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

Seoul National University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Heart Failure

Treatments: Other: Patient's diary; Other: Patient's education

Study type: Interventional

Funder types: Other

Identifiers

NCT02673073

AWARE-HF

Details and patient eligibility

About

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.

Enrollment: 1,220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,220 participants in 2 patient groups, including a placebo group

Control_Education

Placebo Comparator group

Description:

All patients will receive patient's information/education booklet on the heart failure including life style modification.

Treatment:

Other: Patient's education

Intervention_Diary

Experimental group

Description:

All patients will receive patient's information/education booklet on the heart failure including life style modification. In addition, patients also receive a patient's diary for self-recording of 6 parameters: body weight, blood pressure, heart rate, number of remaining pills, degree of pitting edema, and degree of dyspnea.

Treatment:

Other: Patient's diary