Back to resultsA Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure (SpanCHFIII)
Primary Purpose
Congestive Heart Failure, Diastolic Heart Failure, Systolic Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expanded technology disease management
Telephonic disease management
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, Disease management, Hospitalization
Eligibility Criteria
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
Sites / Locations
- Tufts Medical Center
- MetroWest Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Expanded technology disease management
telephonic disease management
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of days hospitalized for heart failure per patient-year of follow-up
Secondary Outcome Measures
All Cause Mortality
Cardiovascular Mortality
Number of days hospitalized for cardiovascular causes at 90 days
Number of days hospitalized for any cause
Change in health status as assessed by the SF-12
Change in self-care as assessed by the SCHFI
Full Information
NCT ID
NCT02084992
First Posted
March 10, 2014
Last Updated
October 16, 2019
Sponsor
Tufts Medical Center
Collaborators
Metro West Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02084992
Brief Title
A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure
Acronym
SpanCHFIII
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 Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Metro West Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Diastolic Heart Failure, Systolic Heart Failure
Keywords
Congestive Heart Failure, Disease management, Hospitalization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Expanded technology disease management
Arm Type
Experimental
Arm Description
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.
Arm Title
telephonic disease management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Expanded technology disease management
Intervention Description
Tablet computers loaded with a web-based disease management program will be given to patients for the duration of the study.
Intervention Type
Other
Intervention Name(s)
Telephonic disease management
Primary Outcome Measure Information:
Title
Number of days hospitalized for heart failure per patient-year of follow-up
Time Frame
90 days
Secondary Outcome Measure Information:
Title
All Cause Mortality
Time Frame
90 days
Title
Cardiovascular Mortality
Time Frame
90 days
Title
Number of days hospitalized for cardiovascular causes at 90 days
Time Frame
90 days
Title
Number of days hospitalized for any cause
Time Frame
90 days
Title
Change in health status as assessed by the SF-12
Time Frame
90 days
Title
Change in self-care as assessed by the SCHFI
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marvin A Konstam, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
MetroWest Medical Center
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure
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