NCT04294303

Brief Summary

Heart failure is a major public health problem worldwide. Heart failure is one of the most common causes for hospitalizations among people over 65 years of age in the United States. Nationwide, approximately 25% of patients admitted to a hospital for heart failure are readmitted to a hospital within 30 days.Multiple transitional care interventions, including telemonitoring, aimed to decrease hospital readmission rates and improve quality of life in heart failure (HF) patients have been explored. Most studies evaluated effectiveness of telemonitoring used in conjunction with other interventions. In this study, investigators studied the role of a potentially cost-effective, telemonitoring program in reducing readmissions and improving quality of life among patients admitted with HF exacerbation in a teaching hospital. They aimed to determine impact of a standalone telemonitoring system. Primary outcome: Rate of hospital readmission for heart failure Secondary outcomes: Quality of life, Perceived effect of the intervention on heart-failure related care

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 3, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

March 2, 2020

Last Update Submit

March 3, 2020

Conditions

Heart FailureQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Rate of hospital readmission for heart failure

    45 days after enrollment

Secondary Outcomes (2)

  • Quality of life: questioninaire

    45 days after enrollment

  • Perceived effect of the intervention on heart-failure related care

    45 days after enrollment

Study Arms (2)

Telemonitoring

EXPERIMENTAL

Subjects were assigned to web based telemonitoring system.

Other: web based telemonitoring system

Control

OTHER

Subjects were assigned to conventional monitoring.

Other: Conventional

Interventions

web based telemonitoring systemOTHER

Subjects in the telemonitoring group were given an iPad with installed iHealth application, a scale, and an electronic blood pressure monitor (a mobile web-based telemonitoring system). These devices were interconnected via Bluetooth. The iPad had permanent internet connection. Patients were taught to use the equipment to check and record their weight, blood pressure, and heart rate every morning, for 45 days after the hospital discharge. Data was automatically uploaded via iHealth application in a secure database.

Telemonitoring
ConventionalOTHER

Subjects in the control group received the standard patient teaching, including an instruction to self-monitor their weight.

Control

Eligibility Criteria

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

You may qualify if:

  • years of age and older
  • Admitted to Danbury Hospital with heart failure
  • NYHA functional class II-IV

You may not qualify if:

  • Not agreeable to participate in the study
  • ESRD on HD
  • Severe COPD (O2/steroid dependent?)
  • Pregnancy
  • Hospice patients/bed bound patients
  • Severe valvular disease, or recent valvular intervention (within 1 year) or planned valvular intervention.
  • Expected to be transferred to another acute care hospital
  • Solid organ transplant recipient or listed for transplant, recipient of left ventricular assist device or planned to receive one
  • Homeless participants
  • Active psychiatric disorders, addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Ira Galin, MD

    Danbury Hospital, Nuvance Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of the vascular Medicine Program

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 4, 2020

Study Start

February 3, 2016

Primary Completion

April 11, 2018

Study Completion

January 29, 2020

Last Updated

March 5, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)