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

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ClinicalTrials.gov Identifier: NCT02673073
Recruitment Status : Unknown
Verified October 2016 by Dong-Ju Choi, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Dong-Ju Choi, 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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Patient's diary Other: Patient's education Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Self-Awareness of Symptoms, Signs and Medical Compliance Using a Patient Diary in Heart Failure Management (AWARE-HF)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. all-cause death [ Time Frame: 1 year ]
  2. cardiovascular death [ Time Frame: 1 year ]
  3. admission for acute heart failure [ Time Frame: 1 year ]
  4. drug compliance [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673073


Contacts
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Contact: Dong Ju Choi, MD, PhD 82-31-787 ext 7007 djchoi@snuhb.org
Contact: Jin Joo Park, MD 82-31-787 ext 7074 jinjooparkmd@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463707
Contact: Dong-Ju Choi, MD, PhD    82-31-787-7007    djchoi@snubh.org   
Contact: Jin Joo Park, MD    82-31-787 ext 7074    jinjooparkmd@gmail.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Jin Joo Park, MD Seoul National University Bundang Hospital
Publications of Results:
Other Publications:
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Responsible Party: Dong-Ju Choi, MD, PhD, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02673073    
Other Study ID Numbers: AWARE-HF
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dong-Ju Choi, Seoul National University Bundang Hospital:
Heart failure
patient's diary
self awareness
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases