NCT06543121

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

August 3, 2024

Last Update Submit

April 28, 2025

Conditions

Keywords

Stroke Knowledge Teststroke educationvalidityreliability

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline

Study Arms (2)

Stroke patients

Other: Translating the Stroke Knowledge Test into Turkish and Related ProcessesOther: ValidityOther: Internal consistency and Reliability

Hypertension patients

Other: Translating the Stroke Knowledge Test into Turkish and Related ProcessesOther: ValidityOther: Internal consistency and Reliability

Interventions

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.

Hypertension patientsStroke patients

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.

Hypertension patientsStroke patients

The internal consistency of the items will be tested with Cronbach alpha. Test-retest reliability will be tested with intraclass correlation coefficient.

Hypertension patientsStroke patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with stroke or hypertension

You may qualify if:

  • Native Turkish and literate
  • Diagnosed with hypertension / history of ischemic or hemorrhagic stroke and
  • Patients who signed the voluntary consent form will be included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul BilgiUniversity

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeHypertension

Interventions

Reproducibility of Results

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesEvaluation Studies as TopicHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Mine Gulden Polat, Prof

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2024

First Posted

August 7, 2024

Study Start

September 1, 2024

Primary Completion

April 1, 2025

Study Completion

April 3, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Locations