StrokeNCT06543121
Validation And Turkish Cross-Cultural Adaptation of Stroke Knowledge Test
An observational study of Stroke and Hypertension, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
Cerebrovascular diseases are the leading cause of disability, work loss, and quality of life reduction, the third leading cause of death globally, and significantly impact hospital admissions and expenses. This prevalence rises with an aging population and comorbidities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Hypertension
- What is being tested?
- Translating the Stroke Knowledge Test into Turkish and Related Processes, Validity and Internal consistency and Reliability
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 3 Apr 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with stroke or hypertension
Who may be able to join
- Native Turkish and literate
- Diagnosed with hypertension / history of ischemic or hemorrhagic stroke and
- Patients who signed the voluntary consent form will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Cerebrovascular diseases are the leading cause of disability, work loss, and quality of life reduction, the third leading cause of death globally, and significantly impact hospital admissions and expenses. This prevalence rises with an aging population and comorbidities. Recognizing stroke symptoms quickly is crucial for timely treatment. Miscommunication or misunderstanding among hypertensive patients, who are at the highest risk for stroke, increases stroke risk and complications. Educating the public about stroke symptoms and responses is essential for prevention. Therefore, a valid and reliable tool to assess hypertensive patients' stroke knowledge is important for improving long-term outcomes. This research aims to adapt the Stroke Knowledge Test into Turkish and evaluate its validity and reliability in hypertensive patients.
Read the 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.
- Conditions
- Stroke, Hypertension
- Being tested
- Translating the Stroke Knowledge Test into Turkish and Related Processes, Validity, Internal consistency and Reliability
- Keywords
- Stroke Knowledge Test, stroke education, validity, reliability
- Medical subject headings
- Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translating the Stroke Knowledge Test into Turkish and Related ProcessesOther
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.
ValidityOther
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.
Internal consistency and ReliabilityOther
The internal consistency of the items will be tested with Cronbach alpha. Test-retest reliability will be tested with intraclass correlation coefficient.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Not described Receives: Other: Translating the Stroke Knowledge Test into Turkish and Related Processes; Other: Validity; Other: Internal consistency and Reliability | |
| Hypertension patients | Not described Receives: Other: Translating the Stroke Knowledge Test into Turkish and Related Processes; Other: Validity; Other: Internal consistency and Reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Knowledge Test
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.
Measured: T0 and T1 (Baseline and after 1 week after)
Nottingham Health Profile
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Furkan Çakır, Istanbul Bilgi University
- Investigators
- Mine Gulden Polat, Prof, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543121
- Sponsor's protocol ID
- IstanbulBUFC6
- Status last verified
- Apr 2025
- First submitted
- 3 Aug 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation And Turkish Cross-Cultural Adaptation of Stroke Knowledge Test
- ClinicalTrials.gov ID
- NCT06543121
- Acronym / sponsor ID
- IstanbulBUFC6
- Conditions
- Stroke, Hypertension
- Keywords
- Stroke Knowledge Test, stroke education, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 7 Aug 2024 (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.
Cerebrovascular diseases are the leading cause of disability, work loss, and quality of life reduction, the third leading cause of death globally, and significantly impact hospital admissions and expenses. This prevalence rises with an aging population and comorbidities. Recognizing stroke symptoms quickly is crucial for timely treatment. Miscommunication or misunderstanding among hypertensive patients, who are at the highest risk for stroke, increases stroke risk and complications. Educating the public about stroke symptoms and responses is essential for prevention. Therefore, a valid and reliable tool to assess hypertensive patients' stroke knowledge is important for improving long-term outcomes. This research aims to adapt the Stroke Knowledge Test into Turkish and evaluate its validity and reliability in hypertensive patients.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: Translating the Stroke Knowledge Test into Turkish and Related Processes, Other: Validity, Other: Internal consistency and Reliability |
| Hypertension patients | – | Other: Translating the Stroke Knowledge Test into Turkish and Related Processes, Other: Validity, Other: Internal consistency and Reliability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with stroke or hypertension
Key inclusion criteria (3 listed)
- Native Turkish and literate
- Diagnosed with hypertension / history of ischemic or hemorrhagic stroke and
- Patients who signed the voluntary consent form will be included.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Translating the Stroke Knowledge Test into Turkish and Related ProcessesThe 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. | Other | Hypertension patients, Stroke patients |
| ValidityContent 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. | Other | Hypertension patients, Stroke patients |
| Internal consistency and ReliabilityThe internal consistency of the items will be tested with Cronbach alpha. Test-retest reliability will be tested with intraclass correlation coefficient. | Other | Hypertension patients, Stroke patients |
Primary outcome
Stroke Knowledge Test
Time frame: T0 and T1 (Baseline and after 1 week after)
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.
Nottingham Health Profile
Time frame: Baseline
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.
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 29 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Mine Gulden Polat, Prof principal investigator
Marmara University
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 Stroke and Hypertension, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 29 Apr 2025. 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 Turkey (Türkiye). 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?
Stroke Knowledge Test (time frame: T0 and T1 (Baseline and after 1 week after)). 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 29 Apr 2025.