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

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey (Türkiye)
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Clinical diagnosis of stroke (ischemic or hemorrhagic).

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PETS-Stroke scale
Time Frame: Baseline
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Modified Rankin Scale
Time Frame: Baseline
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.
Baseline
Modified Barthel Index
Time Frame: Baseline
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.
Baseline
Stroke Impact Scale
Time Frame: Baseline
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.
Baseline
Treatment Burden Questionnaire
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this 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 (Estimated)

November 20, 2025

Primary Completion (Estimated)

April 10, 2026

Study Completion (Estimated)

April 10, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

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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