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

NCT02527759 | Completed

• 1 other identifier: 2015-0336
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Survey BEHAVIORAL

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (2)

Medstar, Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Medstar, Georgetown University Hospital

Washington D.C., District of Columbia, 20057, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: August 19, 2015
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 30, 2017
• Last Updated: October 20, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)