- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06543121
Validation And Turkish Cross-Cultural Adaptation of Stroke Knowledge Test
Study Overview
Status
Conditions
Detailed Description
Cerebrovascular diseases are the group of diseases that cause the most disability and loss of work, affect the quality of life the most and are the third leading cause of death in the world, and also have a significant place in hospital admissions and expenses. This rate increases with the aging population and comorbidities. The recognition of stroke symptoms by the society is the most important factor in patients reaching treatment opportunities without wasting time.
It is known that failure to provide accurate information to hypertensive patients, who are the highest risk group for stroke, or the patient's failure to understand stroke is associated with a higher risk of stroke and complications. These findings indicate that it is important to provide information to the public about how they behave when they encounter symptoms related to stroke and related conditions. Measuring stroke knowledge and risk factors in hypertensive and potential stroke patients can serve as a healthcare provider who informs the society to adopt stroke prevention behaviors.
Therefore, a valid and reliable assessment tool is of great importance in determining whether hypertensive patients have sufficient knowledge about stroke and improving the long-term clinical outcomes of stroke.
This research aims to perform the cross-cultural adaptation of the Stroke Knowledge Test into Turkish and to examine the validity and reliability of the assessment tool in hypertensive patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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İstanbul, Turkey
- İstanbul BilgiUniversity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Native Turkish and literate
- Diagnosed with hypertension / history of ischemic or hemorrhagic stroke and
- Patients who signed the voluntary consent form will be included.
Exclusion Criteria:
- Participants who are illiterate and
- Participants who have mental problems that may prevent them from answering the test will not be included in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Stroke patients
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The first step is the translation from the original language to the other language.
The ideal target in the translation phase is to use people who are familiar with the structure of the original language and who are familiar with the language.
Two forward translation and one reverse translation methods will be applied after obtaining the written permission of the authors.
After the completion of this phase, the terminological differences arising from the translators in the translation process from the original language to Turkish will be collected and discussed on the questions.
The cultural adaptation study will be terminated by determining the equivalence between the Turkish version of the test and the English original.
The final version of the questionnaire and the necessary changes will be arranged specific to the investigator's society and the authors of the original questionnaire will be consulted and the questionnaire will be finalized.
Content validity will be calculated with the Content Validity Index, which is a result of 10 expert opinions in terms of clarity, difficulty, and suitability of the Turkish version of the Stroke Knowledge Test.
For face validity, the final version of the form will be provided with opinions from 3 stroke patients.
The internal consistency of the items will be tested with Cronbach alpha.
Test-retest reliability will be tested with intraclass correlation coefficient.
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Hypertension patients
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The first step is the translation from the original language to the other language.
The ideal target in the translation phase is to use people who are familiar with the structure of the original language and who are familiar with the language.
Two forward translation and one reverse translation methods will be applied after obtaining the written permission of the authors.
After the completion of this phase, the terminological differences arising from the translators in the translation process from the original language to Turkish will be collected and discussed on the questions.
The cultural adaptation study will be terminated by determining the equivalence between the Turkish version of the test and the English original.
The final version of the questionnaire and the necessary changes will be arranged specific to the investigator's society and the authors of the original questionnaire will be consulted and the questionnaire will be finalized.
Content validity will be calculated with the Content Validity Index, which is a result of 10 expert opinions in terms of clarity, difficulty, and suitability of the Turkish version of the Stroke Knowledge Test.
For face validity, the final version of the form will be provided with opinions from 3 stroke patients.
The internal consistency of the items will be tested with Cronbach alpha.
Test-retest reliability will be tested with intraclass correlation coefficient.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Stroke Knowledge Test
Time Frame: T0 and T1 (Baseline and after 1 week after)
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It consists of 20 questions.
Each question has a single correct answer from one of the 5 options, "I don't know"; this increases the validity of the questionnaire by preventing the participant from guessing the correct answer.
One point is given for each correct answer, no points are given for wrong or "I don't know" answers.
The scores of the 20 questions are added up and a higher score indicates a higher stroke knowledge.
The content of the original scale was selected based on a review of the literature as well as the clinical experience of the original authors regarding factors determined to be important for the education of stroke patients.
The items in the original scale cover the signs, symptoms and risk factors of stroke as well as factors related to the prevention, prevalence, treatment and recovery of stroke.
The internal consistency α value of the original SKT is 0.65 and the test-retest reliability r value is 0.82.
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T0 and T1 (Baseline and after 1 week after)
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Nottingham Health Profile
Time Frame: Baseline
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Divergent validity will be assessed with the Nottingham Health Profile.
It is a general health status measurement that measures patients' quality of life in physical, emotional and social areas.
The Nottingham Health Profile consists of a total of 38 items, including physical mobility (8 items), pain (8 items), sleep (5 items), emotional reactions (9 items), social isolation (5 items) and energy level (3 items).
Each item is answered as "yes" or "no".
A score of 0 is given for a "no" answer and a score of 1 is given for a "yes" answer.
The sum of the positive answers in each section is divided by the total number of statements in that section and the result is multiplied by 100 to obtain possible results between 0 and 100.
A score close to 100 indicates a low quality of life.The internal consistency α value of the measurement tool is 0.87 and the test-retest reliability r value is 0.88.
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mine Gulden Polat, Prof, Marmara University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulBUFC6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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