| Registry | NCT07886580 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 400 (Estimated) |
| Sponsor | Kaohsiung Medical University (Other) |
| Conditions | Heart Failure, Fatigue Severity Scale |
| Interventions | Questionnaire investigate (Other) |
| Dates | start 2026-10-31 (estimated), primary completion 2028-07-31 (estimated), completion 2028-07-31 (estimated), first posted 2026-10-21, last updated 2026-10-21 |
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All trials for Heart Failure All trials for Fatigue Severity Scale All trials of Questionnaire investigate
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| inhospital and outpatient department | Other: Questionnaire investigate | inpatient and outpatient |
Sex: All, ages: 20 Years to any
Inclusion Criteria: * \### Inclusion Criteria **Hospitalized patients with heart failure:** 1. Aged 20 years or older. 2. Diagnosed with heart failure by a physician and admitted to a general ward. 3. Normal cognitive function, defined as a Mini-Mental State Examination (MMSE) score of ≥24, or meeting the education-adjusted cutoff criteria. 4. Able to read Chinese and understand the questionnaire content. 5. Willing to participate in the study and provide written informed consent. **Community-dwelling patients with heart failure:** 1. Aged 20 years or older. 2. Diagnosed with heart failure. 3. Normal cognitive function, defined as a Mini-Mental State Examination (MMSE) score of ≥24, or meeting the education-adjusted cutoff criteria. 4. Able to read Chinese and understand the questionnaire content. 5. Willing to participate in the study and provide written informed consent. Exclusion Criteria: * 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.