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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Patient's diary
Patient's education
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Heart failure, patient's diary, self awareness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control_Education

Intervention_Diary

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

all-cause death
cardiovascular death
admission for acute heart failure
drug compliance

Full Information

First Posted
February 1, 2016
Last Updated
October 12, 2016
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02673073
Brief Title
Self-Awareness of Symptoms, Signs and Medical Compliance Using a Patient Diary in Heart Failure Management
Acronym
AWARE-HF
Official Title
Self-Awareness of Symptoms, Signs and Medical Compliance Using a Patient Diary in Heart Failure Management (AWARE-HF)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, patient's diary, self awareness

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control_Education
Arm Type
Placebo Comparator
Arm Description
All patients will receive patient's information/education booklet on the heart failure including life style modification.
Arm Title
Intervention_Diary
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Patient's diary
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Patient's education
Intervention Description
All patients will receive patient's information/education booklet on the heart failure including life style modification.
Primary Outcome Measure Information:
Title
Composite of all-cause death or rehospitalization
Description
Data on primary and secondary measures will be collected a trained study coordinator, using a standardized case report form.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
all-cause death
Time Frame
1 year
Title
cardiovascular death
Time Frame
1 year
Title
admission for acute heart failure
Time Frame
1 year
Title
drug compliance
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Ju Choi, MD, PhD
Phone
82-31-787
Ext
7007
Email
djchoi@snuhb.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Joo Park, MD
Phone
82-31-787
Ext
7074
Email
jinjooparkmd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Joo Park, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi, MD, PhD
Phone
82-31-787-7007
Email
djchoi@snubh.org
First Name & Middle Initial & Last Name & Degree
Jin Joo Park, MD
Phone
82-31-787
Ext
7074
Email
jinjooparkmd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23386663
Citation
Retrum JH, Boggs J, Hersh A, Wright L, Main DS, Magid DJ, Allen LA. Patient-identified factors related to heart failure readmissions. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):171-7. doi: 10.1161/CIRCOUTCOMES.112.967356. Epub 2013 Feb 5.
Results Reference
background
PubMed Identifier
24054342
Citation
Lee KS, Lennie TA, Warden S, Jacobs-Lawson JM, Moser DK. A comprehensive symptom diary intervention to improve outcomes in patients with HF: a pilot study. J Card Fail. 2013 Sep;19(9):647-54. doi: 10.1016/j.cardfail.2013.07.001.
Results Reference
background
PubMed Identifier
24309448
Citation
Kato N, Kinugawa K, Nakayama E, Tsuji T, Kumagai Y, Imamura T, Maki H, Shiga T, Hatano M, Yao A, Miura C, Komuro I, Nagai R. Insufficient self-care is an independent risk factor for adverse clinical outcomes in Japanese patients with heart failure. Int Heart J. 2013;54(6):382-9. doi: 10.1536/ihj.54.382.
Results Reference
background
PubMed Identifier
25520374
Citation
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available. Erratum In: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.
Results Reference
result
PubMed Identifier
23616602
Citation
Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.
Results Reference
result

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

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