search
Back to results

Virtual Peer-to-Peer (VP2P) