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Heart FailurePhase 2/3AWARE-HFNCT02673073

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

A Phase 2/3 study testing Patient's diary and Patient's education in people with Heart Failure, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Patient's diary and Patient's education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,220 participants
Where
1 siteSouth Korea
Study dates
Jan 2016to Dec 2019
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Dong Ju Choi, MD, PhD contact

82-31-787 ext. 7007

djchoi@snuhb.org

Jin Joo Park, MD contact

82-31-787 ext. 7074

jinjooparkmd@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 463707

    Dong-Ju Choi, MD, PhD, 82-31-787-7007, djchoi@snubh.org

    Jin Joo Park, MD, 82-31-787 ext. 7074, jinjooparkmd@gmail.com

    Recruiting

Other trials in South Korea

About this study

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

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.

Conditions
Heart Failure
Being tested
Patient's diary, Patient's education
Keywords
Heart failure, patient's diary, self awareness
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Patient's educationOther

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

Study groups in NCT02673073
Study groupRoleWhat they receive
Control_EducationPlacebo comparatorAll patients will receive patient's information/education booklet on the heart failure including life style modification.
Receives: Other: Patient's education
Intervention_DiaryExperimentalAll 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.
Receives: Other: Patient's diary

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (4)

  1. all-cause death

    Measured: 1 year

  2. cardiovascular death

    Measured: 1 year

  3. admission for acute heart failure

    Measured: 1 year

  4. drug compliance

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02673073
Sponsor's protocol ID
AWARE-HF
Acronym
AWARE-HF
Status last verified
Oct 2016
First submitted
1 Feb 2016
Last updated
13 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 23386663

  • 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.

    PubMed 24054342

  • 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.

    PubMed 24309448

  • 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.

    PubMed 25520374

  • 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.

    PubMed 23616602

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Patient's diary and Patient's education in people with Heart Failure, run by Seoul National University Bundang Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dong Ju Choi, MD, PhD (82-31-787 ext. 7007, djchoi@snuhb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of all-cause death or rehospitalization (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02673073, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.

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