Tele-HF: Yale Heart Failure Telemonitoring Study

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00303212
First received: March 13, 2006
Last updated: September 16, 2010
Last verified: September 2010

March 13, 2006
September 16, 2010
March 2006
January 2010   (final data collection date for primary outcome measure)
Rate of all-cause hospital readmission or death during the 6-month follow-up period. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Rate of all-cause hospital readmission or death during the 6-month follow-up period.
Complete list of historical versions of study NCT00303212 on ClinicalTrials.gov Archive Site
  • Rate of all-cause hospital readmissions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of office visits with clinician receiving information from the telemonitoring system [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Survival after index hospitalization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cost of inpatient medical care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Health status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient satisfaction with care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patients' self-management of heart failure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Post index discharge hospital days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Post index discharge hospital days/follow up days alive [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • rate of all-cause hospital readmissions
  • number of office visits with clinician receiving information from the telemonitoring system
  • Survival after index hospitalization
  • cost of inpatient medical care
  • health status
  • patient satisfaction with care
  • patients' self-management of heart failure
Not Provided
Not Provided
 
Tele-HF: Yale Heart Failure Telemonitoring Study
A Study of Telemonitoring to Improve Heart Failure Outcomes

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Congestive Heart Failure
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.
Other Name: Tel-Assurance
  • No Intervention: UC
    Usual HF guideline-base care
  • Experimental: TM
    Telemonitoring group plus usual guideline-based HF care
    Intervention: Other: Telemonitoring

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1660
July 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00303212
RO1-HL-080228, 27466
Yes
Harlan Krumholz. MD, Yale School of Medicine
Yale University
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Harlan M. Krumholz, M.D. Yale University
Study Director: Sarwat I Chaudhry, MD Yale University
Study Director: Jennifer Mattera, MPH Yale University
Yale University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP