Status:

UNKNOWN

Validation and Evaluation of a Newly Developed Mobile Diet App

Lead Sponsor:

Universiti Putra Malaysia

Conditions:

Chronic Kidney Diseases

Chronic Kidney Disease stage3

Eligibility:

All Genders

18+ years

Phase:

NA

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 devel...

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 mobi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 15 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 30 2023

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT04336033

Start Date

February 15 2023

End Date

April 30 2023

Last Update

January 27 2023

Active Locations (1)

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Hospital Serdang

Serdang, Selangor, Malaysia, 43000