CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
educational interventional groupother
Likely dose
Not stated in record
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Search/NCT03488979
NCT03488979N/ACompleted

Effect of Providing Education and Patient's Inferior Vena Cava Ultrasound Images on Adherence to a Heart Failure Regimen

Johns Hopkins University·observational·Posted Apr 5, 2018·Updated Apr 5, 2018

In Brief

An observational study evaluating educational interventional group for Acute Decompensated Heart Failure. Completed, enrolled 100 participants.

Detailed Summary

Heart failure is a common, costly, and disabling condition characterized by recurrent exacerbations. Episodes of acute decompensated heart failure (ADHF) account for the largest proportion of admissions and 30-day readmissions to US hospitals. Medication nonadherence and dietary/fluid nonadherence have been associated with re-admissions. Hand-carried ultrasound (HCU) devices are portable, relatively inexpensive, and can augment the physical exam in the assessment of volume status. Dilated Inferior Vena Cava (IVC) with poor collapsibility correlates with elevated central venous pressure, which may be correlated with earlier readmission for ADHF. Study design to measure maximum IVC diameter (IVC max) in mm and the degree of IVC collapsibility with inspiration on qualitative assessment in approximately 100 patients admitted with ADHF. The co-investigator will share the IVC images and interpretation with educational intervention group patients in real time; IVC images and interpretation will not be shared with control group patients. Study team will assess whether sharing these IVC measurements correlates with greater adherence to heart failure self-management after discharge, as measured by the administration of the Medical Outcomes Study Specific Adherence Scale, modified to a 3-item version relevant for patients with heart failure (MOSSAS-3HF) at 4 weeks after discharge. Study team will also assess for any difference in 30-day readmission rates for intervention vs. control group patients.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 5, 2018
Enrollment StartMar 16, 2015
Primary CompletionAug 31, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.2 years ago

Interventions

educational interventional groupother

• Patient Education Tool (Appendix 3) and the patient's own IVC images will be shared with each patient in the intervention group in real time. If feasible, each intervention patient will also receive a printed copy of his or her IVC image.