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CompletedNCT02527759Updated Oct 20, 2017

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

An observational study in Heart Failure, sponsored by Georgetown University. Completed at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-10-20.

Sponsored by Georgetown University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
56
Ages
65 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 56 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

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Lead sponsor

Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with heart failure

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
56 participants (actual)
Patient registry
No

Interventions

  • BehavioralSurvey
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What researchers measure

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.

    Time frame: 30 days

07

Study locations

2 sites
  • Medstar, Washington Hospital Center
    Washington, D.C., District of Columbia 20010, United States
  • Medstar, Georgetown University Hospital
    Washington, D.C., District of Columbia 20057, United States
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References and documents

Individual participant data

Plan to share: No — There is no plan to make individual participant data available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02527759
Lead sponsor
Georgetown University
Responsible party
Sponsor
First posted
Aug 19, 2015
Start date
Jan 2016
Primary completion
Aug 2017
Completion
Aug 30, 2017
Last update
Oct 20, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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