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An Investigation Into the Relationship Between Dietary Intake and Health-related Quality of Life in Children and Young People With Juvenile Idiopathic Arthritis (JIA)

28. Mai 2021 aktualisiert von: Najmeh Zare, Oxford Brookes University

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

Studienübersicht

Status

Rekrutierung

Detaillierte Beschreibung

"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:

  1. Systematic review: to evaluate current evidence about diet, health and health related quality of life in children and young adult with JIA.
  2. 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.
  3. 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).

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

99

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

9 Jahre bis 18 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

Nuffield Orthopaedic Centre Oxford, Usual referral clinic.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
study one interviews
Zeitfenster: one hour
views and opinions of participants
one hour

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
study two Delphi
Zeitfenster: one hour
consensus of views and opinions
one hour

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Mai 2021

Primärer Abschluss (Voraussichtlich)

1. Mai 2022

Studienabschluss (Voraussichtlich)

30. Dezember 2022

Studienanmeldedaten

Zuerst eingereicht

21. Mai 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Mai 2021

Zuerst gepostet (Tatsächlich)

26. Mai 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juni 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Mai 2021

Zuletzt verifiziert

1. Mai 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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