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