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

Cardiac Decompensation Clinical Trial

— REMOTE-HF-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430936
• Other study ID #: AVN-111
• Status: Completed
• Phase: N/A
• First received: August 12, 2011
• Last updated: July 9, 2012
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2012
• Source: Aventyn, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Decompensation
• Heart Failure

Locations

Country	Name	City	State
India	Narayana Hrudayalaya Hospital	Bangalore	Karnataka
India	Vivus-BMJ Heart Centre	Bangalore	Karnataka
Sweden	Karolinska University Hospital	Stockholm
United States	Winthrop University Hospital	Mineola	New York
United States	Saint Francis Hospital	Roslyn	New York

Sponsors (5)

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

Countries where clinical trial is conducted

United States,  India,  Sweden, 

References & Publications (1)

Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. Epub 2005 Sep 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring resiliency and reliability of mobile technology for transmitting and retrieval of daily patient vital signs and symptoms as per discharge guideline	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.	3 months	No
Secondary	Measuring quality of life score of heart failure patients on a qualitative scale		3 Months	No