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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527759
• Other study ID #: 2015-0336
• Status: Completed
• Phase: N/A
• First received: April 14, 2015
• Last updated: October 18, 2017
• Start date: January 2016
• Est. completion date: August 30, 2017

Study information

• Verified date: December 2016
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 30, 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Survey

Locations

Country	Name	City	State
United States	Medstar, Georgetown University Hospital	Washington, D.C.	District of Columbia
United States	Medstar, Washington Hospital Center	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

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