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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02673073
Acronym
AWARE-HF
Enrollment
1220
Registered
2016-02-03
Start date
2016-01-31
Completion date
2019-12-31
Last updated
2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, patient's diary, self awareness

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.

Interventions

OTHERPatient'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.

OTHERPatient's education

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

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Composite of all-cause death or rehospitalization1 yearData on primary and secondary measures will be collected a trained study coordinator, using a standardized case report form.

Secondary

MeasureTime frame
all-cause death1 year
cardiovascular death1 year
admission for acute heart failure1 year
drug compliance1 year

Countries

South Korea

Contacts

Primary ContactDong Ju Choi, MD, PhD
djchoi@snuhb.org82-31-787
Backup ContactJin Joo Park, MD
jinjooparkmd@gmail.com82-31-787

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026