Congestive Heart FailureSpanCHFIIINCT02084992
A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure
A study testing Expanded technology disease management and Telephonic disease management in people with Congestive Heart Failure and Diastolic Heart Failure, run by Tufts Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Diastolic Heart Failure, Systolic Heart Failure
- What is being tested?
- Expanded technology disease management and Telephonic disease management
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts Medical Center
Boston, Massachusetts, 02111
MetroWest Medical Center
Framingham, Massachusetts, 01702
About this study
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
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.
- Being tested
- Expanded technology disease management, Telephonic disease management
- Keywords
- Congestive Heart Failure, Disease management, Hospitalization
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded technology disease managementOther
Tablet computers loaded with a web-based disease management program will be given to patients for the duration of the study.
Telephonic disease managementOther
| Study group | Role | What they receive |
|---|---|---|
| Expanded technology disease management | Experimental | 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. Receives: Other: Expanded technology disease management |
| telephonic disease management | Active comparator | 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. Receives: Other: Telephonic disease management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days hospitalized for heart failure per patient-year of follow-up
Measured: 90 days
Secondary outcomes (6)
All Cause Mortality
Measured: 90 days
Cardiovascular Mortality
Measured: 90 days
Number of days hospitalized for cardiovascular causes at 90 days
Measured: 90 days
Number of days hospitalized for any cause
Measured: 90 days
Change in health status as assessed by the SF-12
Measured: 90 days
Change in self-care as assessed by the SCHFI
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startJun 2014
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Metro West Medical Center
- Responsible party
- Sponsor
- Investigators
- Marvin A Konstam, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084992
- Sponsor's protocol ID
- Verizon2014
- Other IDs
- 11111
- Acronym
- SpanCHFIII
- Status last verified
- Oct 2019
- First submitted
- 10 Mar 2014
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Upshaw JN, Parker S, Gregory D, Koethe B, Vest AR, Patel AR, Kiernan MS, DeNofrio D, Davidson E, Mohanty S, Arpin P, Strauss N, Sommer C, Brandon L, Butler R, Dwaah H, Nadeau H, Cantor M, Konstam MA. The effect of tablet computer-based telemonitoring added to an established telephone disease management program on heart failure hospitalizations: The Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) III Randomized Controlled Trial. Am Heart J. 2023 Jun;260:90-99. doi: 10.1016/j.ahj.2023.02.007. Epub 2023 Feb 25.
PubMed 36842486
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02084992
- Acronym / sponsor ID
- SpanCHFIII / Verizon2014
- Keywords
- Congestive Heart Failure, Disease management, Hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Metro West Medical Center
- Study start
- Jun 2014
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expanded technology disease management | Experimental | Other: Expanded technology disease managementAfter 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. |
| telephonic disease management | Active comparator | Other: Telephonic disease managementAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded technology disease managementTablet computers loaded with a web-based disease management program will be given to patients for the duration of the study. | Other | Expanded technology disease management |
| Telephonic disease management | Other | telephonic disease management |
Primary outcome
Number of days hospitalized for heart failure per patient-year of follow-up
Time frame: 90 days
6 secondary outcomes
All Cause Mortality
Time frame: 90 days
Cardiovascular Mortality
Time frame: 90 days
Number of days hospitalized for cardiovascular causes at 90 days
Time frame: 90 days
Number of days hospitalized for any cause
Time frame: 90 days
Change in health status as assessed by the SF-12
Time frame: 90 days
Change in self-care as assessed by the SCHFI
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Derived from this study: PubMed 36842486Upshaw JN, Parker S, Gregory D, Koethe B, Vest AR, Patel AR, Kiernan MS, DeNofrio D, Davidson E, Mohanty S, Arpin P, Strauss N, Sommer C, Brandon L, Butler R, Dwaah H, Nadeau H, Cantor M, Konstam MA. The effect of tablet computer-based telemonitoring added to an established telephone disease management program on heart failure hospitalizations: The Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) III Randomized Controlled Trial. Am Heart J. 2023 Jun;260:90-99. doi: 10.1016/j.ahj.2023.02.007. Epub 2023 Feb 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marvin A Konstam, MD principal investigator
Tufts Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded technology disease management and Telephonic disease management in people with Congestive Heart Failure and Diastolic Heart Failure, run by Tufts Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days hospitalized for heart failure per patient-year of follow-up (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02084992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.