NCT02084992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

5.3 years

First QC Date

March 10, 2014

Last Update Submit

October 16, 2019

Conditions

Congestive Heart FailureDiastolic Heart FailureSystolic Heart Failure

Keywords

Congestive Heart FailureDisease managementHospitalization

Outcome Measures

Primary Outcomes (1)

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

    90 days

Secondary Outcomes (6)

  • All Cause Mortality

    90 days

  • Cardiovascular Mortality

    90 days

  • Number of days hospitalized for cardiovascular causes at 90 days

    90 days

  • Number of days hospitalized for any cause

    90 days

  • Change in health status as assessed by the SF-12

    90 days

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: Telephonic disease management

Interventions

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.

Expanded technology disease management
Telephonic disease managementOTHER
telephonic disease management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MetroWest Medical Center

Framingham, Massachusetts, 01702, United States

Location

Related Publications (1)

  • 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.

    PMID: 36842486DERIVED

MeSH Terms

Conditions

Heart FailureHeart Failure, DiastolicHeart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Marvin A Konstam, MD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 12, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

October 17, 2019

Record last verified: 2019-10

Locations

US(2)