Tele-HF: Yale Heart Failure Telemonitoring Study

Congestive Heart Failure Clinical Trial

Official title:

A Study of Telemonitoring to Improve Heart Failure Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303212
• Other study ID #: 0502027466
• Secondary ID: R01HL080228
• Status: Completed
• Phase: N/A
• Start date: March 2006
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to determine the effectiveness of telemonitoring compared with usual guideline-based care in preventing hospitalization for heart failure patients.

Description:

Heart failure (HF) is a common, costly condition characterized by recurrent periods of clinical decompensation that often lead to repeated hospitalizations (1, 2). Despite advances in the care of patients with HF, population-based outcomes such as mortality and hospitalization rates have not improved substantially over the past decade (3). Episodic, infrequent, outpatient visits are the only usual opportunities for clinicians to detect and treat early signs of HF decompensation; this constitutes a major gap in the current medical model. Moreover, opportunities for patients to take an active role in managing their own conditions occur infrequently. Disease management has emerged as a possible solution to the need for better patient surveillance and engagement. It typically involves multidisciplinary efforts to improve the quality and efficiency of care for patients with chronic conditions, with interventions designed to foster adherence of clinicians to scientific guidelines and patients to treatment plans. However, traditional disease-management programs are generally resource-intensive (often relying on nurse case management), difficult to scale for a large population, and inefficient in providing daily patient monitoring.

Telemonitoring, which bridges clinicians and patients with communication technology, holds promise for closing the gap in HF care (4). This technology has the potential for standardized, widespread implementation (and long-term maintenance) in the near future because it can be easily applied to large patient populations and integrated into the current medical care system. Supporting this potential, preliminary evaluations have suggested that telemonitoring is feasible across a broad spectrum of typical HF patients, relatively inexpensive on a per-patient basis, and highly effective in improving health outcomes. Thus, this approach is ready for rigorous evaluation.

Accordingly, we propose an office-based, multicenter, randomized controlled trial (Tele-HF study) to determine the effectiveness of a telemonitoring strategy in decreasing hospital readmissions and death in patients with HF. Many HF patients experience deterioration in their health status and an increase in weight and symptoms over a period of days and weeks before ultimately presenting to medical attention and requiring hospitalization. Our premise is that a frequent monitoring system can alert clinicians to the early signs and symptoms of decompensation, providing the opportunity for intervention before the patient becomes severely ill and requires hospitalization. Moreover, such a system can engage patients in their care and provide instruction about beneficial self-care strategies. This intervention is not intended to substitute for communication relating to acute care or acute, sudden changes in health status. In these cases, patients are instructed to make direct and immediate contact with their doctor or hospital.

We will use the Pharos Tel-AssuranceTM, an in-home communication system that allows patients to transmit information to their clinicians and provides education to enable patients to actively participate in managing their condition. The system uses conventional telephone lines and does not require the patient to have Internet access. Patients are asked a pre-programmed series of questions and the system automatically uploads the responses to a secure data center. A clinician in each practice can then log on to a secure Internet site using a Web browser to review the patients' responses. The system thus serves as an interface between patients at home and their clinicians, facilitating monitoring of chronic conditions and patient education. While many vendors have potential tools to implement this study, we chose to use Pharos Tel-AssuranceTM because it is simple to use, does not require any equipment in patients' homes and substantial preliminary data suggest high patient and clinician satisfaction with its use. The investigators have no financial interest in this company.

Primary Aim Our primary aim is to determine whether telemonitoring by community-based cardiology office practices reduces the risk of hospital readmission (for any cause) or death after an initial "index hospitalization" for HF. We hypothesize that, among patients recently discharged after a hospitalization for HF, telemonitoring will decrease the rate of rehospitalization or death over 6 months by at least 15% (relative risk reduction). This would yield an absolute risk reduction of 7.5%, so that 1 major adverse event would be averted for every 13 patients.

We have chosen all-cause readmission as part of our primary outcome because poorly controlled HF can result in admissions for a variety of reasons, as the patient becomes weak and susceptible to falls, mental status changes, renal dysfunction, and other debilitating conditions that can result in hospitalization. In addition, from a societal and health system perspective, the overall risk of readmission is more important than disease-specific readmission. Moreover, prior studies suggest that telemonitoring can reduce this outcome.

