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

December 29, 2017 updated by: Jennifer Stinson, The Hospital for Sick Children

Virtual Peer-to-Peer Support Mentoring for Adolescents With Juvenile Idiopathic Arthritis: A Feasibility Pilot Randomized Controlled Trial

Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes and quality of life in adolescents with Juvenile Idiopathic Arthritis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Peer-to-Peer Support Mentoring
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).
Behavioral: Virtual Peer-to-Peer Support Mentoring
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).
No Intervention: Wait-list Control
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 2 months
  1. Accrual and Dropout Rates - recruitment and withdrawal rates will be calculated that the end of the study.
  2. 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.
  3. 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
  4. 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)
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life (HRQL)
Time Frame: Baseline, 2 months
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.
Baseline, 2 months
Pain
Time Frame: Baseline, 2 months
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).
Baseline, 2 months
Knowledge and Social Support
Time Frame: Baseline, 2 Months
The Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) is a 24-tem measure used to assess knowledge and social support.
Baseline, 2 Months
Self-Efficacy
Time Frame: Baseline, 2 Months
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.
Baseline, 2 Months
Adherence
Time Frame: Baseline, 2 Months
Adherence (or compliance) to prescribed medications, exercises and wearing of splints assessed using the Child Adherence Report Questionnaire (CARQ).
Baseline, 2 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Jennifer N Stinson, RN,PhD,CPNP, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 29, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000038163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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