- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04903067
An Investigation Into the Relationship Between Dietary Intake and Health-related Quality of Life in Children and Young People With Juvenile Idiopathic Arthritis (JIA)
"Physical activity and diet in children and young people with arthritis" A qualitative study of exploring stake holder's experiences.
Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis in children under the age of 16. The disease and its therapeutic management can cause serious long-term complications, which affect general activities and quality of life. The lack of specific guidelines for safe physical activity and appropriate management of any nutritional deficit aiming our study to find out your views and opinions about the needs of children and young people with juvenile idiopathic arthritis. We want to improve our knowledge about the impact of physical activity and eating habit on juvenile idiopathic arthritis and we want to develop a tool to help evaluate care. Few studies targeting quality of life and wellbeing in children adolescent populations have adopted the diet and physical activity perspective or approaches, consequently, this research project will help to address this gap through:
- Interview: to look at young people's current experiences with JIA as well as their parents/caregivers and health care professionals. Study findings will provide a snapshot of the current experiences of participants, helping to improve our knowledge about JIA, physical activity, and diet. Qualitative studies exploring people perspectives on their experiences, when collected systematically, adds valuable depth, insight and understanding into the issues related to JIA not possible through quantitative methodologies. This study uses a qualitative approach known as framework methodology to understand stakeholder's experience of what helps and what hinders improving the quality of life in children and young adult with JIA. 21-30 stakeholders will be recruited in Oxford UK, to take part in individual semi-structured guided interviews lasting approximately one hour. Participant responses will be transcribed by the chief investigator and analysed to extract themes that will answer the research question.
- Delphi study: which aims to develop a diet and physical activity intervention for children and young adult with JIA.
Přehled studie
Postavení
Podmínky
Detailní popis
"Physical activity and diet in children and young people with arthritis" A qualitative study of exploring stake holder's experiences.
Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis in children under the age of 16. The disease and its therapeutic management can cause serious long-term complications, which affect general activities and quality of life. The lack of specific guidelines for safe physical activity and appropriate management of any nutritional deficit aiming our study to find out your views and opinions about the needs of children and young people with juvenile idiopathic arthritis. We want to improve our knowledge about the impact of physical activity and eating habit on juvenile idiopathic arthritis and we want to develop a tool to help evaluate care. Few studies targeting quality of life and wellbeing in children adolescent populations have adopted diet and physical activity perspective or approaches, consequently this research project will help to address this gap through:
- Systematic review: to evaluate current evidence about diet, health and health related quality of life in children and young adult with JIA.
- Interview: to look at young people's current experiences with JIA as well as their parents/caregivers and health care professionals. Study findings will provide a snapshot of current experiences of participants, helping to improve our knowledge about JIA, physical activity, and diet. Qualitative studies exploring people perspectives on their experiences, when collected systematically, adds valuable depth, insight and understanding into the issues related to JIA not possible through quantitative methodologies. This study uses a qualitative approach known as framework methodology to understand stakeholder's experience of what helps and what hinders improving the quality of life in children and young adult with JIA. 21-30 stakeholders will be recruited in Oxford UK, to take part in individual semi-structured guided interviews lasting approximately one hour. Participant responses will be transcribed by the chief investigator (PhD student) and analysed to extract themes that will answer the research question.
- Delphi study: which aims to develop diet and physical activity intervention for children and young adult with JIA.
This protocol covers the second and third approaches only (interview and Delphi).
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Najmeh Zare, phd student
- Telefonní číslo: +4401865483293
- E-mail: 18106168@brookes.ac.uk
Studijní záloha kontaktů
- Jméno: Sarah Quiinton, Dr
- Telefonní číslo: +44 (0) 1865 485694
- E-mail: sequinton@brookes.ac.uk
Studijní místa
-
-
Oxfordshire
-
Oxford, Oxfordshire, Spojené království, ox3obp
- Nábor
- Najmeh Zare
-
Kontakt:
- Sarah Quinton, Dr
- Telefonní číslo: +44 (0) 1865 485694
- E-mail: sequinton@brookes.ac.uk
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
A) Patients
- Male or female, age range 9 to 18 years old.
- Diagnosed with JIA.
- Speaking and understanding English.
- Willing and able to provide consent if 16-18 years old, or have a parent/carer to provide consent and able to provide assent if the participant is <16.
- Having the access to telephone/video call for those who wish to have distance interview.
B) Parent/Carer
- parent or caregiver of a child with JIA.
- Willing and able to give informed consent for their own and their child's participation (if the child is under 16 years of age).
- Having the access to telephone/video call for those who wish to have distance interview.
- Speaking and understanding English. C) Healthcare professionals
- Willing and able to give informed consent.
- Clinical HCP with at least 2-year experience in treating children and young people with JIA.
- Academic in the field of clinical research in the treatment of JIA.
- Having the access to telephone/video call for those who wish to have distance interview.
- Speaking and understanding English.
Exclusion Criteria:
Individuals will be excluded from the study if ANY of the following apply:
A) Patient
- They have been diagnosed JIA but older than 18 years old.
- Unable to speak and understand English. B) Healthcare professionals
HCP with insufficient experience in JIA management.
- They have less than two years of managing/treating JIA patients.
- They have worked in this field but have stopped for two years or more.
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
study one interviews
Časové okno: one hour
|
views and opinions of participants
|
one hour
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
study two Delphi
Časové okno: one hour
|
consensus of views and opinions
|
one hour
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 110611
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .