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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Patient's diary
* Other: Patient's education


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control_Education<br>All patients will receive patient's information/education booklet on the heart failure including life style modification. | Other: Patient's education<br>* All patients will receive patient's information/education booklet on the heart failure including life style modification.<br>|
| Experimental: Intervention_Diary<br>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. | Other: Patient's diary<br>* Patients in the intervention arm will be educated to measure body weight, blood pressure, and heart rate every morning after using toilet. Number of remaining pills of the previous day is for the assessment of drug compliance. Degree of pitting edema is graded from 0 (no edema), 1 (mild), 2 (moderate), 3 (severe) and, degree of dyspnea is graded from 0, 1, 2, 3, corresponding to NYHA class I, II, III, and IV, respectively. Patients are instructed to visit or call the HF-outpatient clinic, when they have (i) body weight gain more than 1 kg/day or 2kg in 7 days;(ii) aggravation of pitting edema by one degree; (iii) aggravation of dyspnea by one grade.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause death |  | 1 year | 
| cardiovascular death |  | 1 year | 
| admission for acute heart failure |  | 1 year | 
| drug compliance |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, patient's diary, self awareness