Washington, D.C., District of Columbia 20010

  • Heart Failure

Purpose:

The purpose of this study is to examine the relative predictive ability of the derived monitoring instrument to determine post discharge instability and 30-day outcomes in patients discharged with HF. The primary hypothesis is that variables in the monitoring instrument, individually and combined, identify risk for 30-day outcomes. Clinical indicators of dyspnea, fatigue, orthopnea, dyspnea with exertion, daily weight, edema, heart rate, blood pressure, mental condition, medication adherence, and overall well-being will be reported by participants on a daily basis and considered indicators for 30-day outcomes of stability, re-hospitalization, or mortality.


Criteria:

Inclusion Criteria: 1. > 65 years of age 2. male and female patients admitted to the hospital with the primary diagnosis of HF with hospitalization > 24 hours 3. able to read and write in English 4. discharged to home environment Exclusion Criteria: 1. a cardiac transplant candidate 2. experienced an acute coronary event within the previous 30 days of index hospitalization 3. experienced percutaneous coronary intervention or coronary artery bypass grafting within the previous 30 days of index hospitalization 4. end stage renal disease/hemodialysis 5. have a left ventricular assist device 6. > 400 lbs 7. unable to stand for 90 seconds independently


Study is Available At:


Original ID:

2015-0336


NCT ID:

NCT02527759


Secondary ID:


Study Acronym:


Brief Title:

Patient Self Monitoring to Evaluate 30 Day Post Discharge Heart Failure Outcomes


Official Title:

Patient Self Monitoring to Evaluate 30 Day Post Discharge Heart Failure Outcomes


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

65 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Georgetown University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

56


Enrollment Type:

Actual


Study Dates

Start Date:January 2016
Completion Date:August 30, 2017
Completion Type:Actual
Primary Completion Date:August 2017
Primary Completion Type:Actual
Verification Date:December 2016
Last Changed Date:October 18, 2017
First Received Date:April 14, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of participants with adverse events of rehospitalization and/or mortality.
Time Frame:30 days
Safety Issues:False
Description:Trial a novel 30-day post-discharge monitoring instrument after hospitalization for heart to evaluate patient status based on patient self-monitoring.

Study Interventions

Intervention Type:Behavioral
Name:Survey

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Georgetown University

Samples and Retentions

Study Population: Patients with heart failure
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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