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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Decompensation Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Hypertension Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Narayana Hrudayalaya Hospital, Bangalore, Karnataka, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Measuring resiliency and reliability of mobile technology for transmitting and retrieval of daily patient vital signs and symptoms as per discharge guideline

Time frame: 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 outcomes

Measuring quality of life score of heart failure patients on a qualitative scale

Time frame: 3 Months

Sponsors and collaborators

Lead sponsor

Aventyn, Inc.

Industry

Collaborators

AT&T
BMS Hospital Trust
University of California
Zephyr Technology

Registry information

Official study title

Remote Monitoring of Heart Failure Patients (REMOTE-HF-1) Study - to Assess Utility of a Mobile Device for Improved Management of At-risk Patients

Acronym: REMOTE-HF-1

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Sep 9, 2011
Registry last updated: Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed