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Use of Telemonitoring System in Heart Failure Patients (I get better)

Primary Purpose

Heart Failure, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
web based telemonitoring system
Conventional
Sponsored by
Danbury Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Danbury Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Telemonitoring

Control

Arm Description

Subjects were assigned to web based telemonitoring system.

Subjects were assigned to conventional monitoring.

Outcomes

Primary Outcome Measures

Rate of hospital readmission for heart failure

Secondary Outcome Measures

Quality of life: questioninaire
Quality of life based on Minnesota Living with Heart Failure Questionnaire, Range 0-105, from best to worst quality of life. First time given at time of enrollment and then 45 days after enrollment, a member of the research team contacted patient by phone to complete the questionnaire.
Perceived effect of the intervention on heart-failure related care
Perceived effect of the intervention on heart-failure related care based on the Perceived effect of telemonitoring questionnaire. 45 days after enrollment, a member of the research team contacted patient by phone to complete the following questions : Felt more in the control of the disease Felt more connected with the medical team Felt that it reminded to take the pills Each question is answered on the following scale: very true, true, somewhat true, and not true at all.

Full Information

First Posted
March 2, 2020
Last Updated
March 3, 2020
Sponsor
Danbury Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04294303
Brief Title
Use of Telemonitoring System in Heart Failure Patients
Acronym
I get better
Official Title
Heart Failure Self-Management Using a Mobile Web-Based Telemonitoring System- Impact on Hospital Readmissions and Quality of Life SELF-e HF
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 3, 2016 (Actual)
Primary Completion Date
April 11, 2018 (Actual)
Study Completion Date
January 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danbury Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
60 patients will be recruited for this study. After signing the consent form, participant will be randomized to receive usual care (i.e. they will get the current standard care for patients with heart failure) or usual care and participation in the iGetBetter program. Participant will complete a questionnaire in the hospital about their quality of life. iGetBetter group will be given a Bluetooth-equipped scale, blood pressure cuff, and a tablet with a data plan. Participant will check their weight and blood pressure at home daily, using the equipment provided. This information will be sent via the internet to iGetBetter's web server, where the data will be temporarily stored. The data will be monitored by the physician researcher. If their blood pressure is high (e.g. greater than or equal to 140/90 for two days in a row) or they gain a significant amount of weight (e.g. 2 pounds in two days), the study team will be automatically notified. A member of the study team will alert participant cardiologist and the cardiologist will have the option to make any recommendations, such as contacting the subject to schedule an office visit. Total participation in this study will last 45 days after patient is discharged from the hospital. Regardless of the assigned group, participant will be asked to complete two questionnaires after 45 days. A member of the research team will contact participant by phone to complete these questionnaires. One of these questionnaires will investigate their quality of life; the other will assess how participant feel the care they have received has affected their health. Patients assigned to the iGetBetter group will also complete a third survey about their satisfaction with the program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemonitoring
Arm Type
Experimental
Arm Description
Subjects were assigned to web based telemonitoring system.
Arm Title
Control
Arm Type
Other
Arm Description
Subjects were assigned to conventional monitoring.
Intervention Type
Other
Intervention Name(s)
web based telemonitoring system
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional
Intervention Description
Subjects in the control group received the standard patient teaching, including an instruction to self-monitor their weight.
Primary Outcome Measure Information:
Title
Rate of hospital readmission for heart failure
Time Frame
45 days after enrollment
Secondary Outcome Measure Information:
Title
Quality of life: questioninaire
Description
Quality of life based on Minnesota Living with Heart Failure Questionnaire, Range 0-105, from best to worst quality of life. First time given at time of enrollment and then 45 days after enrollment, a member of the research team contacted patient by phone to complete the questionnaire.
Time Frame
45 days after enrollment
Title
Perceived effect of the intervention on heart-failure related care
Description
Perceived effect of the intervention on heart-failure related care based on the Perceived effect of telemonitoring questionnaire. 45 days after enrollment, a member of the research team contacted patient by phone to complete the following questions : Felt more in the control of the disease Felt more connected with the medical team Felt that it reminded to take the pills Each question is answered on the following scale: very true, true, somewhat true, and not true at all.
Time Frame
45 days after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age and older Admitted to Danbury Hospital with heart failure NYHA functional class II-IV Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Galin, MD
Organizational Affiliation
Danbury Hospital, Nuvance Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Telemonitoring System in Heart Failure Patients

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