NCT02673073

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,220

participants targeted

Target at P75+ for phase_2 heart-failure

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

February 1, 2016

Last Update Submit

October 12, 2016

Conditions

Heart Failure

Keywords

Heart failurepatient's diaryself awareness

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • all-cause death

    1 year

  • cardiovascular death

    1 year

  • admission for acute heart failure

    1 year

  • drug compliance

    1 year

Study Arms (2)

Control_Education

PLACEBO COMPARATOR

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

Other: Patient's education

Intervention_Diary

EXPERIMENTAL

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

Interventions

Patient's diaryOTHER

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_Diary
Patient's educationOTHER

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

Control_Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463707, South Korea

RECRUITING

Related Publications (5)

  • 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.

    PMID: 23386663BACKGROUND

  • 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.

    PMID: 24054342BACKGROUND

  • 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.

    PMID: 24309448BACKGROUND

  • 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.

    PMID: 25520374RESULT

  • 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.

    PMID: 23616602RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jin Joo Park, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Ju Choi, MD, PhD

CONTACT

82-31-787djchoi@snuhb.org

Jin Joo Park, MD

CONTACT

82-31-787jinjooparkmd@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 3, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

October 13, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)