NCT04903067

Brief Summary

"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:

  1. 1.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.
  2. 2.Delphi study: which aims to develop a diet and physical activity intervention for children and young adult with JIA.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

May 21, 2021

Last Update Submit

May 28, 2021

Conditions

Keywords

Juvenile idiopathic arthritischildrenyoung peoplehealth-related quality of lifedietphysical activity

Outcome Measures

Primary Outcomes (1)

  • study one interviews

    views and opinions of participants

    one hour

Secondary Outcomes (1)

  • study two Delphi

    one hour

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Nuffield Orthopaedic Centre Oxford, Usual referral clinic.

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Najmeh Zare

Oxford, Oxfordshire, ox3obp, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arthritis, JuvenileMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Central Study Contacts

Najmeh Zare, phd student

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DPhill candidate

Study Record Dates

First Submitted

May 21, 2021

First Posted

May 26, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2022

Study Completion

December 30, 2022

Last Updated

June 2, 2021

Record last verified: 2021-05

Locations