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

Completed

• Conditions: Heart Failure

• Registration Number: NCT02527759
• Lead Sponsor: Georgetown University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-19
• Study Start: 2016-01
• Status Verified: 2016-12
• Primary Completion: 2017-08
• Study Completion: 2017-08-30
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events of rehospitalization and/or mortality.	30 days	Trial a novel 30-day post-discharge monitoring instrument after hospitalization for heart to evaluate patient status based on patient self-monitoring.

Trial Locations

Locations (2)

Medstar, Washington Hospital Center; 🇺🇸 Washington, D.C., District of Columbia, United States

Medstar, Georgetown University Hospital; 🇺🇸 Washington, D.C., District of Columbia, United States