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OpenTrials
Completed

NCT Number: NCT02084992

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients age ≥ 18 with a primary care provider or specialist that is participating within the Collaborative Health ACO.
  • Patient able to consent
  • 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

  • Acute myocardial infarction, PCI or CABG within 30 days before enrollment
  • Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
  • Illness other than heart failure deemed the principal limitation to life expectancy or principal cause of disability
  • Severe angina as the principal cause of limitation
  • 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.
  • Moderate to severe dementia such that unable to participate in disease management program
  • Severe visual or auditory disability such that unable to participate in disease management program
  • Hospice care
  • Listed for heart transplantation
  • No access to a working telephone
  • Homeless or no stable home environment
  • Not speaking a language in which the educational documents have been translated

Treatment and study plan

Expanded technology disease management

Other

Tablet computers loaded with a web-based disease management program will be given to patients for the duration of the study.

Telephonic disease management

Other

Primary outcomes

  1. Number of days hospitalized for heart failure per patient-year of follow-up

    Time frame: 90 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • Metro West Medical Center

Registry information

Official study 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

Acronym: SpanCHFIII

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2014
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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