerular Filtration Rate (eGFR) | Estimated glomerular filtration rate (eGFR) will be recorded in of mL/min/1.73m2. | 3 months | |
Primary | Serum Kidney Function Test | Routine collected biochemical results from the patients' medical records:
- urea, sodium, chloride, potassium and creatinine will be measured in mmol/L |
3 months | |
Primary | Serum Hemoglobin A1C Test | Routine collected biochemical results from the patients' medical records for HbA1C (%) | 3 months | |
Primary | Serum Blood Sugar Profile | 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 | 2 weeks | |
Primary | Albuminuria | Routine collected urine analysis to measure urine albumin (mg) if there is presence of albumin or protein | 12 weeks | |
Primary | Dietary History | Three-day diet records (3DDR) : 2 days weekdays + 1 weekend / dialysis and non-dialysis day. Measured unit is in kilocalories (kcal)/day | 6 weeks | |
Primary | Dietary Adherence | 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). |
6 weeks | |
Secondary | Feasibility of the app: interview | The feasibility of the app will be measured by the app usage. Study participants will be interviewed for app usage in term of frequency (e.g. in average how many days of usage in a week) and extent of its usage (e.g. how much time has spent on the app in a day). The intervention (mobile diet app) is consider feasible if the subject used the app more than 50% of study duration which is 42 days (6 weeks). | 12 weeks | |
Secondary | Acceptability: User Acceptance test (UAT) | Acceptability of the app will be measured using User Acceptance test (UAT). It consisted of 11 items and each item was rated on a 5-point Likert scale (1 = Strongly disagree, 3 = neutral, and 5 = Strongly agree). | 12 weeks | |
Secondary | Users Satisfaction: Likert scale | The evaluation questionnaire included 7 items evaluated using a five-point Likert scale (1 = Strongly disagree, 3 = neutral, and 5 = Strongly agree) on the composition of the app, on the design and layout of the app, and overall satisfaction. | 12 weeks | |
Secondary | Health Behaviour | A set of self-developed items will be used to assess the patient's perceptions of dietary adherence based on HBM constructs. Content validity have been done by 3 experts with the reported S-CVI/UA of 0.93. This part consisted of 28 items derived from available literatures, assessing different constructs of HBM | 12 weeks | |
Secondary | Nutrition Literacy | A dialysis-specific nutrition-related health literacy has been developed based on health literacy theory model (Sørensen et al., 2012) by the researchers and validated among HD patients with the content validity measured by S-CVI/AVE of 0.96 and construct validity measured by average variance extract (AVE) of 0.589 as well as composite reliability of 0.877 (unpublished data). | 12 weeks | |
Secondary | Nutritional Status | Anthropometry data will be collected by researchers at 2 time points, baseline (V0) and study end-point (V2). Malnutrition inflammation score (MIS) will be used to assess patient's nutritional status (Kalantar-Zadeh, Kopple, Block & Humphreys, 2001). | 12 weeks | |
Secondary | Dietary Knowledge | The kidney disease-related dietary knowledge questionnaire was modified from (Durose et al., 2004) based on the Malaysian MNT Guidelines for CKD, (MDA, 2005) which was adopted from the K-DOQI guidelines (NKF 2000; NKF 2003). | 12 weeks |
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