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

October 12, 2016 updated by: Dong-Ju Choi, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1220

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 463707
        • Recruiting
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control_Education
All patients will receive patient's information/education booklet on the heart failure including life style modification.
Other: Patient's education
All patients will receive patient's information/education booklet on the heart failure including life style modification.
Experimental: Intervention_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.
Other: Patient's diary

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Jin Joo Park, MD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWARE-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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