- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
상세 설명
"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).
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Najmeh Zare, phd student
- 전화번호: +4401865483293
- 이메일: 18106168@brookes.ac.uk
연구 연락처 백업
- 이름: Sarah Quiinton, Dr
- 전화번호: +44 (0) 1865 485694
- 이메일: sequinton@brookes.ac.uk
연구 장소
-
-
Oxfordshire
-
Oxford, Oxfordshire, 영국, ox3obp
- 모병
- Najmeh Zare
-
연락하다:
- Sarah Quinton, Dr
- 전화번호: +44 (0) 1865 485694
- 이메일: sequinton@brookes.ac.uk
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
study one interviews
기간: one hour
|
views and opinions of participants
|
one hour
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
study two Delphi
기간: one hour
|
consensus of views and opinions
|
one hour
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .