Status:
NOT_YET_RECRUITING
Clinical Effectiveness of MyNutriKidney®
Lead Sponsor:
Universiti Putra Malaysia
Collaborating Sponsors:
International Society of Nephrology
Conditions:
Chronic Kidney Disease Stage 3
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a 6-month, pragmatic, multi-center, sequentially recruited, stratified, open-label randomized controlled trial (RCT) conducted in Malaysia. It aims to determine the clinical effectivenes...
Detailed Description
General Objective: To evaluate the clinical effectiveness of supplementing standard care with the MyNutriKidney® mobile application compared to standard care alone in improving dietary adherence and ...
Eligibility Criteria
Inclusion
- Participants must meet all of the following inclusion criteria and none of the exclusion criteria to be eligible for enrolment into the study.
- Clinically diagnosed Chronic Kidney Disease (CKD):
- 1. eGFR \< 60 ml/min/1.73m² for ≥ 3 months (applicable to pre-dialysis patients, Stages 3-5)
- Aged 18 years or older.
- Possesses a personal smartphone compatible with the MyNutriKidney® application and is willing to use the health app if randomized to the intervention group.
- Alert and oriented, and deemed capable of providing informed consent and participating in study procedures.
- Able to communicate and understand study procedures in English, Bahasa Melayu, or Mandarin.
Exclusion
- Inability to effectively use the smartphone application due to significant impairments (e.g., severe visual or motor problems).
- Smartphone owned by the participant does not meet the minimum technical requirements for the MyNutriKidney® application installation and operation
- Presence of significant cognitive impairment or severe psychological conditions (e.g., uncontrolled anxiety or depression) likely to impede consistent participation or adherence to study requirements.
- Known unwillingness or inability to comply with core study procedures, including dietary assessment components.
- Concurrent participation in another interventional research study.
- Participation in another research study involving an investigational product in the 12 weeks preceding potential enrollment.
- Female participants who are pregnant, currently lactating, or planning a pregnancy during the course of the trial.
- Currently receiving primary nutritional support via enteral tube feeding or parenteral (intra-venous) nutrition.
- Currently receiving active treatment for cancer (e.g., chemotherapy, radiotherapy).
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06956872
Start Date
July 1 2025
End Date
February 1 2027
Last Update
May 4 2025
Active Locations (1)
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1
Sultan Idris Shah Hospital, Serdang
Kajang, Selangor, Malaysia, 43000