REMOTE-HF-1: Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices

Sponsor

Aventyn, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01430936

Collaborator

AT&T (Other), BMS Hospital Trust (Other), University of California (Other), Zephyr Technology (Other)

Enrollment

Locations

Duration (Months)

10.2

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Decompensation

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 Design

Study Type:

Observational

Actual Enrollment :

51 participants

Time Perspective:

Prospective

Official 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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Outcome Measures

Primary Outcome Measures

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

Measuring quality of life score of heart failure patients on a qualitative scale [3 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Winthrop University Hospital	Mineola	New York	United States	11501
2	Saint Francis Hospital	Roslyn	New York	United States	11576
3	Narayana Hrudayalaya Hospital	Bangalore	Karnataka	India	560 099
4	Vivus-BMJ Heart Centre	Bangalore	Karnataka	India	560080
5	Karolinska University Hospital	Stockholm		Sweden	171 77

Sponsors and Collaborators

Aventyn, Inc.
AT&T
BMS Hospital Trust
University of California
Zephyr Technology

Investigators

Principal Investigator: Satish C Govind, MD, PhD, Vivus-BMJ Heart Centre
Principal Investigator: Marcus Stahlberg, MD, PhD, Karolinska University Hospital
Study Director: Bagirath K, MD, Narayana Hruduyalaya Hospital
Study Director: Justine S Lachmann, MD, Winthrop University Hospital
Study Director: Nicole Orr, MD, Saint Francis Memorial Hospital