NCT06923514

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 18, 2025

Last Update Submit

March 18, 2026

Conditions

Keywords

Machine learning, health literacy, stress, quality of life.

Outcome Measures

Primary Outcomes (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.

    one year

Secondary Outcomes (1)

  • health literacy

    one year

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Hei-Fen Hwang, PhD

    Natinal Taipei University of Nursing and Health Sciencs

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

April 11, 2025

Study Start

November 20, 2024

Primary Completion

November 3, 2025

Study Completion

November 3, 2025

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations