Adaptation and Validation of the LUNS for Use in Turkey.

Stroke Clinical Trial

Official title: Adaptation and Validation Study of the Longer- Term Unmet Needs After Stroke Questionnaire Into Turkish

Status Recruiting

Clinical Trial Summary

According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke.

Our hypothesis in this study is:

• The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) is a valid tool for assessing the unmet needs of stroke patients in the Turkish population.

Clinical Trial Description

Stroke is one of the top causes of mortality worldwide, and has decreased in many countries, but an increasing number of stroke survivors are living with a disability after being discharged from the hospital. Approximately 25-30% of stroke patients will remain disabled and they will be largely dependent upon their family members and caregivers for their daily living activities. According to patients' perceptions of whether they have received any or enough assistance with a particular challenge, or of whether an issue has not been addressed at all or properly, unmet needs observed by stroke survivors may be practically evaluated. Also, it is critical to identify unmet requirements of stroke survivors in order to inform the delivery of health and social care services. The available data demonstrates that post-acute and chronic stroke survivors have a wide range of unmet requirements. Based on various contextual factors such as the availability of health and social care services, the number of years after stroke, the degree of disability, and demographic parameters, each stroke survivor has, on average, two to five unmet requirements. The Longer-term Unmet Needs after Stroke (LUNS) monitoring tool, is a 22-item questionnaire developed by The Longer-Term Stroke Care (LoTS care) study team (ref1). This questionnaire concerns the need for information as well as the physical, social, and emotional consequences of stroke. According to a cross-sectional study among 850 British stroke survivors, the lower LUNS scores were consistently related to poorer (mental) health according to the Short Form 12 (SF-12) (ref1). Groeneveld et al. translated and cross-culturally adapted the LUNS into Dutch and assessed its psychometric properties in chronic stroke survivors (ref2). Also, LUNS have been translated into different languages such as Korean, Brazil, and Malawi (ref3-4).

According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke.

Permission has already been received from Bradford Teaching Hospitals NHS Foundation Trust.

This study will include two stages.; The stage will include the translation and adaptaion procedure of the original English version of the LUNS instrument into Turkish (LUNS-T). The second and the final stage will include the reliability and the validity study of the LUNS-T and this step will be performed according to the guidelines of Beaton et al. for the process of cross-cultural adaptation of self-report measures (ref5). Finally, we will assess the reliability and the validity of LUNS-T.

Stage 1. Translation and adaptation of LUNS into Turkish and establishment of Turkish LUNS (T-LUNS).

This stage will include translation, synthesis, back translation, expert committee review, and pretesting of the pre-final version of T-LUNS according to the guidelines for the process of cross-cultural adaptation of self-report measures proposed by Beaton DE et.al, 2000 (ref5).

Stage 2. Reliability and validity study of the T-LUNS. To test the reliability and validity of the T-LUNS, 110 chronic stroke survivors fulfilling the inclusion/exclusion criteria at the 3 study sites will be assessed. The assessment of each patient will include recording of the demographic and clinical characteristics and administration of the T-LUNS as well as the Turkish version of the Stroke Impact Scale 3.0 (SIS). For the assessment of test-retest reliability of the T-LUNS, half of the participants (n= 55) will fill in the T-LUNS again, 2 weeks after the first administration.

Sample size: It is planned to include at least 110 participants in the study with a 5:1 ratio between the sample size and the number of items (ref6).

Statistical analysis:

Mean, standard deviation, median, interquartile range, frequency, and percentage will be used as descriptive statistics. Student's t-test for continuous variables, Mann Whitney U test for ordinal variables, chi-square test, or Fisher's exact chi-square test for categorical variables will be used for comparisons between two independent groups. Cohen's kappa coefficient will be used to analyze the degree of agreement of the test-retest agreement of the scale items.

An exploratory factor analysis (EFA) for categorical data using the weighted least square method will be used to investigate the dimensionality of the item of the questionnaire (T-LUNS). Model fit will be evaluated using the root-mean-square error of approximation (RMSEA) that accounts for model parsimony. RMSEA values <0.08 suggest adequate fit; values <0.05 indicate good fit (ref7). Items with factor loadings below 0.30 will be eliminated. A p-value less than 0.05 will be considered significant. External construct validity of the T-LUNS will be tested by the investigation of the association with the relevant domains of the Stroke Impact Scale. ;

Related Conditions & MeSH terms

• Disability Physical
• Quality of Life
• Stroke

• NCT number: NCT06278805
• Study type: Observational
• Source: Usak University
• Contact: ALI Y KARAHAN, Assoc. Prof
• Phone: +905386921934
• Email: ali.karahan@usak.edu.tr
• Status: Recruiting
• Start date: March 1, 2024
• Completion date: February 1, 2025