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CTRI Number  CTRI/2025/03/082346 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 13/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Novel Mobile Application for Heart Failure Assessment and Management. 
Scientific Title of Study   A Novel Mobile Application for an Integrated Approach to Cardiac Failure Assessment and Management 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR TIRUMANI RAGHU RAM PRASAD 
Designation  Post Graduate, General Medicine 
Affiliation  Saveetha Medical College and Hospital 
Address  Room no:01, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu Kancheepuram TAMIL NADU 602105 India

Kancheepuram
TAMIL NADU
602105
India 
Phone  07382584445  
Fax    
Email  raghuramtrmn143@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR KANNAN 
Designation  Professor, General Medicine 
Affiliation  Saveetha Medical College and Hospital 
Address  Room no.1, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai

Kancheepuram
TAMIL NADU
602105
India 
Phone  9710071284  
Fax    
Email  endork@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR KANNAN 
Designation  Professor, General Medicine 
Affiliation  Saveetha Medical College and Hospital 
Address  Room no. 1, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai


TAMIL NADU
602105
India 
Phone  9710071284  
Fax    
Email  endork@yahoo.com  
 
Source of Monetary or Material Support  
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai, TAMIL NADU, 602105 
 
Primary Sponsor  
Name  Saveetha Medical College and Hospital 
Address  Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu 602105 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tirumani Raghu Ram Prasad  Saveetha Medical College and Hospital  Room no. 1, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU 		 07382584445

raghuramtrmn143@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I501||Left ventricular failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A Novel Mobile Application for Cardiac Failure patients  A Novel Mobile Application for Integrated Cardiac Failure Assessment and Management as compared with a Conventional method of follow-up for Heart failure over a period of 3 months in 50 patients 
Comparator Agent  Conventional Follow up in Cardiac Failure Patients  Conventional method of follow up in Cardiac Failure Patients in terms of Symptom management, Medication adherence, Number of hospitalizations, Quality of Life and Investigations trends over a period of 3 months in 50 patients 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Diagnosed with heart failure by a qualified healthcare professional and regularly visiting the hospital clinic for medical follow-ups.
2. Between 20 to 75 years of age.
3. Able to use a smartphone app.
4. Able to perform regular physical activity according to the patients self-identification and the judgment of their primary cardiologist
5. Willingness to provide informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Age: Participants under the age of 20 years.
2. Patients with severe cognitive impairment or inability to comprehend and use the mobile application effectively.
3. Patients with a terminal illness or life expectancy of less than six months.
4. Patients currently enrolled in other clinical trials or research studies related to cardiac failure management.
5. Patients with recent major cardiovascular events or surgeries within the past three months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Improved symptom management, enhanced medication adherence, increased patient engagement, and better communication with healthcare providers  At baseline and three months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reduced complications
2. Reduced hospitalizations
3. Improved quality of life. 		 At baseline and three months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   02/04/2025 
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="3"
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  

Cardiac failure, or heart failure, is a chronic condition that impairs the heart’s ability to pump blood effectively, leading to significant health challenges. Traditional management methods often fall short in areas such as symptom tracking, medication adherence, and patient education. This research project aims to address these shortcomings by developing a novel mobile application for integrated cardiac failure assessment and management. The application will provide real-time, personalized support and monitoring to improve patient outcomes and enhance healthcare delivery. The need for this research is underscored by the potential to reduce hospitalizations and healthcare costs while offering a comprehensive tool that combines symptom monitoring, medication management, education, and secure communication with healthcare providers. This study will also generate valuable insights into the application’s usability and effectiveness, contributing to advancements in mobile health technology for chronic disease management. 

 
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