| CTRI Number |
CTRI/2025/02/080029 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [App based trial] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Mobile application for monitoring of systemic hypertension and Kidney Disease. |
|
Scientific Title of Study
|
A study on effect of App-based monitoring of systemic hypertension and disease progression in patients with Chronic Kidney Disease. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subash Mohan T |
| Designation |
Post Grduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of General Medicine, Saveetha Medical College and
Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9629849333 |
| Fax |
|
| Email |
subashmohan711998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mariraj I |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of General Medicine, Saveetha Medical College and
Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
7299376822 |
| Fax |
|
| Email |
justmariraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subash Mohan T |
| Designation |
Post Grduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of General Medicine, Saveetha Medical College and
Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9629849333 |
| Fax |
|
| Email |
subashmohan711998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai, Tamil nadu,
India, PIN code - 602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai, Tamil nadu, India, PIN code - 602105 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Subash Mohan T |
Saveetha Medical College and Hospital |
Department of General
Medicine, Saveetha
Nagar, Thandalam,
Chennai - 602105
TAMIL NADU
Chennai
TAMIL NADU |
9629849333
subashmohan711998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
App-based monitoring and education of chronic kidney disease patients |
An App based monitoring system is used in addition to standard care in the intervention group This app is mainly based on periodic inputs of data from both the patient as well as the healthcare provider (treating physician or nephrologist). Separate channel for input of data through telephone interviews by the healthcare provider has been created to include illiterate and less technologically enabled patients. Health data relating to symptoms of CKD will be entered through the app on a weekly basis.Laboratory data will be entered on a monthly basis.This Study will be conducted for a duration of six months. Voluntary surveys will be taken at beginning and end of the study period as part of “Assessment of health-related quality of life and its determinants in patients with chronic kidney disease.” Dietary advise and disease information tailored to a specific patient as deemed by the health care provider is provided in the form of text and video supplements. |
| Comparator Agent |
Standard of care therapy |
Patients in the control arm get standard of care therapy according to established therapeutic guidline by the treating physician or nephrologist on OPD basis.Laboratory data will be entered on a monthly basis.This Study will be conducted for a duration of six months.Voluntary surveys will be taken at beginning and end of the study period as part of “Assessment of health-related quality of life and its determinants in patients with chronic kidney disease.” |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18 to 60 years
2.Patients diagnosed to Chronic Kidney disease stage 2 to stage 4
3.Patients diagnosed to have Systemic Hypertension
4.Ability to consent
5.Patients with access to a smart phone
6.Understanding of either English or tamil language
|
|
| ExclusionCriteria |
| Details |
1.Age above 60 years or age less than 18 years
2.Inability to consent
3.Patients on or requiring renal replacement therapy
4.Patients with cognitive disabilities
5.Participation in another interventional study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Decline in eGFR
2.Kidney Quality of Life index |
day 1 ,day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Composite of laboratory data (hemoglobin, urea, potassium, bicarbonate)
2. Mean blood pressure |
0,1st month,2nd month,3rd month,4th month,5th month, 6th month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/02/2025 |
| 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="0"
Months="6"
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
|
This study is done among patients with chronic
kidney disease coming to OPD of general
medicine and nephrology in saveetha medical college and hospital.The
patients recruited for the study are randomized into the control and
intervention gropup.Patients in both groups receive standard guidline
therapy.An App based monitoring system is used in addition to standard care in
the intervention group This app is mainly based on periodic inputs of data from
both the patient as well as the healthcare
provider (treating physician or nephrologist). Separate channel for input of
data through telephone interviews by
the healthcare provider has been created to include illiterate and less technologically enabled patients.
Health data relating to symptoms of CKD will be entered through the app on a
weekly basis.Laboratory data will be entered on a monthly basis. Weekly and
monthly data inputs will be relayed on standardized
graphs,Voluntary surveys will be taken at beginning and end of the study
period as part of “Assessment of health-related quality of life and its
determinants in patients with chronic kidney disease.” Dietary
advise and disease information tailored to a specific patient as deemed by the health care provider
is provided in the form of text and video supplements.
|