NCT02596139

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
Last Updated

November 4, 2015

Status Verified

November 1, 2015

Enrollment Period

5 months

First QC Date

November 2, 2015

Last Update Submit

November 2, 2015

Conditions

FatigueTaiwan-version Questionnaire

Outcome Measures

Primary Outcomes (2)

  • Assessing the reliability and validity of Taiwan-version Multidimensional Fatigue Inventory questionnaire

    1 week

  • Assessing the reliability and validity of Taiwan-version Fatigue Severity Scale questionnaire

    1 week

Secondary Outcomes (2)

  • SF-36 questionnaire

    Baseline

  • Pittsburg Sleep Quality Index questionnaire

    Baseline

Study Arms (1)

Healthy people

Other: No Interventions

Interventions

No InterventionsOTHER
Healthy people

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy people

You may qualify if:

  • No cognition or mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 4, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 4, 2015

Record last verified: 2015-11

Locations

TW(1)