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Trial record 82 of 243823 for:    Diseases

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

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. Identifier: NCT02084992
Recruitment Status : Active, not recruiting
First Posted : March 12, 2014
Last Update Posted : June 3, 2019
Metro West Medical Center
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
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 tablet 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 or disease Intervention/treatment Phase
Congestive Heart Failure Diastolic Heart Failure Systolic Heart Failure Other: Expanded technology disease management Other: Telephonic disease management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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 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, 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

Primary Outcome Measures :
  1. Number of days hospitalized for heart failure per patient-year of follow-up [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 90 days ]
  2. Cardiovascular Mortality [ Time Frame: 90 days ]
  3. Number of days hospitalized for cardiovascular causes at 90 days [ Time Frame: 90 days ]
  4. Number of days hospitalized for any cause [ Time Frame: 90 days ]
  5. Change in health status as assessed by the SF-12 [ Time Frame: 90 days ]
  6. Change in self-care as assessed by the SCHFI [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02084992

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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
MetroWest Medical Center
Framingham, Massachusetts, United States, 01702
Sponsors and Collaborators
Tufts Medical Center
Metro West Medical Center
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Principal Investigator: Marvin A Konstam, MD Tufts Medical Center

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Responsible Party: Tufts Medical Center Identifier: NCT02084992     History of Changes
Other Study ID Numbers: Verizon2014
11111 ( Other Grant/Funding Number: Verizon Foundation )
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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

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