Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices

Completed

• Conditions: Cardiac Decompensation

• Registration Number: NCT01430936
• Lead Sponsor: Aventyn, Inc.

Brief Summary

This is planned as a feasibility study. The objective is to evaluate a specially designed patient adherence and monitoring software on standard mobile devices in remote monitoring of heart failure patients.

Detailed Description

Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. The management of heart failure patients is complex and has become a priority world over. Effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system.

Heart failure patients should be in a position to provide readings of their weight, blood pressure, fluid intake, medications and other important parameters and communicate this data to care providers using wireless technology. This data should be made available to medical personnel regularly and on a periodic basis. In this manner the health care providers can detect and respond to warning signs or alerts before the patient's condition worsens to warrant a visit to the doctor or a hospital admission with features of heart failure decompensation.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-09-07
• Study First Posted: 2011-09-09
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Subjects of either gender above the age of 18 years
• The subject is able and willing to provide written informed consent prior to enrollment in the study
• New York Heart Association (NYHA) classification class of II-IV
• Left ventricular ejection fraction (LVEF) less than 40%
• One or more prior hospitalization within the last six months for symptoms, management of heart failure.

Exclusion Criteria

• Disability of fingers or upper limbs (unable to use devices)
• Visually impaired
• Those unable to read and write
• Hearing dysfunction
• Significant cognitive disabilities, mental illness
• Those who are unable to handle electronic devices
• Those residing in places outside the local mobile phone coverage
• Chronic renal failure on renal replacement therapy
• Patients who may not come for follow up or likely to drop out of the study
• Those awaiting cardiac transplantation
• Any illness which may preclude regular follow up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measuring resiliency and reliability of mobile technology for transmitting and retrieval of daily patient vital signs and symptoms as per discharge guideline	3 months	Investigators instruct patients to send the clinical data (all measured parameters plus symptoms experienced over the previous 24 hours) via the mobile device every day to the local investigator. The monitoring site maintains a log of all data transmitted and received from the patient and to the patient and, any device malfunction/technical problems, unscheduled SMS/Text messages from patient and to the patient is also to be documented in the case report form for the entire duration of study.

Secondary Outcome Measures

Name	Time	Method
Measuring quality of life score of heart failure patients on a qualitative scale	3 Months

Trial Locations

Locations (5)

Narayana Hrudayalaya Hospital; 🇮🇳 Bangalore, Karnataka, India

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Vivus-BMJ Heart Centre; 🇮🇳 Bangalore, Karnataka, India

Saint Francis Hospital; 🇺🇸 Roslyn, New York, United States