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

NCT ID: NCT02527759

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Survey

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medstar, Washington Hospital Center

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

Site Status

Medstar, Georgetown University Hospital

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

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-0336

Identifier Type: -

Identifier Source: org_study_id