- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03927092
Reliability and Validity of the Turkish Version of the Multiple Sclerosis Knowledge Questionnaire
April 25, 2019 updated by: Ece Cinar, Ege University
Multiple Sclerosis Knowledge Questionnaire (MSKQ) is a 25-item self administered questionnaire assessing a patient's level of knowledge regarding multiple sclerosis (MS).
Turkish translation of the questionnaire was prepared and participants in the annual patient education seminar in the investigators' university hospital were asked to answer these questions before and after the seminar.Their results were analysed to assess their level of knowledge about their disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Multiple sclerosis knowledge questionnaire was developed in Italy (1) and was reported to be useful in measuring patients' level of knowledge about their disease.
The English version of the questionnaire was translated into Turkish by three physicians than back translated into English by two separate linguists.
Initially 5 MS patients were asked to answer this first version of the questionnaire and report any difficulties in understanding the items.
Their feedback was used to give the questionnaire its final shape.
For the validation stage, patients that were diagnosed as having MS and who attended the annual MS patient education seminar were enrolled into the study.
They answered the questions twice, before and after the seminar.
Their answers were analysed to measure their level of knowledge about their disease.
Study Type
Observational
Enrollment (Actual)
58
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed as having multiple sclerosis.
Description
Inclusion Criteria:
- Diagnosed as having Multiple Sclerosis
- Attends the annual patient education seminar at the investigators' university hospital
- Older than 18 years of age
- Can read and write
Exclusion Criteria:
- Does not accept to answer the questionnaire
- Unable to answer the questions due to a cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Multiple Sclerosis patients
Patients that attended an annual patient education seminar at the investigators' university hospital were asked to fill out the Turkish version of the Multiple Sclerosis Knowledge Questionnaire
|
A 25-item self-administered questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reliability of the questionnaire
Time Frame: 1 day
|
Internal consistency was evaluated by the coefficient alpha (α) or Cronbach's coefficient, and if the Cronbach's coefficient value was greater than 0.7, it was considered as an acceptable internal consistency
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of correct answers
Time Frame: 1 day
|
To assess the distribution of correct and false answers and the levels of significance, Chi-square test was used.
To compare the two questionnaires answered by the same patient before and after the seminar Wilcoxon signed-rank test was used.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ece Cinar, M.D., Ege University School of Medicine
- Study Director: Yesim Akkoc, M.D., Ege University School of Medicine
- Principal Investigator: Funda Calis, M.D., Ege University School of Medicine
- Principal Investigator: Musa Baklaci, M.D., Ege University School of Medicine
- Principal Investigator: Ozgul Ekmekci, M.D., Ege University School of Medicine
- Principal Investigator: Ayse N Yuceyar, M.D., Ege University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
April 23, 2019
First Submitted That Met QC Criteria
April 23, 2019
First Posted (Actual)
April 25, 2019
Study Record Updates
Last Update Posted (Actual)
April 29, 2019
Last Update Submitted That Met QC Criteria
April 25, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-4.1/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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