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Clinical Trials/NCT02527759
NCT02527759
Completed
Not Applicable

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

Georgetown University2 sites in 1 country56 target enrollmentJanuary 2016
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Georgetown University
Enrollment
56
Locations
2
Primary Endpoint
Number of participants with adverse events of rehospitalization and/or mortality.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
August 30, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • \> 65 years of age
  • male and female patients admitted to the hospital with the primary diagnosis of HF with hospitalization \> 24 hours
  • able to read and write in English
  • discharged to home environment

Exclusion Criteria

  • a cardiac transplant candidate
  • experienced an acute coronary event within the previous 30 days of index hospitalization
  • experienced percutaneous coronary intervention or coronary artery bypass grafting within the previous 30 days of index hospitalization
  • end stage renal disease/hemodialysis
  • have a left ventricular assist device
  • unable to stand for 90 seconds independently

Outcomes

Primary Outcomes

Number of participants with adverse events of rehospitalization and/or mortality.

Time Frame: 30 days

Trial a novel 30-day post-discharge monitoring instrument after hospitalization for heart to evaluate patient status based on patient self-monitoring.

Study Sites (2)

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