Clinical trial NCT01430936: Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Decompensation
Keywords: Vascular Diseases
Hypertension
Chronic Kidney Disease
COPD
Lead sponsor: Aventyn, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AT&T
name: BMS Hospital Trust
name: University of California
name: Zephyr Technology
First posted: 2011-09-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary care population

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.

Eligibility 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

Primary outcomes:
measure: Measuring resiliency and reliability of mobile technology for transmitting and retrieval of daily patient vital signs and symptoms as per discharge guideline
timeFrame: 3 months
Secondary outcomes:
measure: Measuring quality of life score of heart failure patients on a qualitative scale
timeFrame: 3 Months
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Roslyn
country: United States
facility: Saint Francis Hospital
state: New York
city: Bangalore
country: India
facility: Narayana Hrudayalaya Hospital
state: Karnataka
city: Bangalore
country: India
facility: Vivus-BMJ Heart Centre
state: Karnataka
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Vivus-BMJ Heart Centre
name: Satish C Govind, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Marcus Stahlberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Narayana Hruduyalaya Hospital
name: Bagirath K, MD
role: STUDY_DIRECTOR
affiliation: Winthrop University Hospital
name: Justine S Lachmann, MD
role: STUDY_DIRECTOR
affiliation: Saint Francis Hospital
name: Nicole Orr, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.