The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis (iPeer2Peer)
2022년 10월 24일 업데이트: 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).
연구 개요
상세 설명
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).
연구 유형
중재적
등록 (예상)
262
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Stephanie Luca, HBSc, MA
- 전화번호: 309133 416-813-7654
- 이메일: stephanie.luca@sickkids.ca
연구 장소
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Alberta
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Calgary, Alberta, 캐나다, T3B 6A8
- 아직 모집하지 않음
- Alberta Children's Hospital
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연락하다:
- Nadia Luca, MD
- 이메일: Nadia.Luca@albertahealthservices.ca
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British Columbia
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Vancouver, British Columbia, 캐나다
- 모병
- BC Children's Hospital
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연락하다:
- Lori Tucker, MD
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Nova Scotia
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Halifax, Nova Scotia, 캐나다
- 모병
- The IWK Health Centre
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연락하다:
- Adam Huber, MSc, MD
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Ontario
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London, Ontario, 캐나다, N6A 5W9
- 아직 모집하지 않음
- Children's Hospital - London Health Sciences
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연락하다:
- Roberta Berard, MD
- 이메일: Roberta.Berard@lhsc.on.ca
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Ottawa, Ontario, 캐나다
- 모병
- Children's Hospital of Eastern Ontario (CHEO)
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연락하다:
- Ciaran Duffy, MSc, FRCPC
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연락하다:
- Karen Watanabe Duffy, MD, FRCPC
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부수사관:
- Paula Forgeron, MD
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부수사관:
- Karen Watanabe Duffy, MD, FRCPC
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Toronto, Ontario, 캐나다
- 모병
- The Hospital for Sick Children
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연락하다:
- Jennifer Stinson, CPNP, PhD
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부수사관:
- Sara Ahola Kohut, PhD, CPsych
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부수사관:
- Brian Feldman, MD, FRCPC
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부수사관:
- Lynn Spiegel, MD, FRCPC
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부수사관:
- Myla Moretti, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
12년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.
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활성 비교기: Control Group
The control group will receive standard care but without the iPeer2Peer program.
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The control group will receive standard care but without the iPeer2Peer program.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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TRANSITION-Q (measuring change)
기간: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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14-item measure of self-management skills that is both reliable (internally consistent, test-retest) and valid (face, construct and content validity)
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PedsQL Arthritis Module (measuring change)
기간: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Health-related quality of life
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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PROMIS Pain Interference (measuring change)
기간: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Pain
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Screen for Child Anxiety Related Disorders (measuring change)
기간: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Emotional distress
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Center for Epidemiologic Studies Depression Scale Revised (measuring change)
기간: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Emotional distress
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)
기간: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Disease knowledge
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Children's Arthritis Self-Efficacy (measuring change)
기간: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Self-efficacy
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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PROMIS Pediatric Peer Relationship Scale (measuring change)
기간: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Perceived social support
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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AQoL-6D, interview (measuring change)
기간: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Cost utility analysis
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Health service use and costs (measuring change)
기간: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Cost utility analysis
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Mentor Behavior Scale (measuring change)
기간: Post-Intervention (approximately following 12 weeks of calls)
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Mentor quality
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Post-Intervention (approximately following 12 weeks of calls)
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PROMIS Adult Profile (measuring change)
기간: At beginning of study and at end of study (approximately 3 years later)
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For mentors only: mentor physical and emotional symptoms
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At beginning of study and at end of study (approximately 3 years later)
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PROMIS Satisfaction with Social Roles and Activities (measuring change)
기간: At beginning of study and at end of study (approximately 3 years later)
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For mentors only: perceived social role satisfaction
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At beginning of study and at end of study (approximately 3 years later)
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Chronic Disease Self-Efficacy Scale (measuring change)
기간: At beginning of study and at end of study (approximately 3 years later)
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For mentors only: self-efficacy
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At beginning of study and at end of study (approximately 3 years later)
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Mentor interaction form
기간: Following completion of each mentee's calls (approximately following 12 weeks of calls)
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Record of interactions with mentees
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Following completion of each mentee's calls (approximately following 12 weeks of calls)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jennifer N Stinson, CPNP, PhD, The Hospital for Sick Children
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 3월 28일
기본 완료 (예상)
2023년 5월 31일
연구 완료 (예상)
2023년 9월 30일
연구 등록 날짜
최초 제출
2017년 3월 31일
QC 기준을 충족하는 최초 제출
2017년 4월 11일
처음 게시됨 (실제)
2017년 4월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 10월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 10월 24일
마지막으로 확인됨
2022년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
청소년 특발성 관절염에 대한 임상 시험
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Azienda Unita Sanitaria Locale di PiacenzaUniversity of Parma모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)체코, 이탈리아
iPeer2Peer Mentorship에 대한 임상 시험
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The Hospital for Sick ChildrenUniversity of Alberta/Stollery Children's Hospital; The Centre Hospitalier Universitaire...모병
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The Hospital for Sick ChildrenChildren's Hospital of Eastern Ontario; Royal University Hospital Foundation; Connecticut...모집하지 않고 적극적으로
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The Hospital for Sick ChildrenEnduring Hearts; University of Alberta/Stollery Children's Hospital완전한