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Virtual Peer-to-Peer (VP2P) Support Mentoring for Juvenile Idiopathic Arthritis (JIA): A Pilot RCT

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Peer-to-Peer Support Mentoring
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Juvenile Idiopathic Arthritis focused on measuring Adolescent, Skype, Peer Mentorship, Internet Self-Management

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • males and females 12-18 years old
  • diagnosed with Juvenile Idiopathic Arthritis (JIA) by a Rheumatologist (any sub-type)
  • able to speak and read English
  • access to Internet connection, computer capable of using free Skype software
  • willing and able to complete online measures

Exclusion Criteria:

  • significant cognitive impairments
  • major co-morbid illnesses (i.e., psychiatric conditions) likely to influence HRQL assessment
  • participating in peer support or self-management interventions (e.g., Teens Taking Charge).

Sites / Locations

  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Peer-to-Peer Support Mentoring

Wait-list Control

Arm Description

In addition to standard medical care, adolescents in the experimental group will receive the VP2P support program, a manualized peer-mentorship program that will provide modeling and reinforcement by peers (young adults with JIA aged 16-25 years who have learned to function successfully with their JIA to the mentored participants).

The control group will receive usual care but without the mentorship intervention. They will be offered the VP2P support program after completion of outcome measures (T1 - to be completed online prior to randomization; T2 - at program completion).

Outcomes

Primary Outcome Measures

Feasibility
Accrual and Dropout Rates - recruitment and withdrawal rates will be calculated that the end of the study. Compliance (Level of Engagement) - rates of completion of weekly calls and online outcome measures will be calculated that the end of the study - defined as 100% when the participant completes 10 calls over 8 weeks with all online measures completed. Adolescents' Perception of JIA VP2P Program - the acceptability of and satisfaction with the JIA VP2P support program as measured through semi-structured phone interviews with mentees and focus groups with mentors Estimates of Intervention Effects (e.g., effect sizes, variance measures/standard deviation) on health outcomes to inform the calculation of an appropriate sample size for the future definitive multi-centred randomized controlled trial (RCT)

Secondary Outcome Measures

Health-Related Quality of Life (HRQL)
HRQL will be measured by using the Pediatric Quality of Life (PedsQL) Arthritis Module, a 22-item self-report scale which assesses the impact of arthritis in adolescents in terms of physical, psychological and social functioning.
Pain
The Recalled Pain Inventory (RPI) measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference with 38-items rated on a 11-point numerical rating scale (NRS).
Knowledge and Social Support
The Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) is a 24-tem measure used to assess knowledge and social support.
Self-Efficacy
Self-efficacy is assessed using the Children's Arthritis Self-Efficacy (CASE) 11-item measure, measuring symptom management, emotional consequences and activities related to their arthritis.
Adherence
Adherence (or compliance) to prescribed medications, exercises and wearing of splints assessed using the Child Adherence Report Questionnaire (CARQ).

