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CTRI Number  CTRI/2025/03/082162 [Registered on: 11/03/2025] Trial Registered Prospectively
Last Modified On: 07/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Post-discharge follow up]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Mobile App to Help DCLD patient monitoring Their Health, Medications, Recovery, and Quality of Life 
Scientific Title of Study   Integrated mobile health management system in patient with Decompensated liver disease for monitoring disease progression , Drug compliance , Rehabilitation and quality of life improvement through mobile application  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A G Vimal Kumar 
Designation  Post graduate 
Affiliation  Saveetha Medical College and Hospital 
Address  Department of General Medicine, Third floor in hospital building, Saveetha Medical College and Hospital, Chennai, Tamil Nadu, India - 602105

Chennai
TAMIL NADU
602105
India 
Phone  9786511180  
Fax    
Email  vimalsaibaba@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ram Kumar 
Designation  Professor 
Affiliation  Saveetha Medical College and Hospital 
Address  Department of General Medicine, Third floor in hospital building, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai - 602105, Tamil Nadu, India.

Chennai
TAMIL NADU
602105
India 
Phone  9976416171  
Fax    
Email  docramk444@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ram Kumar 
Designation  Professor 
Affiliation  Saveetha Medical College and Hospital 
Address  Department of General Medicine, Third floor in Hospital building, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai - 602105, Tamil Nadu, India.

Chennai
TAMIL NADU
602105
India 
Phone  9976416171  
Fax    
Email  docramk444@gmail.com  
 
Source of Monetary or Material Support  
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai - 602105, Tamil Nadu, India.  
 
Primary Sponsor  
Name  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF GENERAL MEDICINE SAVEETHA MEDICAL COLLEGE AND HOSPITAL SAVEETHA NAGAR ,THANDALAM CHENNAI BENGALURU ,NH 48 , CHENNAI , TAMILNADU - 602105 , INDIA  
Type of Sponsor  Research institution and hospital 
 
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 
A G Vimal Kumar  Saveetha Medical College and Hospital  Department of General Medicine, Third floor in hospital building, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai - 602105, Tamil Nadu, India.
Chennai
TAMIL NADU 
9786511180

vimalsaibaba@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: R188||Other ascites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional follow-up Arm  Patients in this arm will receive conventional management for Decompensated Liver Disease, which includes periodic clinic visits for disease assessment. 
Intervention  Mobile application users Arm  Patients in this arm will receive the Integrated Mobile Health Management System, a mobile application designed specifically for patients with Decompensated Liver Disease (DCLD). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Confirmed diagnosis of decompensated liver disease
2. Adults aged 18-75 years.
3. Possession and ability to use a compatible smartphone or tablet.
4. Willingness to provide informed consent and comply with study protocols.
5. Clinically stable condition as assessed by a healthcare provider.
6. Understanding of either English or Tamil. 
 
ExclusionCriteria 
Details  1. Severe cognitive impairment or psychiatric disorders preventing effective app usage.
2. Lack of access to a compatible smartphone or tablet.
3. Inability to read or understand English or Tamil, without a reliable bystander to assist.
4. Clinically unstable patients without a reliable bystander to assist with app usage.
5. History of non-compliance with medical treatment or follow-up appointments.
6. Age outside the range of 18-75 years. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Better symptom management and alert tracking.
Slowed disease progression.
Reduced complications and readmissions.
Improved survival and quality of life. 
Period for analysing the data : 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Enhanced drug compliance.
Effective end-of-life care and palliation. 
app follow up till death 
 
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)   18/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="9"
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 Integrated Mobile Health Management System (IMHMS) is a revolutionary solution
tailored for patients with Decompensated Liver Disease (DCLD). DCLD signifies an
advanced stage of liver disease characterized by substantial liver function impairment and the
onset of severe complications stemming from various causes such as chronic viral hepatitis,
alcohol-related liver disease, and genetic liver disorders.
Traditional management methods relying on periodic clinic visits and subjective assessments
often lead to delayed interventions and suboptimal patient care. Moreover, patients with DLD
encounter challenges in adhering to complex treatment regimens and lifestyle modifications,
further exacerbating their condition. To tackle these hurdles head-on, the IMHMS has been
meticulously developed.
The IMHMS harnesses the power of mobile application technology to enable real-time
data collection, analysis, and communication between patients and healthcare professionals.
This innovative approach facilitates comprehensive monitoring of disease progression, drug
adherence,rehabilitation, and overall quality of life, with the overarching goal of optimizing
patient outcomes and averting complications associated with DLD.

Key features of the IMHMS include:
1. Real-time Monitoring: Patients can seamlessly track their symptoms, medication
adherence, and relevant health metrics in real-time, allowing for early detection of changes in
their condition and prompt intervention when necessary.
2.Predictive Analysis Of DCLD Progression :
Prediction of future liver function based on patient - recorded DCLD alert symptoms
1. Sudden Increase in Abdominal Pain
2. Jaundice
3. Swelling or Fluid Retention
4. Confusion or Altered Mental Status
5. Vomiting Blood
6. Significant Weight Gain
7. Severe Fatigue
8. Difficulty Breathing
9. Persistent Fever
10. Signs of Hepatic Encephalopathy and improper drug compliance ,substance abuse and
investigations include blood tests to assess liver function, imaging studies such as ultrasound,
CT scan and UGI scopy , colonoscopy, and liver biopsy procedures for definitive diagnosis
and staging.Personalised risk assessment for complications like hepatic failure, hepatorenal
failure, hepato-pulmonary failure

2. Enhanced Patient Engagement: Through app-based monitoring, patients are empowered to
actively participate in their care, leading to improved adherence to treatment regimens and
lifestyle modifications.
3. Improved Communication: The IMHMS fosters enhanced communication and
collaboration between patients and healthcare providers, facilitating a more patient-centric
and collaborative approach to care delivery.
4. Personalized Care: Healthcare providers can access patient-generated data to tailor
treatment plans and interventions according to individual patient needs, ensuring a more
personalized and effective approach to care.
5. Efficient Data Collection and Analysis: Streamlined data collection and analysis processes
enable more informed decision-making and personalized care delivery, ultimately leading to
better patient outcomes.
6. Remote Monitoring: Remote monitoring capabilities reduce the need for frequent in-person
clinic visits, particularly benefiting patients facing geographical or logistical barriers to
accessing healthcare services.
By empowering patients to actively monitor and manage their DLD, the IMHMS holds the
potential to significantly improve overall quality of life, reduce symptom burden, and
enhance psychological well-being. In addition to monitoring disease progression and
medication adherence, the IMHMS also provides invaluable dietary advice and lifestyle
guidance crucial for effective DCLD management.

Patients are encouraged to follow a balanced diet, limit alcohol intake, maintain a healthy
weight,monitor sodium and protein intake, manage medications carefully, engage in regular
physical activity, and promptly seek medical advice in case of changes or worsening of
symptoms.Through these comprehensive measures, the IMHMS aims to revolutionize DCLD
management and pave the way for improved patient outcomes and enhanced quality of life.
 
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