- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01986387
Virtual Peer-to-Peer (VP2P) Support Mentoring for Chronic Pain: A Pilot RCT
December 29, 2017 updated by: Jennifer Stinson, The Hospital for Sick Children
Virtual Peer-to-Peer (VP2P) Support Mentoring for Adolescents With Chronic Pain: 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 chronic pain.
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 chronic pain 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
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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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 chronic pain condition (e.g., neuropathic pain, Complex Regional Pain Syndrome, chronic musculoskeletal pain, chronic daily headache, chronic widespread pain)
- 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., WebMap).
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 chronic pain aged 16-25 years who have learned to function successfully with their chronic pain to the mentored participants).
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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).
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No Intervention: Waitlist 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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility
Time Frame: 2 months
|
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2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-Related Quality of Life (HRQL)
Time Frame: Baseline, 2 months
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HRQL will be measured by using the 61-item Bath Adolescent Pain Questionnaire, which assesses the impact of chronic pain in adolescence in terms of physical, psychological and social functioning.
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Baseline, 2 months
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Emotional Symptoms
Time Frame: Baseline, 2 months
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Anxiety and depression will each be assessed using two, separate 8-item Patient Reported Outcomes Measurement Information System (PROMIS) scales.
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Baseline, 2 months
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Pain Coping
Time Frame: Baseline, 2 months
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Pain coping will be measured using the 18-item Pain Coping Questionnaire, which is an internationally used measure of pain coping strategies in the pediatric population.
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Baseline, 2 months
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Self-Efficacy
Time Frame: Baseline, 2 months
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Self-efficacy will be measured using a 10-item Pain Self-Efficacy Questionnaire (PSEQ) that assesses the confidence people have in performing activities while in pain.
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Baseline, 2 months
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Social Support
Time Frame: Baseline, 2 months
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Social support will be measured with the 12-item Multidimensional Scale of Perceived Social Support questionnaire that explores the impact that family, friends and significant others as social support.
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Baseline, 2 months
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Disability
Time Frame: Baseline, 2 months
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Disability will be measured using the 15-item Functional Disability Inventory, which assesses physical functioning and disability in youth with chronic pain.
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Baseline, 2 months
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Self-Management
Time Frame: Baseline, 2 months
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Self-management was measured using Self-Management Skills Assessment Guide, which was developed by Alberta Children's Hospital and consists of 21 items assessing adolescents' awareness of their health condition and ability to make decisions relevant to their health care needs (cite).
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Baseline, 2 months
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Pain
Time Frame: Baseline, 2 months
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Pain will be measured using the Brief Pain Inventory - Short Form (BPISF).
The 9-item measure assesses the severity of pain and its impact on daily functions.
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Baseline, 2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- 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.
- Ahola Kohut S, Stinson JN, Ruskin D, Forgeron P, Harris L, van Wyk M, Luca S, Campbell F. iPeer2Peer program: a pilot feasibility study in adolescents with chronic pain. Pain. 2016 May;157(5):1146-1155. doi: 10.1097/j.pain.0000000000000496.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000036188
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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