- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05313698
Validity and Reliability of The Turkish Version of The Kidscreen-27
31. maj 2022 opdateret af: Hasan Bingöl, Muş Alparlan University
Validity and Reliability of The Turkish Version of The Kidscreen-27 Questionnaires in Individuals With Cerebral Palsy
Functional impairment of the upper extremities can impair the health-related quality of life (HRQOL) of persons with Cerebral Palsy CP.
Health-related quality of life (HRQOL) measures several subjective dimensions dealing with the impact of health or illness on physical and psychosocial functioning.
Quality of life (QOL) measures for children and adolescents have been developed in recent years, initially for children with specific chronic conditions, but more recently generic and health-related QOL (HRQOL) measures have been developed .
The early assessments of children's quality of life were mostly disease-specific, and this trend has continued.
Generic HRQOL measurements for children and adolescents can help identify subgroups of children and adolescents who are at risk of developing health problems.
KIDSCREEN-27 is a generic HRQOL measure derived from KIDSCREEN-52.
The KIDSCREEN-27 is a subset of the KIDSCREEN-52 that includes 27 items for assessing HRQOL across five dimensions: Physical Well-Being (5 items) examines a child's or adolescent's level of physical activity, energy, and fitness.
Although the psychometric properties of the Turkish version of the KIDSCREEN forms have been studied previously; however, its psychometric characteristics in children with CP have yet to be determined.
Accordingly, the aim of this study is to provide an overview of the psychometric results of the KIDSCREEN-27 HRQOL questionnaire
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Children with CP generally report a lower QOL than their normally developing peers.
Quality of life (QOL) is now recognized as an important outcome of interventions because it relates to a person's individual cognition or well-being in a range of domains (e.g., physical, social, emotional, spiritual).
Health-related quality of life (HRQOL) is a subdomain of the more global construct of QOL, including domains such as physical, mental, and social well-being Recently, there has been a surge in interest in assessing the quality of life (QOL) of children with cerebral palsy (CP).
QOL instruments are increasingly used to assess the effectiveness of interventions for children with CP.
To assess QOL, there are both generic and condition-specific scales available.
The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child), the Child Health Questionnaire (CHQ), European generic health related quality of life questionnaire (KIDSCREEN), and the Pediatric Quality of Life Inventory are some of the most used instruments.
Out of these QOL instruments, European generic health related quality of life questionnaire (KIDSCREEN) is a generic QOL questionnaire and KIDSCREEN-27 is a shorter version of the KIDSCREEN-52 questionnaire to evaluate HRQOL outcomes of children and adolescents between the ages of 8-18 years. .
Generic scales are useful for comparing groups since they are designed to be relevant to all subgroups of the population.
Because they do not include domains that are relevant to the sickness or disability, they are less useful for evaluating the effectiveness of an intervention for children with that illness or disability.
Condition-specific scales are useful for detecting changes in QOL for a given condition and are designed to be applicable to a group.
Instruments that are condition-specific can capture the domains of QOL that are significant to children and adolescents with CP.
Although the psychometric properties of KIDSCREEN-27 tests have been extensively studied in healthy children and adolescents, there has been no research to date on the psychometric features of KIDSCREEN-27 instruments in cerebral palsy children and adolescents.
Thus, the aims of this study were to examine and determine the construct-concurrent validity and reliability of the Turkish version of the self and proxy versions of KIDSCREEN-27 questionnaire in individuals with cerebral palsy
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
135
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Ankara, Kalkun, 06100
- Hacettepe University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
8 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Children with all typologies of cerebral palsy and their parents/caregivers
Beskrivelse
Inclusion Criteria:
Children with cerebral palsy who have sufficient intellectual level to answer KIDSCREEN-27' items
Exclusion Criteria:
children with severe intellectual disability
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Consistency from baseline in mean scores of KIDSCREEN-27 at week 2
Tidsramme: Change from Baseline KIDCREEN-27 mean scores at 2 weeks
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The KIDSCREEN-27 is a 27-item variation of the KIDSCREEN-52 questionnaire that includes five dimensions of health-related quality of life (HRQOL).
It is a valid and reliable tool for assessing children's and adolescents' HRQOL outcomes
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Change from Baseline KIDCREEN-27 mean scores at 2 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Mintaze KEREM GUNLE, Hacettepe University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2022
Primær færdiggørelse (Faktiske)
1. april 2022
Studieafslutning (Faktiske)
1. maj 2022
Datoer for studieregistrering
Først indsendt
22. marts 2022
Først indsendt, der opfyldte QC-kriterier
5. april 2022
Først opslået (Faktiske)
6. april 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. maj 2022
Sidst verificeret
1. maj 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16969557-2167
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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