FatigueNCT02596139
Reliability and Validity of the Taiwan-version of Multidimensional Fatigue Inventory and Fatigue Severity Scale
An observational study of Fatigue and Taiwan-version Questionnaire, run by Chang Gung University at 1 site in Taiwan.
Trial summary
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Taiwan-version Questionnaire
- How many people
- 123 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2015to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy people
Who may be able to join
- No cognition or mental disorders
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.
Fatigue Severity Scale (FSS) contains nine statements that rate the severity of fatigue symptoms. The purposes of this study are to translate fatigue questionnaires of -MFI- and -FSS- to Taiwan-version, and to examine the reliability and validity of the scales.
Read more
A hundred adult people without diagnosed physical nor mental disabilities will be recruited. Subjects will fill out the Taiwan-version of MFI, FSS, SF-36 and Pittsburg Sleep Quality Index (PSQI) to establish the validity. Subjects will re-fill the MFI and FSS one week later to evaluate the test-retest reliability.
Another twenty people who are familiar with both English and Chinese will be recruited to evaluate the translation reliability. Subjects will fill out the English version of MFI and FSS and, then, fill out the Taiwan-version of the MFI and FSS with at least ten minutes apart. The translation reliability will be evaluated by paired t test and the intraclass correlation coefficient.
- Conditions
- Fatigue, Taiwan-version Questionnaire
- Being tested
- No Interventions
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy people | Not described Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the reliability and validity of Taiwan-version Multidimensional Fatigue Inventory questionnaire
Measured: 1 week
Assessing the reliability and validity of Taiwan-version Fatigue Severity Scale questionnaire
Measured: 1 week
Secondary outcomes (2)
SF-36 questionnaire
To establish the criterion validity
Measured: Baseline
Pittsburg Sleep Quality Index questionnaire
To establish the criterion validity
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596139
- Sponsor's protocol ID
- 104-0704B
- Status last verified
- Nov 2015
- First submitted
- 2 Nov 2015
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Taiwan-version of Multidimensional Fatigue Inventory and Fatigue Severity Scale
- ClinicalTrials.gov ID
- NCT02596139
- Acronym / sponsor ID
- 104-0704B
- Conditions
- Fatigue, Taiwan-version Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Nov 2015 (estimated)
- 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.
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.
Fatigue Severity Scale (FSS) contains nine statements that rate the severity of fatigue symptoms. The purposes of this study are to translate fatigue questionnaires of -MFI- and -FSS- to Taiwan-version, and to examine the reliability and validity of the scales.
A hundred adult people without diagnosed physical nor mental disabilities will be recruited. Subjects will fill out the Taiwan-version of MFI, FSS, SF-36 and Pittsburg Sleep Quality Index (PSQI) to establish the validity. Subjects will re-fill the MFI and FSS one week later to evaluate the test-retest reliability.
Another twenty people who are familiar with both English and Chinese will be recruited to evaluate the translation reliability. Subjects will fill out the English version of MFI and FSS and, then, fill out the Taiwan-version of the MFI and FSS with at least ten minutes apart. The translation reliability will be evaluated by paired t test and the intraclass correlation coefficient.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy people | – | Other: No Interventions |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy people
Key inclusion criteria (1 listed)
- No cognition or mental disorders
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No Interventions | Other | Healthy people |
Primary outcome
Assessing the reliability and validity of Taiwan-version Multidimensional Fatigue Inventory questionnaire
Time frame: 1 week
Assessing the reliability and validity of Taiwan-version Fatigue Severity Scale questionnaire
Time frame: 1 week
2 secondary outcomes
SF-36 questionnaire
Time frame: Baseline
Pittsburg Sleep Quality Index questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Taiwan-version Questionnaire, run by Chang Gung University at 1 site in Taiwan.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the reliability and validity of Taiwan-version Multidimensional Fatigue Inventory questionnaire (time frame: 1 week). The study lists 2 primary outcomes in all. 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 4 Nov 2015.