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The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis (iPeer2Peer)

24. oktober 2022 oppdatert av: Jennifer Stinson, The Hospital for Sick Children

The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial

The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Arthritis is a common childhood illness that makes everyday activities hard for young people. It is a long-lasting illness that can make you feel pain, tired and emotionally upset. This can make it hard for children and teens to see friends and do the activities that they like. The goal of this project is to find out if the newly developed peer mentoring program called iPeer2Peer helps teens with arthritis take better care of their illness and feel more connected to other people with arthritis. The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor).

Studietype

Intervensjonell

Registrering (Forventet)

262

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Canada
    • Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Rekruttering
        • BC Children's Hospital
        • Ta kontakt med:
          • Lori Tucker, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Rekruttering
        • The IWK Health Centre
        • Ta kontakt med:
          • Adam Huber, MSc, MD
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Har ikke rekruttert ennå
        • Children's Hospital - London Health Sciences
        • Ta kontakt med:
      • Ottawa, Ontario, Canada
        • Rekruttering
        • Children's Hospital of Eastern Ontario (CHEO)
        • Ta kontakt med:
          • Ciaran Duffy, MSc, FRCPC
        • Ta kontakt med:
          • Karen Watanabe Duffy, MD, FRCPC
        • Underetterforsker:
          • Paula Forgeron, MD
        • Underetterforsker:
          • Karen Watanabe Duffy, MD, FRCPC
      • Toronto, Ontario, Canada
        • Rekruttering
        • The Hospital for Sick Children
        • Ta kontakt med:
          • Jennifer Stinson, CPNP, PhD
        • Underetterforsker:
          • Sara Ahola Kohut, PhD, CPsych
        • Underetterforsker:
          • Brian Feldman, MD, FRCPC
        • Underetterforsker:
          • Lynn Spiegel, MD, FRCPC
        • Underetterforsker:
          • Myla Moretti, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • males and females 12-18 years old
  • rheumatologist-diagnosed JIA according to ILAR criteria
  • able to speak and read English
  • access to a computer, smartphone or tablet capable of using free Skype software (note: participants who do not have adequate Internet access will be provided with portable Internet sticks)
  • willing and able to complete online measures.

Exclusion Criteria:

  • significant cognitive impairments
  • major co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment
  • participating in other peer support or self-management interventions.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: iPeer2Peer Mentorship
In addition to standard care, youth in the experimental group will receive the iPeer2Peer program, a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with JIA aged 18-22 years who have learned to function successfully with their disease). Mentors will encourage participants to develop and engage in self-management skills and provide social support.
Atferdsmessig: iPeer2Peer Mentorship
10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.
Aktiv komparator: Control Group
The control group will receive standard care but without the iPeer2Peer program.
Annen: Active Comparator: Control Group
The control group will receive standard care but without the iPeer2Peer program.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
TRANSITION-Q (measuring change)
Tidsramme: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
14-item measure of self-management skills that is both reliable (internally consistent, test-retest) and valid (face, construct and content validity)
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PedsQL Arthritis Module (measuring change)
Tidsramme: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Health-related quality of life
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
PROMIS Pain Interference (measuring change)
Tidsramme: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Pain
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Screen for Child Anxiety Related Disorders (measuring change)
Tidsramme: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Emotional distress
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Center for Epidemiologic Studies Depression Scale Revised (measuring change)
Tidsramme: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Emotional distress
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)
Tidsramme: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Disease knowledge
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Children's Arthritis Self-Efficacy (measuring change)
Tidsramme: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Self-efficacy
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
PROMIS Pediatric Peer Relationship Scale (measuring change)
Tidsramme: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Perceived social support
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
AQoL-6D, interview (measuring change)
Tidsramme: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Cost utility analysis
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Health service use and costs (measuring change)
Tidsramme: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Cost utility analysis
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Mentor Behavior Scale (measuring change)
Tidsramme: Post-Intervention (approximately following 12 weeks of calls)
Mentor quality
Post-Intervention (approximately following 12 weeks of calls)
PROMIS Adult Profile (measuring change)
Tidsramme: At beginning of study and at end of study (approximately 3 years later)
For mentors only: mentor physical and emotional symptoms
At beginning of study and at end of study (approximately 3 years later)
PROMIS Satisfaction with Social Roles and Activities (measuring change)
Tidsramme: At beginning of study and at end of study (approximately 3 years later)
For mentors only: perceived social role satisfaction
At beginning of study and at end of study (approximately 3 years later)
Chronic Disease Self-Efficacy Scale (measuring change)
Tidsramme: At beginning of study and at end of study (approximately 3 years later)
For mentors only: self-efficacy
At beginning of study and at end of study (approximately 3 years later)
Mentor interaction form
Tidsramme: Following completion of each mentee's calls (approximately following 12 weeks of calls)
Record of interactions with mentees
Following completion of each mentee's calls (approximately following 12 weeks of calls)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Hospital for Sick Children

Samarbeidspartnere

Children's Hospital of Eastern Ontario
IWK Health Centre
Provincial Health Services Authority

Etterforskere

  • Hovedetterforsker: Jennifer N Stinson, CPNP, PhD, The Hospital for Sick Children

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. mars 2017

Primær fullføring (Forventet)

31. mai 2023

Studiet fullført (Forventet)

30. september 2023

Datoer for studieregistrering

Først innsendt

31. mars 2017

Først innsendt som oppfylte QC-kriteriene

11. april 2017

Først lagt ut (Faktiske)

17. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. oktober 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. oktober 2022

Sist bekreftet

1. oktober 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1000054878

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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