- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03116763
The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis (iPeer2Peer)
24. Oktober 2022 aktualisiert von: 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).
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
262
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Stephanie Luca, HBSc, MA
- Telefonnummer: 309133 416-813-7654
- E-Mail: stephanie.luca@sickkids.ca
Studienorte
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Alberta
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Calgary, Alberta, Kanada, T3B 6A8
- Noch keine Rekrutierung
- Alberta Children's Hospital
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Kontakt:
- Nadia Luca, MD
- E-Mail: Nadia.Luca@albertahealthservices.ca
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British Columbia
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Vancouver, British Columbia, Kanada
- Rekrutierung
- BC Children's Hospital
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Kontakt:
- Lori Tucker, MD
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-
Nova Scotia
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Halifax, Nova Scotia, Kanada
- Rekrutierung
- The IWK Health Centre
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Kontakt:
- Adam Huber, MSc, MD
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Ontario
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London, Ontario, Kanada, N6A 5W9
- Noch keine Rekrutierung
- Children's Hospital - London Health Sciences
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Kontakt:
- Roberta Berard, MD
- E-Mail: Roberta.Berard@lhsc.on.ca
-
Ottawa, Ontario, Kanada
- Rekrutierung
- Children's Hospital of Eastern Ontario (CHEO)
-
Kontakt:
- Ciaran Duffy, MSc, FRCPC
-
Kontakt:
- Karen Watanabe Duffy, MD, FRCPC
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Unterermittler:
- Paula Forgeron, MD
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Unterermittler:
- Karen Watanabe Duffy, MD, FRCPC
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Toronto, Ontario, Kanada
- Rekrutierung
- The Hospital for Sick Children
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Kontakt:
- Jennifer Stinson, CPNP, PhD
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Unterermittler:
- Sara Ahola Kohut, PhD, CPsych
-
Unterermittler:
- Brian Feldman, MD, FRCPC
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Unterermittler:
- Lynn Spiegel, MD, FRCPC
-
Unterermittler:
- Myla Moretti, PhD
-
-
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
12 Jahre bis 18 Jahre (Kind, Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.
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Aktiver Komparator: Control Group
The control group will receive standard care but without the iPeer2Peer program.
|
The control group will receive standard care but without the iPeer2Peer program.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
TRANSITION-Q (measuring change)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
PedsQL Arthritis Module (measuring change)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Post-Intervention (approximately following 12 weeks of calls)
|
Mentor quality
|
Post-Intervention (approximately following 12 weeks of calls)
|
PROMIS Adult Profile (measuring change)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Jennifer N Stinson, CPNP, PhD, The Hospital for Sick Children
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)
28. März 2017
Primärer Abschluss (Voraussichtlich)
31. Mai 2023
Studienabschluss (Voraussichtlich)
30. September 2023
Studienanmeldedaten
Zuerst eingereicht
31. März 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. April 2017
Zuerst gepostet (Tatsächlich)
17. April 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
25. Oktober 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. Oktober 2022
Zuletzt verifiziert
1. Oktober 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1000054878
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 .
Klinische Studien zur Juvenile idiopathische Arthritis
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Istituto Giannina GasliniPfizer; Agenzia Italiana del Farmaco; Compagnia di San PaoloRekrutierungOligoarthritis, juvenil | Polyarthritis, juvenil, Rheumafaktor negativItalien
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University College London HospitalsRekrutierungArthritis, juvenile idiopathische | Enthesitis-assoziierte Arthritis, juvenilVereinigtes Königreich
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PfizerNoch keine RekrutierungPolyartikuläre juvenile idiopathische Arthritis | Psoriasis-Arthritis, juvenilKorea, Republik von
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National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiAbgeschlossenJuvenile rheumatoide ArthritisVereinigte Staaten
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University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)AbgeschlossenRheumatoide Arthritis | Juvenile rheumatoide ArthritisVereinigte Staaten
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University of Missouri-ColumbiaAbgeschlossenJuvenile rheumatoide ArthritisVereinigte Staaten
-
DePuy OrthopaedicsAbgeschlossenArthrose | Rheumatoide Arthritis | Posttraumatische Arthritis | Juvenile ArthritisVereinigte Staaten
-
Michael Rapoff, Ph.D.Abgeschlossen
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AmgenBeendetJuvenile rheumatoide Arthritis
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Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)AbgeschlossenJuvenile rheumatoide ArthritisVereinigte Staaten