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

Phase 2

• Conditions: Heart Failure
• Interventions: Other: Patient's diary; Other: Patient's education

• Registration Number: NCT02673073
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1220

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention_Diary	Patient's diary	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.
Control_Education	Patient's education	All patients will receive patient's information/education booklet on the heart failure including life style modification.

Primary Outcome Measures

Name	Time	Method
Composite of all-cause death or rehospitalization	1 year	Data on primary and secondary measures will be collected a trained study coordinator, using a standardized case report form.

Secondary Outcome Measures

Name	Time	Method
admission for acute heart failure	1 year
cardiovascular death	1 year
drug compliance	1 year
all-cause death	1 year

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of