An observational study in Heart Failure and Fatigue Severity Scale, sponsored by Kaohsiung Medical University. Not yet recruiting. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Kaohsiung Medical University · Observational
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.
"General fatigue" is widely regarded in both clinical and general population research as a multidimensional symptom experience centered on subjective perception, rather than a phenomenon that can be defined by a single physiological indicator. Multiple review studies have indicated that, regardless of disease type, patients' descriptions of fatigue commonly encompass physical, cognitive, and emotional/motivational dimensions. Therefore, multidimensionality has become a widely accepted characteristic of the fatigue construct. These studies emphasize that fatigue should not be simply reduced to "muscle weakness" or "sleepiness." Rather, it represents a persistent or recurrent sense of energy depletion accompanied by reduced tolerance for activity, and is closely associated with limitations in activities of daily living and health-related quality of life.
In patients with heart failure, fatigue is not merely a feeling of being "tired" or experiencing reduced physical strength. Instead, it is a complex symptom involving physiological, psychological, and behavioral dimensions. It is commonly manifested as persistent or abnormally severe energy depletion, reduced motivation to engage in activities, and restricted participation in physical functioning. Importantly, such fatigue may not be completely relieved even after adequate rest.
The Multidimensional Fatigue Inventory (MFI) is a widely used self-reported instrument for assessing fatigue. It consists of 20 items and evaluates five dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity. These dimensions reflect the multidimensional characteristics of fatigue across perceived energy levels, physical functioning, cognitive burden, and behavioral participation.
In Taiwan, researchers have translated the MFI into Traditional Chinese and evaluated the reliability and validity of the Taiwan Traditional Chinese version of the MFI (MFI-TC) in a general adult population. The study followed a standardized cross-cultural adaptation process. The findings demonstrated that the MFI-TC had good content validity, an appropriate factor structure, and acceptable to excellent Cronbach's alpha coefficients across its subscales. In addition, the MFI-TC showed theoretically meaningful associations with related constructs, including self-perceived health status, sleep, and quality of life, supporting its feasibility and stability for use among generally healthy adults in Taiwan.
Nevertheless, existing studies of the MFI-TC have primarily focused on healthy adult populations. Its psychometric properties and clinical applicability have not yet been systematically evaluated in patients with heart failure, a population characterized by a high burden of fatigue and distinctive pathophysiological mechanisms.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 400 is above the median of 200 across 1,719 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Kaohsiung Medical University is the lead sponsor of 56 studies on the registry; 17 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
**Hospitalized patients with heart failure:**
**Community-dwelling patients with heart failure:**
Exclusion Criteria:
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.
inpatient and outpatient
Other: Questionnaire investigate
investigate patient with heart failure fatigue codition
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).
Time frame: Inpatients: at baseline (prior to hospital discharge) and 1 day after baseline (test-retest). outpatients: at baseline and 1 week after baseline (test-retest).
World Health Organization Quality of Life-BREF, Taiwan Version (WHOQOL-BREF)
The WHOQOL-BREF Taiwan version is a self-report questionnaire developed by the WHOQOL Group and culturally adapted for use in Taiwan to assess quality of life. It consists of 28 items, including the 26 standard items and two Taiwan-specific items. The items cover four domains: Physical Health, Psychological Health, Social Relationships, and Environment, plus two general items on overall quality of life and general health. Each item is rated on a 5-point Likert scale with reference to the past two weeks. Domain scores range from 4 to 20, with higher scores indicating better quality of life. Negatively worded items are reverse-scored. In this study, the WHOQOL-BREF is used to examine the convergent validity of the MFI-TC; higher fatigue is expected to be associated with poorer quality of life.
Time frame: 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)
The PROMIS Fatigue Short Form 8a is a self-report questionnaire developed by the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative to assess fatigue. It consists of 8 items that evaluate the experience of fatigue, such as feelings of tiredness and lack of energy, and its impact on daily activities and physical, mental, and social functioning. Each item is rated on a 5-point Likert scale with reference to the past 7 days. Raw scores range from 8 to 40 and can be converted to standardized T-scores (mean = 50, SD = 10), with higher scores indicating greater fatigue. In this study, the SF-8a is used as a comparison fatigue measure to examine the convergent validity of the MFI-TC; a positive correlation between the two measures is expected.
Time frame: 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)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire developed by Buysse and colleagues to assess sleep quality and disturbances. It consists of 19 self-rated items grouped into seven components: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbances, Use of Sleeping Medication, and Daytime Dysfunction. The questionnaire refers to the past month. Each component is scored from 0 to 3, and the component scores are summed to give a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global score greater than 5 indicates poor sleep. In this study, the PSQI is used to examine the convergent validity of the MFI-TC; poorer sleep quality is expected to be associated with greater fatigue.
Time frame: Assessed once at baseline (Day 1): prior to hospital discharge for inpatients, and at the first assessment for community-dwelling patients.
Barthel Index (BI)
The Barthel Index (BI) is a widely used measure developed by Mahoney and Barthel to assess independence in basic activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers, mobility on level surfaces, and stair climbing. In this study, the BI is administered by a trained research team member through interview. Items are weighted according to the level of assistance required, and the total score ranges from 0 to 100, with higher scores indicating greater independence in daily living. The BI is used to examine the convergent validity of the MFI-TC; greater fatigue is expected to be associated with lower functional independence.
Time frame: Assessed once at baseline (Day 1): prior to hospital discharge for inpatients, and at the first assessment for community-dwelling patients.
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Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Kaohsiung Medical University