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

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986400
• Other study ID #: 1000038163
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: December 29, 2017
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2017
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

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).

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. 2016 Sep 1:1359105316669877. doi: 10.1177/1359105316669877. [Epub ahead — View 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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 months
Secondary	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.	Baseline, 2 months
Secondary	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).	Baseline, 2 months
Secondary	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.	Baseline, 2 Months
Secondary	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.	Baseline, 2 Months
Secondary	Adherence	Adherence (or compliance) to prescribed medications, exercises and wearing of splints assessed using the Child Adherence Report Questionnaire (CARQ).	Baseline, 2 Months