Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices (REMOTE-HF-1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01430936 |
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Recruitment Status :
Completed
First Posted : September 9, 2011
Last Update Posted : July 10, 2012
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| Condition or disease |
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| Cardiac Decompensation |
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 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 : | January 2011 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | April 2012 |
- 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 ]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.
- Measuring quality of life score of heart failure patients on a qualitative scale [ Time Frame: 3 Months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430936
| United States, New York | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| Saint Francis Hospital | |
| Roslyn, New York, United States, 11576 | |
| India | |
| Narayana Hrudayalaya Hospital | |
| Bangalore, Karnataka, India, 560 099 | |
| Vivus-BMJ Heart Centre | |
| Bangalore, Karnataka, India, 560080 | |
| Sweden | |
| Karolinska University Hospital | |
| Stockholm, Sweden, 171 77 | |
| 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 |
| Responsible Party: | Aventyn, Inc. |
| ClinicalTrials.gov Identifier: | NCT01430936 |
| Other Study ID Numbers: |
AVN-111 |
| First Posted: | September 9, 2011 Key Record Dates |
| Last Update Posted: | July 10, 2012 |
| Last Verified: | July 2012 |
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Vascular Diseases Hypertension Chronic Kidney Disease COPD |
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Heart Failure Heart Diseases Cardiovascular Diseases |