Heart FailureNCT07886580
Psychometric Evaluation of the Traditional Chinese Multidimensional Fatigue Inventory in Patients With Heart Failure
An observational study of Heart Failure and Fatigue Severity Scale, run by Kaohsiung Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Fatigue Severity Scale
- What is being tested?
- Questionnaire investigate
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ### Inclusion Criteria
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
"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.
- Conditions
- Heart Failure, Fatigue Severity Scale
- Being tested
- Questionnaire investigate
- Keywords
- Heart failure, Multidimensional Fatigue Inventory
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire investigateOther
investigate patient with heart failure fatigue codition
| Study group | Role | What they receive |
|---|---|---|
| inpatient and outpatient department | inpatient and outpatient Receives: Other: Questionnaire investigate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed once at baseline (Day 1): prior to hospital discharge for inpatients, and at the first assessment for community-dwelling patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TZUYUAN CHIU, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886580
- Sponsor's protocol ID
- KMUHIRB-E(I)-20260259
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Evaluation of the Traditional Chinese Multidimensional Fatigue Inventory in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07886580
- Acronym / sponsor ID
- KMUHIRB-E(I)-20260259
- Conditions
- Heart Failure, Fatigue Severity Scale
- Keywords
- Heart failure, Multidimensional Fatigue Inventory
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inpatient and outpatient department | – | Other: Questionnaire investigateinpatient and outpatient |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- ### Inclusion Criteria
- 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.
Key exclusion criteria (7 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire investigateinvestigate patient with heart failure fatigue codition | Other | inpatient and outpatient department |
Primary outcome
Multidimensional Fatigue Inventory
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).
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).
4 secondary outcomes
World Health Organization Quality of Life-BREF, Taiwan Version (WHOQOL-BREF)
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)
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)
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)
Time frame: Assessed once at baseline (Day 1): prior to hospital discharge for inpatients, and at the first assessment for community-dwelling patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Fatigue Severity Scale, run by Kaohsiung Medical University.
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 13 inclusion and 7 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: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TZUYUAN CHIU (+8860968709877, ziyuan.chiumax@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Fatigue Inventory (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.