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A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure (Span-CHF III)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Tufts Medical Center
Sponsor:
Collaborators:
New England Quality Care Alliance
Collaborative Health Accountable Care Organization
Metro West Medical Center
St. Vincent’s Hospital.
Robert Bosch Healthcare Systems
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT02084992
First received: March 10, 2014
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

This study will randomize participants with a diagnosis of congestive heart failure and at least one risk factor for hospitalization to either a tablet computer and web based disease management program or a telephone based disease management program. Both interventions are home based with heart failure education and symptom monitoring provided by nurse managers. The nurse managers are in close communication with both the participants and the participants' physicians . The components of the disease management program have been developed at Tufts Medical Center and the New England Quality Care Alliance with studies showing improved clinical outcomes, including reduced hospitalizations. The goal of this study is to transition this successful home monitoring and disease management program to a table computer and web-based implementation to both improve clinical outcomes (reducing hospitalizations and improving self-perceived health status) and improve provider-patient satisfaction. We hypothesize that the tablet computer based disease management will decrease heart failure hospitalizations.


Condition Intervention
Congestive Heart Failure
Diastolic Heart Failure
Systolic Heart Failure
Other: Expanded technology disease management
Other: Telephonic disease management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Controlled Evaluation of Heart Failure Disease Management Using Advanced Telecommunications Within a Diverse Provider Network: The Specialized Primary and Networked Care in HF (SPAN-CHF) III Trial

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Number of days hospitalized for heart failure per patient-year of follow-up [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All Cause Mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Cardiovascular Mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Number of days hospitalized for cardiovascular causes at 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Number of days hospitalized for any cause [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Change in health status as assessed by the SF-12 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Change in self-care as assessed by the SCHFI [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 233
Study Start Date: April 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Expanded technology disease management
After an initial visit where the program is introduced and education regarding adherence, methods for self-monitoring and early reporting of changes in status are reviewed, patients randomized to this arm will be given tablet computers with a web-based heart failure disease management application. Patients will be asked to interact with the system daily with transmission of weight, heart rate, blood pressure and symptom reports to the nurse manager. A nurse manager will check the data daily and contact patients if any parameters exceed pre-specified parameters. Nurse managers will also touch base with the participants at regular intervals as in the control arm. In addition, educational modules will be placed onto individual tablet computers and given to each patient.
Other: Expanded technology disease management
Tablet computers loaded with a web-based disease management program will be given to patients for the duration of the study.
Active Comparator: telephonic disease managemenet
After an initial visit where the program is introduced and education regarding adherence, methods for self-monitoring and early reporting of changes in status are reviewed, the nurse manager will telephone participants weekly for the first month followed by either every two weeks or monthly calls depending on clinical status with the goal of transitioning all participants to monthly calls. During these phone calls the nurse manager will focus on identifying changes in clinical condition and education reinforcement. Participants will be instructed to check and record their weight, heart rate and blood pressure daily and will be encouraged to call if there are any changes in their clinical status.
Other: Telephonic disease management

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients age ≥ 18 with a primary care provider or specialist that is participating within the Collaborative Health ACO.
  2. Patient able to consent
  3. A diagnosis of heart failure with at least one of the following risk factors:

    • Hospitalization for heart failure within the prior year
    • NYHA class III-IV symptoms
    • Most recent BNP ≥ 300 pg/mL (or Nt-proBNP ≥ 600 pg/mL) as long as within 90 days prior to enrollment

Exclusion Criteria:

  1. Acute myocardial infarction, PCI or CABG within 30 days before enrollment
  2. Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
  3. Illness other than heart failure deemed the principal limitation to life expectancy or principal cause of disability
  4. Severe angina as the principal cause of limitation
  5. Uncorrected valvular disease, except where valvular regurgitation was considered to be secondary to severe left ventricular dilation, or where surgical correction is deemed excessively risky or declined by the patient.
  6. Moderate to severe dementia such that unable to participate in disease management program
  7. Severe visual or auditory disability such that unable to participate in disease management program
  8. Hospice care
  9. Listed for heart transplantation
  10. No access to a working telephone
  11. Homeless or no stable home environment
  12. Not speaking a language in which the educational documents have been translated
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02084992

Contacts
Contact: Jenica N Upshaw, MD 617 636 2273 JUpshaw@tuftsmedicalcenter.org

Locations
United States, Massachusetts
MetroWest Medical Center Not yet recruiting
Framingham, Massachusetts, United States, 01702
St. Vincent's Hospital Not yet recruiting
Worcester, Massachusetts, United States, 01608
Sponsors and Collaborators
Tufts Medical Center
New England Quality Care Alliance
Collaborative Health Accountable Care Organization
Metro West Medical Center
St. Vincent’s Hospital.
Robert Bosch Healthcare Systems
Investigators
Principal Investigator: Marvin A Konstam, MD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT02084992     History of Changes
Other Study ID Numbers: Verizon2014, 11111
Study First Received: March 10, 2014
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Congestive Heart Failure
Disease management
Hospitalization

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014