Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

24 oktober 2022 bijgewerkt door: 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).

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Verwacht)

262

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Werving
        • BC Children's Hospital
        • Contact:
          • Lori Tucker, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Werving
        • The IWK Health Centre
        • Contact:
          • Adam Huber, MSc, MD
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Nog niet aan het werven
        • Children's Hospital - London Health Sciences
        • Contact:
      • Ottawa, Ontario, Canada
        • Werving
        • Children's Hospital of Eastern Ontario (CHEO)
        • Contact:
          • Ciaran Duffy, MSc, FRCPC
        • Contact:
          • Karen Watanabe Duffy, MD, FRCPC
        • Onderonderzoeker:
          • Paula Forgeron, MD
        • Onderonderzoeker:
          • Karen Watanabe Duffy, MD, FRCPC
      • Toronto, Ontario, Canada
        • Werving
        • The Hospital for Sick Children
        • Contact:
          • Jennifer Stinson, CPNP, PhD
        • Onderonderzoeker:
          • Sara Ahola Kohut, PhD, CPsych
        • Onderonderzoeker:
          • Brian Feldman, MD, FRCPC
        • Onderonderzoeker:
          • Lynn Spiegel, MD, FRCPC
        • Onderonderzoeker:
          • Myla Moretti, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: iPeer2Peer Mentorship
10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.
Actieve vergelijker: Control Group
The control group will receive standard care but without the iPeer2Peer program.
Ander: Active Comparator: Control Group
The control group will receive standard care but without the iPeer2Peer program.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
TRANSITION-Q (measuring change)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PedsQL Arthritis Module (measuring change)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Post-Intervention (approximately following 12 weeks of calls)
Mentor quality
Post-Intervention (approximately following 12 weeks of calls)
PROMIS Adult Profile (measuring change)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Hospital for Sick Children

Medewerkers

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

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 maart 2017

Primaire voltooiing (Verwacht)

31 mei 2023

Studie voltooiing (Verwacht)

30 september 2023

Studieregistratiedata

Eerst ingediend

31 maart 2017

Eerst ingediend dat voldeed aan de QC-criteria

11 april 2017

Eerst geplaatst (Werkelijk)

17 april 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 oktober 2022

Laatste update ingediend die voldeed aan QC-criteria

24 oktober 2022

Laatst geverifieerd

1 oktober 2022

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1000054878

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Juveniele idiopathische artritis

Klinische onderzoeken op iPeer2Peer Mentorship

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Mauritania

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

Abonneren