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

NCT01430936 | Completed

• 1 other identifier: AVN-111
• Study Type: observational
• Target: 51
• Locations: 3 countries
• Sites: 5

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.

Conditions

Cardiac Decompensation

Keywords

Vascular Diseases; Hypertension; Chronic Kidney Disease; COPD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  3 Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary care population

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aventyn, Inc.: lead
• AT&T: collaborator
• BMS Hospital Trust: collaborator
• University of California: collaborator
• Zephyr Technology: collaborator

Study Sites (5)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Saint Francis Hospital

Roslyn, New York, 11576, United States

Location

Narayana Hrudayalaya Hospital

Bangalore, Karnataka, 560 099, India

Location

Vivus-BMJ Heart Centre

Bangalore, Karnataka, 560080, India

Location

Karolinska University Hospital

Stockholm, Stockholm County, 171 77, Sweden

Location

Related 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. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.

  PMID: 16160202 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Vascular Diseases; Hypertension; Renal Insufficiency, Chronic; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Satish C Govind, MD, PhD

  Vivus-BMJ Heart Centre

  PRINCIPAL INVESTIGATOR

• Marcus Stahlberg, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Bagirath K, MD

  Narayana Hruduyalaya Hospital

  STUDY DIRECTOR

• Justine S Lachmann, MD

  Winthrop University Hospital

  STUDY DIRECTOR

• Nicole Orr, MD

  Saint Francis Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: September 9, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

SE (1); US (2); IN (2)