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Heart FailureNCT06923514

Health Literacy, Stress and Quality of Life in Heart Failure Patients

An observational study of Heart Failure, run by Cheng-Hsin General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Heart failure is showing a trend of affecting younger individuals. Middle-aged heart failure patients are often the economic backbone of their families. Studies have also pointed out that approximately 38.5% of patients with acute heart failure are re-hospitalized within a year of discharge due to worsening symptoms. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Heart Failure
How many people
158 participants
Where
1 siteTaiwan
Study dates
20 Nov 2024to 3 Nov 2025
Phase
Observational
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Heart failure patients

Who may be able to join

  • The study subjects are cardiology patients aged 18-65 diagnosed with heart failure classified as NYHA II or above by specialists at a regional teaching hospital in northern Taiwan

Who cannot join

  • 1.severe mental disease.2. terminal stage of other disease such as cancer.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Cheng Hsin General Hospital

    Taipei, 112

Other trials in Taiwan

About this study

Official title: Using Machine Learning to Analyze the Prediction and Correlation of Health Literacy, Stress and Quality of Life in Heart Failure Patients

Heart failure is showing a trend of affecting younger individuals. Middle-aged heart failure patients are often the economic backbone of their families. Studies have also pointed out that approximately 38.5% of patients with acute heart failure are re-hospitalized within a year of discharge due to worsening symptoms. Patients with lower health literacy tend to have poorer health outcomes and higher re-hospitalization rates. However, there is limited research on the life and work stress, health literacy, and quality of life of middle-aged heart failure patients. Therefore, this study aims to use machine learning to analyze and predict the correlations between health literacy, stress, and quality of life in heart failure patients.

This research is a cross-sectional correlational study, adopting convenience sampling. The study subjects are cardiology patients aged 18-65 diagnosed with heart failure classified as NYHA II or above by specialists at a regional teaching hospital in northern Taiwan. Data collection took place in the outpatient and inpatient departments of cardiology and cardiothoracic surgery. Structured questionnaires were used for one-on-one interviews, including basic demographic information of heart failure patients, the Chinese version of the European Health Literacy Survey Questionnaire (HLS-EU-Q47), the Chinese version of the Brief Resilience Scale (BRS), the Perceived Stress Scale (PSS), and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Data will be recorded using Excel, and statistical analysis will be conducted using SPSS version 22. Descriptive statistics such as percentages, means, and standard deviations will be used to describe the demographic and variable distributions. Independent t-tests, ANOVA, and Pearson correlation coefficient will be used to analyze correlations between variables. Machine learning will be employed to analyze and predict quality of life factors in heart failure patients. It is hoped that the results of this study can provide references for nursing practice, help with clinical patient assessment, and improve the quality of care for patients.

Conditions
Heart Failure
Keywords
Machine learning, health literacy, stress, quality of life.
Medical subject headings
Heart Failure

What is being measured

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

  1. Minnesota Living with Heart Failure Questionnaire

    Use the Chinese version of the Minnesota Heart Failure Quality of Life to assess quality of life.

    Use the Chinese version of the Minnesota Heart Failure Quality of Life Questionnaire.There are 21 questions in total, scored from 0 to 5, with a total score of 105. The higher the score, the more serious the impact of the disease on life.

    Measured: one year

Secondary outcomes (1)

  1. health literacy

    Use the Chinese version of European Health Literacy Survey Questionnaire (HLS-EU-Q) to assess health literacy .

    Use the Chinese version of HLS-EU-Q.There are 47 questions in total. Based on a four-point Likert scale, Total score 0-50. 0-25 means Inadequate,26-33 means Problematic,34-42 means Sufficient,43-50 means Excellent.

    Measured: one year

Timeline

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

  1. First posted11 Apr 2025
  2. Study start20 Nov 2024
  3. Primary completion3 Nov 2025
  4. Study completion3 Nov 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06923514
Sponsor's protocol ID
(1133)113A-63
Status last verified
Mar 2026
First submitted
18 Mar 2025
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kuhn TA, Gathright EC, Dolansky MA, Gunstad J, Josephson R, Hughes JW. Health Literacy, Cognitive Function, and Mortality in Patients With Heart Failure. J Cardiovasc Nurs. 2022 Jan-Feb 01;37(1):50-55. doi: 10.1097/JCN.0000000000000855.

    PubMed 34581712

  • Jiang S, Zhang X, Li X, Li Y, Yang W, Yao Y, Fu L, Zhao M, Zang X. Exploring Health Literacy Categories in Patients With Heart Failure: A Latent Class Analysis. J Cardiovasc Nurs. 2023 Jan-Feb 01;38(1):13-22. doi: 10.1097/JCN.0000000000000889. Epub 2022 Jan 13.

    PubMed 36508237

  • Heo S, Kang J, Shin MS, Lim YH, Kim SH, Kim S, An M, Kim J. Physical Symptoms, Depressive Symptoms, and Quality of Life in Patients With Heart Failure: Cluster Analysis. J Cardiovasc Nurs. 2024 Jan-Feb 01;39(1):31-37. doi: 10.1097/JCN.0000000000001043. Epub 2023 Sep 29.

    PubMed 37787730

  • Gowani AAA, Low G, Norris C, Hoben M. Internal structure validity and internal consistency reliability of the Minnesota Living with Heart Failure Questionnaire: a systematic review protocol. BMJ Open. 2023 Nov 8;13(11):e076780. doi: 10.1136/bmjopen-2023-076780.

    PubMed 37940148

  • Cajita MI, Cajita TR, Han HR. Health Literacy and Heart Failure: A Systematic Review. J Cardiovasc Nurs. 2016 Mar-Apr;31(2):121-30. doi: 10.1097/JCN.0000000000000229.

    PubMed 25569150

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Cheng-Hsin General Hospital at 1 site in Taiwan.

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 1 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: finished, as of the sponsor's last update on 19 Mar 2026. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minnesota Living with Heart Failure Questionnaire (time frame: one 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 NCT06923514, 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 19 Mar 2026.

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