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Clinical Trials/NCT02673073
NCT02673073
Unknown
Phase 2

Self-Awareness of Symptoms, Signs and Medical Compliance Using a Patient Diary in Heart Failure Management (AWARE-HF)

Seoul National University Bundang Hospital1 site in 1 country1,220 target enrollmentJanuary 2016
ConditionsHeart Failure

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Seoul National University Bundang Hospital
Enrollment
1220
Locations
1
Primary Endpoint
Composite of all-cause death or rehospitalization
Last Updated
9 years ago

Overview

Brief Summary

Before a HF patient gets maximally decompensated and visit emergency department, most patients experience symptoms and signs of "on-going decompensation (or pre-decompensation)", which may not be noticed by the patients. If HF patients were aware of symptoms and signs of ADHF and received early intervention to stop the process of "on-going decompensation (or pre-decompensation)", it would be possible to reduce the rate of hospitalization for ADHF or death. Thus, self-awareness and self-examination of heart failure symptoms, signs and medical compliance using a patient diary in HF management may improve the outcomes in chronic stable HF patients. A patient diary with 6 parameters can serve this purpose: body weight, blood pressure, heart rate, drug compliance expressed as number of remaining pills of previous day, edema grade, and dyspnea grade.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
December 2019
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dong-Ju Choi

MD, PhD

Seoul National University Bundang Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients who are 18 years or older
  • Patients admitted for acute heart failure and scheduled for discharge after medical stabilization
  • Chronic stable heart failure patients with a history of hospitalization for AHF

Exclusion Criteria

  • Patients with limited cognitive function who cannot not perform self-recording (in case that the patient has a family member who can perform the recording, the patient can be rerolled)

Outcomes

Primary Outcomes

Composite of all-cause death or rehospitalization

Time Frame: 1 year

Data on primary and secondary measures will be collected a trained study coordinator, using a standardized case report form.

Secondary Outcomes

  • admission for acute heart failure(1 year)
  • cardiovascular death(1 year)
  • all-cause death(1 year)
  • drug compliance(1 year)

Study Sites (1)

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