| CTRI Number |
CTRI/2025/11/097183 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study among patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate the use of a mobile-based application ‘Breath Track’ as an intervention tool for monitoring symptoms and treatment adherence,
and to assess its effectiveness in improving compliance and clinical outcomes.
|
|
Scientific Title of Study
|
BREATH TRACK A Digital Therapeutic Platform for Real Time Assessment of Treatment Compliance and Response Monitoring in Chronic Obstructive Pulmonary Disease (COPD) Patients to Bridge Gaps Between Patients and Healthcare Providers |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharmavaram singamsetty moukthi ka |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital,Saveetha institute of medical and technical sciences |
| Address |
Room no.421 ,Department of Respiratory Medicine,Saveetha Medical college and hospital,Saveetha institute of medical and technical sciences,Saveetha nagar,Thandalam,Chennai,India
Saveetha Medical college and hospital,Saveetha institute of medical and technical sciences
Chennai
TAMIL NADU
602105
India |
| Phone |
9663952802 |
| Fax |
|
| Email |
moukthikaroyal2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sowmitha S G |
| Designation |
Assistant professor |
| Affiliation |
Saveetha medical college and hospital,Saveetha institute of medical and technical sciences |
| Address |
Room no.421 ,Department of Respiratory Medicine,Saveetha Medical college and hospital,Saveetha institute of medical and technical sciences,Saveetha nagar,Thandalam,Chennai,India
Saveetha Medical college and hospital,Saveetha institute of medical and technical sciences
Chennai
TAMIL NADU
602105
India |
| Phone |
9663952802 |
| Fax |
|
| Email |
sowmitha.shankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dharmavaram singamsetty moukthika |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital,Saveetha institute of medical and technical sciences |
| Address |
Room no.421 ,Department of Respiratory Medicine,Saveetha Medical college and hospital,Saveetha institute of medical and technical sciences,Saveetha nagar,Thandalam,Chennai,India
Saveetha Medical college and hospital,Saveetha institute of medical and technical sciences
Chennai
TAMIL NADU
602105
India |
| Phone |
9663952802 |
| Fax |
|
| Email |
moukthikaroyal2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical college and hospital,Saveetha nagar,Thandalam,chennai 602105 |
|
|
Primary Sponsor
|
| Name |
Dharmavaram singamseety moukthi ka |
| Address |
Saveetha Medical college and hospital,Saveetha institute of medical and technical sciences,saveetha nagar,thandala,,chennai,indiaTAMILNADU 602105
INDIA |
| 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 |
| Dharmavaram Singamsetty Moukthi ka |
Saveetha Medical college hospital |
Room no 421 ,Department of Respiratory Medicine,Saveetha Medical College and Hospital,Saveetha nagar,thandalam,chennai,tamilnadu
Chennai
TAMIL NADU |
9663952802
moukthikaroyal2@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: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Able and willing to provide informed consent.
2. Access to a smartphone/tablet (or caregiver available to assist with app use).
3. Willing to comply with study procedures, follow-up visits, and digital monitoring.
4. Confirmed diagnosis of COPD as per GOLD guidelines |
|
| ExclusionCriteria |
| Details |
1. Non-COPD Respiratory Conditions (to avoid confounding)
2. Acute COPD exacerbation, pneumonia, or hospitalization within the past 4–6 weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Enhance patient compliance
Monitor treatment response
Facilitate communication
Educate patient |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Healthcare Utilization
Reduction in number of acute exacerbations and hospitalizations.
Reduction in emergency room visits related to COPD.
Quality of Life Measures
Improvement in health-related quality of life using validated tools (e.g., St. George’s Respiratory Questionnaire).
Improvement in daily activity and exercise tolerance.
App Usability & Patient Satisfaction
Patient-reported ease of use, acceptance, and satisfaction with the application |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/12/2025 |
| 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 Yet Recruiting |
| 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
|
The "Breath Track" research project aims to develop a mobile application specifically designed for the management of Chronic Obstructive Pulmonary Disease (COPD). The primary goal is to enhance patient compliance and monitor treatment responses, thereby bridging the gap between patients and healthcare providers.
The project will involve the design and implementation of features that allow patients to log symptoms, track medication adherence, and access educational resources about COPD management.
This research will assess the app’s impact on patient outcomes, healthcare utilization, and overall quality of life. Through data collection and analysis, the project aims to contribute valuable insights into effective COPD management strategies, ultimately fostering a more proactive approach to chronic disease care. The findings may inform future innovations in digital health and improve patient-provider communication models in the management of chronic illnesses. |