Psychometric Evaluation of the Traditional Chinese Multidimensional Fatigue Inventory in Patients With Heart Failure

NCT07886580 | Not Yet Recruiting FDA Drug FDA Device

• 1 other identifier: KMUHIRB-E(I)-20260259
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

General fatigue is a multidimensional symptom involving physical, cognitive, emotional, and motivational aspects, and it is closely associated with reduced daily functioning and quality of life. In patients with heart failure, fatigue is particularly complex and may persist despite rest. The Multidimensional Fatigue Inventory (MFI) assesses five dimensions of fatigue and has demonstrated good reliability and validity in its Taiwan Traditional Chinese version (MFI-TC) among healthy adults. However, its psychometric properties and clinical usefulness in patients with heart failure have not yet been systematically evaluated.

Conditions

Heart Failure; Fatigue Severity Scale

Keywords

Heart failure; Multidimensional Fatigue Inventory

Outcome Measures

Primary Outcomes (1)

• Multidimensional Fatigue Inventory

  The MFI-TC is a 20-item self-report questionnaire assessing fatigue across five subscales: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity (4 items per subscale). Each item is rated on a 5-point Likert scale (1-5). Subscale scores range from 4 to 20 and the total score ranges from 20 to 100, with higher scores indicating greater fatigue. MFI-TC scores will be used to evaluate psychometric properties in patients with heart failure, including test-retest reliability (intraclass correlation coefficient, ICC), construct validity (confirmatory factor analysis), and convergent validity (correlations with the SF-8a, WHOQOL-BREF, PSQI, and Barthel Index).

  Inpatients: at baseline (prior to hospital discharge) and 1 day after baseline (test-retest). outpatients: at baseline and 1 week after baseline (test-retest).

Secondary Outcomes (4)

• World Health Organization Quality of Life-BREF, Taiwan Version (WHOQOL-BREF)

  Assessed once at baseline (Day 1): prior to hospital discharge for inpatients, and at the first assessment for community-dwelling patients.

• PROMIS Fatigue Short Form 8a (SF-8a)

  Assessed once at baseline (Day 1): prior to hospital discharge for inpatients, and at the first assessment for community-dwelling patients.

• Pittsburgh Sleep Quality Index (PSQI)

  Assessed once at baseline (Day 1): prior to hospital discharge for inpatients, and at the first assessment for community-dwelling patients.

• Barthel Index (BI)

  Assessed once at baseline (Day 1): prior to hospital discharge for inpatients, and at the first assessment for community-dwelling patients.

Study Arms (1)

inhospital and outpatient department

inpatient and outpatient

Other: Questionnaire investigate

Interventions

Questionnaire investigate OTHER

investigate patient with heart failure fatigue codition

inhospital and outpatient department

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population of this study consists of hospitalized patients with heart failure admitted to general wards and community-dwelling patients with heart failure who are aged 20 years or older. Fatigue is a common and clinically significant symptom among patients with heart failure and is closely associated with functional status, exercise tolerance, activities of daily living, and health-related quality of life. Therefore, this study will recruit patients with heart failure who have adequate cognitive function, are able to read and understand Chinese questionnaires, and are willing to participate in the study. The study aims to evaluate the reliability, validity, and clinical applicability of the Taiwan Traditional Chinese version of the Multidimensional Fatigue Inventory (MFI-TC) in this population.

You may qualify if:

• \*\*Hospitalized patients with heart failure:\*\*
• Aged 20 years or older.
• Diagnosed with heart failure by a physician and admitted to a general ward.
• Normal cognitive function, defined as a Mini-Mental State Examination (MMSE) score of ≥24, or meeting the education-adjusted cutoff criteria.
• Able to read Chinese and understand the questionnaire content.
• Willing to participate in the study and provide written informed consent.
• \*\*Community-dwelling patients with heart failure:\*\*
• Aged 20 years or older.
• Diagnosed with heart failure.
• Normal cognitive function, defined as a Mini-Mental State Examination (MMSE) score of ≥24, or meeting the education-adjusted cutoff criteria.
• Able to read Chinese and understand the questionnaire content.
• Willing to participate in the study and provide written informed consent.

You may not qualify if:

• Hospitalized patients with heart failure:
• Presence of other major neurological or psychiatric disorders, such as dementia or severe depression.
• Clinical deterioration requiring transfer to an intensive care unit. Terminal-stage cancer.
• Community-dwelling patients with heart failure:
• Presence of other major neurological or psychiatric disorders, such as dementia or severe depression.
• A history of acute heart failure exacerbation within the past month, or hospitalization due to other medical conditions during the same period.
• Terminal-stage cancer.

Sponsors & Collaborators

• Kaohsiung Medical University: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

TZUYUAN CHIU

CONTACT

+8860968709877; ziyuan.chiumax@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physical therapist

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share