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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
> 400 lbs
unable to stand for 90 seconds independently

Treatment and study plan

survey

Behavioral

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.

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Aug 19, 2015
Registry last updated: Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed