| CTRI Number |
CTRI/2025/09/095067 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative exploratory study. |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Designing a mobile application which will help the patients who are on regular dialysis for kidney problem, to decide which food they should eat and which is harmful for them . It will help them to maintain a healthy diet. |
|
Scientific Title of Study
|
Designing a software application for diet management of dialysis patients. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Gupta |
| Designation |
PG Student |
| Affiliation |
MGM School of Biomedical Sciences, MGMIHS, Navi Mumbai |
| Address |
B/703
Saidham Building
carter road no 3
Borivali East
Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400066
India |
| Phone |
9326387639 |
| Fax |
|
| Email |
gneha3557@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Partha Protim Hazarika |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Biomedical Sciences,MGMIHS,NM. |
| Address |
MGM School of Biomedical Sciences
MGMIHS
Sector 1
Kamothe
Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8451012070 |
| Fax |
|
| Email |
partha01medinfo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Partha Protim Hazarika |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Biomedical Sciences,MGMIHS,NM. |
| Address |
MGM School of Biomedical Sciences
MGMIHS
Sector 1
Kamothe
Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8451012070 |
| Fax |
|
| Email |
partha01medinfo@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM School Of Biomedical Sciences, MGMIHS , Navi Mumbai. |
|
|
Primary Sponsor
|
| Name |
Neha Gupta |
| Address |
B/703,Saidham Building, Carter road no 3, Borivali East, Mumbai 400066 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Partha Protim Hazarika |
MGM Hospital , Kamothe |
Department of Clinical Nutrition, Room no. 216, Allied Health Division,
Sector 1 ,
Navi Mumbai 410209.
Raigarh
MAHARASHTRA |
8451012070
partha01medinfo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahatma Gandhi Mission Dental College & Hospital. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
i. Nutritionists who primary take care of dialysis patients.
ii. Dialysis technicians.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i. Nutritionists who primary take care of dialysis patients.
ii. Dialysis technicians.
|
|
| ExclusionCriteria |
| Details |
Staff unwilling to share relevant data or participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome 1: To identify user requirement through qualitative analysis among the nutritionists taking care of dialysis patients.
Outcome 2: To design and develop a digital application for diet management of dialysis patient as per the requirement gathered in outcome 1.
|
1) 3 months
2) 9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Designing a software application for diet management of dialysis patients.Purpose: To design and develop a software application that facilitates diet management for dialysis patients, specifically tailored for nutritionists.
This research aims to develop a diet management software application tailored for dialysis patients. The study will be conducted in two phases. In the first phase, a qualitative exploratory study will be carried out at a tertiary care hospital to understand the dietary challenges faced by dialysis patients. In-depth interviews will be conducted with nutritionists and dialysis technicians to gather insights. Thematic analysis will be used to identify key nutritional requirements and workflow gaps in current diet planning practices. In the second phase, a customized software application will be designed and developed based on the findings. The application will include role-based views for nutritionists and dialysis technicians, and will be tested in a simulated dialysis setup. Usability testing will be conducted with nutrition department staff to evaluate the application’s effectiveness, user experience, and relevance to clinical practice. The final product aims to support personalized diet planning, improve workflow efficiency, and enhance patient care in dialysis settings. |