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

Heart Failure Clinical Trial

— AWARE-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02673073
• Other study ID #: AWARE-HF
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 1, 2016
• Last updated: October 12, 2016
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2016
• Source: Seoul National University Bundang Hospital
• Contact: Dong Ju Choi, MD, PhD
• Phone: 82-31-787
• Email: djchoi[@]snuhb.org
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1220
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Piña IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombo — View 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. — View 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. — View Citation

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després 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, — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	all-cause death		1 year	No
Secondary	cardiovascular death		1 year	No
Secondary	admission for acute heart failure		1 year	No
Secondary	drug compliance		1 year	No