Full Information

First Posted
November 11, 2013
Last Updated
December 29, 2017
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01986400
Brief Title
Virtual Peer-to-Peer (VP2P) Support Mentoring for Juvenile Idiopathic Arthritis (JIA): A Pilot RCT
Official Title
Virtual Peer-to-Peer Support Mentoring for Adolescents With Juvenile Idiopathic Arthritis: A Feasibility Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes and quality of life in adolescents with Juvenile Idiopathic Arthritis
Detailed Description
The aim of this project is to develop and examine the impact of a virtual peer support program on health outcomes and quality of life of adolescents with Juvenile Idiopathic Arthritis using a waitlist randomized controlled trial. In addition to standard medical care, adolescents in the experimental group will receive a manualized peer mentorship program that will provide modeling and reinforcement by trained young adults aged 16-25 years who have learned to function successfully with their pain. Mentoring sessions consist of 10 sessions of 30-45 minute Skype calls over 8 weeks. Feasibility of the program will be measured in addition to quality of life, physical and emotional symptoms, pain coping, self-efficacy, social support, and self-management skills.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
Adolescent, Skype, Peer Mentorship, Internet Self-Management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Peer-to-Peer Support Mentoring
Arm Type
Experimental
Arm Description
In addition to standard medical care, adolescents in the experimental group will receive the VP2P support program, a manualized peer-mentorship program that will provide modeling and reinforcement by peers (young adults with JIA aged 16-25 years who have learned to function successfully with their JIA to the mentored participants).
Arm Title
Wait-list Control
Arm Type
No Intervention
Arm Description
The control group will receive usual care but without the mentorship intervention. They will be offered the VP2P support program after completion of outcome measures (T1 - to be completed online prior to randomization; T2 - at program completion).
Intervention Type
Behavioral
Intervention Name(s)
Virtual Peer-to-Peer Support Mentoring
Intervention Description
The mentorship program will encourage mentored participants to develop and engage in self-management and transition skills and support their practice of these skills. The mentors will present information to mentored participants in a monitored virtual interaction using Skype for 8 weeks (10 total Skype sessions of 30-60 minutes each) to encourage participation in skill building tailored to their needs. All mentors will complete a paid 2.5 day training course and will be supported throughout the duration of the study (consultations with research staff to deal with unforeseen concerns). Mentored participants will complete online outcome measures prior to randomization (T1) and upon study completion (T2).
Primary Outcome Measure Information:
Title
Feasibility
Description
Accrual and Dropout Rates - recruitment and withdrawal rates will be calculated that the end of the study. Compliance (Level of Engagement) - rates of completion of weekly calls and online outcome measures will be calculated that the end of the study - defined as 100% when the participant completes 10 calls over 8 weeks with all online measures completed. Adolescents' Perception of JIA VP2P Program - the acceptability of and satisfaction with the JIA VP2P support program as measured through semi-structured phone interviews with mentees and focus groups with mentors Estimates of Intervention Effects (e.g., effect sizes, variance measures/standard deviation) on health outcomes to inform the calculation of an appropriate sample size for the future definitive multi-centred randomized controlled trial (RCT)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Health-Related Quality of Life (HRQL)
Description
HRQL will be measured by using the Pediatric Quality of Life (PedsQL) Arthritis Module, a 22-item self-report scale which assesses the impact of arthritis in adolescents in terms of physical, psychological and social functioning.
Time Frame
Baseline, 2 months
Title
Pain
Description
The Recalled Pain Inventory (RPI) measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference with 38-items rated on a 11-point numerical rating scale (NRS).
Time Frame
Baseline, 2 months
Title
Knowledge and Social Support
Description
The Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) is a 24-tem measure used to assess knowledge and social support.
Time Frame
Baseline, 2 Months
Title
Self-Efficacy
Description
Self-efficacy is assessed using the Children's Arthritis Self-Efficacy (CASE) 11-item measure, measuring symptom management, emotional consequences and activities related to their arthritis.
Time Frame
Baseline, 2 Months
Title
Adherence
Description
Adherence (or compliance) to prescribed medications, exercises and wearing of splints assessed using the Child Adherence Report Questionnaire (CARQ).
Time Frame
Baseline, 2 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: males and females 12-18 years old diagnosed with Juvenile Idiopathic Arthritis (JIA) by a Rheumatologist (any sub-type) able to speak and read English access to Internet connection, computer capable of using free Skype software willing and able to complete online measures Exclusion Criteria: significant cognitive impairments major co-morbid illnesses (i.e., psychiatric conditions) likely to influence HRQL assessment participating in peer support or self-management interventions (e.g., Teens Taking Charge).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer N Stinson, RN,PhD,CPNP
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27590668
Citation
Stinson J, Ahola Kohut S, Forgeron P, Amaria K, Bell M, Kaufman M, Luca N, Luca S, Harris L, Victor C, Spiegel L. The iPeer2Peer Program: a pilot randomized controlled trial in adolescents with Juvenile Idiopathic Arthritis. Pediatr Rheumatol Online J. 2016 Sep 2;14(1):48. doi: 10.1186/s12969-016-0108-2.
Results Reference
result
PubMed Identifier
27682341
Citation
Ahola Kohut S, Stinson J, Forgeron P, van Wyk M, Harris L, Luca S. A qualitative content analysis of peer mentoring video calls in adolescents with chronic illness. J Health Psychol. 2018 May;23(6):788-799. doi: 10.1177/1359105316669877. Epub 2016 Sep 28.
Results Reference
result
PubMed Identifier
28340203
Citation
Ahola Kohut S, Stinson J, Forgeron P, Luca S, Harris L. Been There, Done That: The Experience of Acting as a Young Adult Mentor to Adolescents Living With Chronic Illness. J Pediatr Psychol. 2017 Oct 1;42(9):962-969. doi: 10.1093/jpepsy/jsx062.
Results Reference
result

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Virtual Peer-to-Peer (VP2P) Support Mentoring for Juvenile Idiopathic Arthritis (JIA): A Pilot RCT

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