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

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02673073
• Collaborator: (none)
• Enrollment: 1,220
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 26

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Patient's diary; Other: Patient's education	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated 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: Jan 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Composite of all-cause death or rehospitalization [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 [1 year]

2. cardiovascular death [1 year]

3. admission for acute heart failure [1 year]

4. drug compliance [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of	463707

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Dong-Ju Choi, MD, PhD, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT02673073
• Other Study ID Numbers: AWARE-HF
• First Posted: Feb 3, 2016
• Last Update Posted: Oct 13, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Dong-Ju Choi, MD, PhD, Seoul National University Bundang Hospital: Heart failure; patient's diary; self awareness
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Oct 13, 2016