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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07253506
Enrollment
170
Registered
2025-11-28
Start date
2025-11-20
Completion date
2026-04-10
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

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

Interventions

OTHERno intervention

no intervention

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
PETS-Stroke scaleBaselineThe 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.

Secondary

MeasureTime frameDescription
The Modified Rankin ScaleBaselineThe 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.
Modified Barthel IndexBaselineIndependence 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.
Stroke Impact ScaleBaselineTo 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.
Treatment Burden QuestionnaireBaselineTreatment 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026