- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07253506
Turkish Adaptation, Validity, and Reliability Study of the Patient Experience With Treatment and Self-Management Scale in Stroke
Turkish Adaptation, Validity, and Reliability Study of the Patient Experience With Treatment and Self-Management Scale in Stroke Patients
This study will include individuals aged 18-80 years who have been clinically diagnosed with stroke and have spent at least one month at home after discharge. Sociodemographic and clinical characteristics will be recorded. Functional status will be assessed using the Modified Rankin Scale, Brunnstrom Stages, and the Modified Barthel Index. Ambulation status will be documented with the Holden Scale.
The scale will first be translated into Turkish and then back-translated into English by a bilingual expert whose native language is English. The Turkish version of the scale will be administered to patients. Two independent evaluators will apply the scale twice, one week apart.
Validity will be examined by analyzing the relationship between the scale and the Stroke Impact Scale and the Treatment Burden Questionnaire
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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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:
- Clinical diagnosis of stroke (ischemic or hemorrhagic).
- Having spent at least 1 month at home after hospital discharge (to capture post-acute home care/rehabilitation burden).
- Community-dwelling individuals aged 18-80 years.
- Adequate Turkish reading-writing and communication ability.
- Ability to provide informed consent.
- In cases of mild aphasia, ability to complete the questionnaire independently or with support.
Exclusion Criteria:
- History of subarachnoid hemorrhage.
- Inability to communicate effectively due to severe aphasia or severe cognitive impairment.
- Terminal illness (life expectancy < 6 months).
- Inability to complete the questionnaire reliably due to a psychiatric disorder.
- Acute phase (those hospitalized or before discharge).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PETS-Stroke scale
Time Frame: Baseline
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The primary measure, the PETS-Stroke scale, evaluates patients' experiences with treatment and self-management; its scoring system is based on subscale scores typically transformed to 0-100, with higher values reflecting greater perceived burden or difficulty in treatment and self-management.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Modified Rankin Scale
Time Frame: Baseline
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The Modified Rankin Scale will be used to assess overall functional status; this scale measures global disability on a 0-6 range, with higher scores indicating greater dependence.
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Baseline
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Modified Barthel Index
Time Frame: Baseline
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Independence in activities of daily living will be assessed with the Modified Barthel Index, scored between 0 and 100, where higher scores reflect greater functional independence.
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Baseline
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Stroke Impact Scale
Time Frame: Baseline
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To assess construct validity, the Stroke Impact Scale will be used; it measures the impact of stroke on domains such as daily activities, mobility, hand function, communication, emotion, memory, and participation, with domain scores transformed to a 0-100 scale in which higher scores represent better status.
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Baseline
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Treatment Burden Questionnaire
Time Frame: Baseline
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Treatment burden will be evaluated with the Treatment Burden Questionnaire, where items are scored from 0 to 10, and higher scores indicate greater perceived treatment burden.
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Baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- istftrrr
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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