Portable Ultrasound to Predict Heart Failure Readmission Risk
Primary Purpose
Heart Failure, Patient Readmission
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring Ultrasound
Eligibility Criteria
Inclusion Criteria: Primary admission diagnosis is listed as congestive heart failure, with an acute component of decompensation. Age greater than 18 years. Principal residence within the geographic reach of our MIH program. Exclusion Criteria: pregnant women
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound
Arm Description
Ultrasound at hospital discharge and at follow up in 7-10 days
Outcomes
Primary Outcome Measures
Hospital Readmission
Hospital readmission within 30 days of discharge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05980533
Brief Title
Portable Ultrasound to Predict Heart Failure Readmission Risk
Official Title
Utility and Feasibility of Prehospital Portable Ultrasound to Predict Heart Failure Readmission Risk
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Guthrie Clinic
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
The purpose of this research is to use a handheld ultrasound to assess patients with congestive heart failure (CHF) to see if the ultrasound can help predict readmission to the hospital. The study will include patients who are admitted to the hospital for CHF. Participants will have two ultrasounds at hospital discharge and at a follow up visit.
Detailed Description
The purpose of this research is to see if a portable ultrasound can help predict readmission to the hospital for patients who are admitted to the hospital for CHF. The study will enroll patients who take part in Mobile Integrated Healthcare as part of their routine care. Participants will have two ultrasounds. The first ultrasound will be at hospital discharge.
Between seven to ten days after hospital discharge participants will be visited at their home in follow-up as the usual standard of care for Mobile Integrated Healthcare. At this visit participants will have a second ultrasound. Participants will be followed for one year for hospital readmission.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Patient Readmission
Keywords
Ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
Ultrasound at hospital discharge and at follow up in 7-10 days
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound at hospital discharge and at follow up at 7-10 days
Primary Outcome Measure Information:
Title
Hospital Readmission
Description
Hospital readmission within 30 days of discharge
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary admission diagnosis is listed as congestive heart failure, with an acute component of decompensation.
Age greater than 18 years.
Principal residence within the geographic reach of our MIH program.
Exclusion Criteria:
pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zachary Dewar, MD
Phone
570-887-4882
Email
Zachary.Dewar@guthrie.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary Dewar
Organizational Affiliation
The Guthrie Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Portable Ultrasound to Predict Heart Failure Readmission Risk
We'll reach out to this number within 24 hrs