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

24 oktober 2022 uppdaterad 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).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Förväntat)

262

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kanada
    • Alberta
    • British Columbia
      • Vancouver, British Columbia, Kanada
        • Rekrytering
        • BC Children's Hospital
        • Kontakt:
          • Lori Tucker, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada
        • Rekrytering
        • The IWK Health Centre
        • Kontakt:
          • Adam Huber, MSc, MD
    • Ontario
      • London, Ontario, Kanada, N6A 5W9
        • Har inte rekryterat ännu
        • Children's Hospital - London Health Sciences
        • Kontakt:
      • Ottawa, Ontario, Kanada
        • Rekrytering
        • Children's Hospital of Eastern Ontario (CHEO)
        • Kontakt:
          • Ciaran Duffy, MSc, FRCPC
        • Kontakt:
          • Karen Watanabe Duffy, MD, FRCPC
        • Underutredare:
          • Paula Forgeron, MD
        • Underutredare:
          • Karen Watanabe Duffy, MD, FRCPC
      • Toronto, Ontario, Kanada
        • Rekrytering
        • The Hospital for Sick Children
        • Kontakt:
          • Jennifer Stinson, CPNP, PhD
        • Underutredare:
          • Sara Ahola Kohut, PhD, CPsych
        • Underutredare:
          • Brian Feldman, MD, FRCPC
        • Underutredare:
          • Lynn Spiegel, MD, FRCPC
        • Underutredare:
          • Myla Moretti, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Övrig: Active Comparator: Control Group
The control group will receive standard care but without the iPeer2Peer program.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
TRANSITION-Q (measuring change)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
PedsQL Arthritis Module (measuring change)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Post-Intervention (approximately following 12 weeks of calls)
Mentor quality
Post-Intervention (approximately following 12 weeks of calls)
PROMIS Adult Profile (measuring change)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Hospital for Sick Children

Samarbetspartners

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

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 mars 2017

Primärt slutförande (Förväntat)

31 maj 2023

Avslutad studie (Förväntat)

30 september 2023

Studieregistreringsdatum

Först inskickad

31 mars 2017

Först inskickad som uppfyllde QC-kriterierna

11 april 2017

Första postat (Faktisk)

17 april 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 oktober 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 oktober 2022

Senast verifierad

1 oktober 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1000054878

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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Kliniska prövningar på iPeer2Peer Mentorship

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