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临床试验/CTRI/2025/03/082162
CTRI/2025/03/082162尚未招募不适用

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

SAVEETHA MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Better symptom management and alert tracking.

研究概览

简要总结

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

  1. 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.

  1. 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.

  1. 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.

  1. 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.

  1. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.Confirmed diagnosis of decompensated liver disease
  • Adults aged 18-75 years.
  • Possession and ability to use a compatible smartphone or tablet.
  • Willingness to provide informed consent and comply with study protocols.
  • Clinically stable condition as assessed by a healthcare provider.
  • Understanding of either English or Tamil.

排除标准

  • Severe cognitive impairment or psychiatric disorders preventing effective app usage.
  • Lack of access to a compatible smartphone or tablet.
  • Inability to read or understand English or Tamil, without a reliable bystander to assist.
  • Clinically unstable patients without a reliable bystander to assist with app usage.
  • History of non-compliance with medical treatment or follow-up appointments.
  • Age outside the range of 18-75 years.

结局指标

主要结局

Better symptom management and alert tracking.

时间窗: Period for analysing the data : 3 months

Slowed disease progression.

时间窗: Period for analysing the data : 3 months

Reduced complications and readmissions.

时间窗: Period for analysing the data : 3 months

Improved survival and quality of life.

时间窗: Period for analysing the data : 3 months

次要结局

  • Enhanced drug compliance.(Effective end-of-life care and palliation.)

研究者

发起方
SAVEETHA MEDICAL COLLEGE AND HOSPITAL
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

A G Vimal Kumar

Saveetha Medical College and Hospital

研究点 (1)

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