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

This study has been completed.
Sponsor:
Collaborators:
AT&T
BMS Hospital Trust
University of California
Zephyr Technology
Information provided by (Responsible Party):
Aventyn, Inc.
ClinicalTrials.gov Identifier:
NCT01430936
First received: August 12, 2011
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Cardiac Decompensation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aventyn, Inc.:

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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Tertiary care population

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430936

Locations
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Saint Francis Hospital
Roslyn, New York, United States, 11576
India
Vivus-BMJ Heart Centre
Bangalore, Karnataka, India, 560080
Narayana Hrudayalaya Hospital
Bangalore, Karnataka, India, 560 099
Sweden
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
  More Information

Publications:
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. No abstract available.

Responsible Party: Aventyn, Inc.
ClinicalTrials.gov Identifier: NCT01430936     History of Changes
Other Study ID Numbers: AVN-111
Study First Received: August 12, 2011
Last Updated: July 9, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Aventyn, Inc.:
Vascular Diseases
Hypertension
Chronic Kidney Disease
COPD

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013