Secondary Aims

In our secondary aims we will determine whether telemonitoring will:

1. Reduce the rate of all-cause hospital readmission

2. Reduce the rate of hospital readmission for HF

3. Reduce the total number of all-cause and HF-specific hospital readmissions

4. Increase office visits with the clinician receiving information from the telemonitoring system

5. Improve survival after index hospitalization

6. Reduce the cost of inpatient medical care

7. Improve health status

8. Improve patient satisfaction with care

9. Improve patients' self-management of HF

Sub-Group Analyses

The following sub-group analyses will be conducted:

1. Age

2. Sex

3. Race

4. HFPEF vs depressed EF

5. Education

6. Insurance status

7. Self-reported access to care

8. Baseline self-efficacy and self-care

9. Socioeconomic Status

10. Site characteristics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1660
• Est. completion date: July 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 years or older

• hospitalized for heart failure within the past 30 days

• access to telephone line

Exclusion Criteria:

• not expected to survive 6 months due to irreversible, life-threatening condition

• has or scheduled for cardiac transplant or LVAD

• scheduled for CABG or PCI within 90 days

• severe valvular disease

• Folstein MMSE score less than 20

• resident of a nursing home

• currently a prisoner

• does not speak English or Spanish

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Other:
• Telemonitoring
Participants in the intervention group are instructed to make a daily toll-free call to an automated telemonitoring system being provided by Pharos Innovations® (Chicago, IL) for 6 months.On each call patients hear a pre-recorded voice that goes through a series of questions about symptoms and the patient's daily weight. Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians at each practice site.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Morehouse School of Medicine/Cardiology	Atlanta	Georgia
United States	Piedmont Hospital Research Institute	Atlanta	Georgia
United States	Department of Cardiology at Bridgeport Hospital	Bridgeport	Connecticut
United States	Cooper Health System Cardiology	Camden	New Jersey
United States	MetroHealth Medical Center, Heart & Vascular Center	Cleveland	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	The Dayton Heart Center	Dayton	Ohio
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	Chabert Medical Center	Houma	Louisiana
United States	Indiana Heart Physicians	Indianapolis	Indiana
United States	Iowa City Heart Center	Iowa City	Iowa
United States	St. Luke's Hospital / Mid-America Heart Institute	Kansas City	Missouri
United States	Truman Medical Center/Cardiology	Kansas City	Missouri
United States	Heart Clinic of Louisiana	Marrero	Louisiana
United States	Loyola University Medical Center	Maywood	Illinois
United States	Cardiology Associates	Mobile	Alabama
United States	Cardiology Associates of New Haven	New Haven	Connecticut
United States	New York University/Cardiology	New York	New York
United States	Sentara Cardiology Consultants, Ltd.	Norfolk	Virginia
United States	UC Irvine Medical Center	Orange	California
United States	St. Joseph's Regional Medical Center / Cardiology Associates	Paterson	New Jersey
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Cardiology Diagnostics	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	Integrated Care / Cardiovascular Consultants of South Florida	Tamarac	Florida
United States	UCLA Harbor Medical Center	Torrance	California
United States	Cardiology Associates, LLC	Tupelo	Mississippi
United States	Howard University Hospital	Washington	District of Columbia
United States	Cardiology Specialists, Ltd.	Westerly	Rhode Island
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of all-cause hospital readmission or death during the 6-month follow-up period.		6 months
Secondary	Rate of all-cause hospital readmissions		6 months
Secondary	Number of office visits with clinician receiving information from the telemonitoring system		6 months
Secondary	Survival after index hospitalization		6 months
Secondary	Cost of inpatient medical care		6 months
Secondary	Health status		6 months
Secondary	Patient satisfaction with care		6 months
Secondary	Patients' self-management of heart failure		6 months
Secondary	Post index discharge hospital days		6 months
Secondary	Post index discharge hospital days/follow up days alive		6 months