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

NCT ID: NCT02084992

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2019-09-01

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.

Conditions

Congestive Heart Failure; Diastolic Heart Failure; Systolic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Expanded technology disease management

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Telephonic disease management

Intervention Type: OTHER

Interventions

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.

Intervention Type: OTHER

Telephonic disease management

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Metro West Medical Center

OTHER

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marvin A Konstam, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

MetroWest Medical Center

Framingham, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36842486 (View on PubMed)

Other Identifiers

11111

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Verizon2014

Identifier Type: -

Identifier Source: org_study_id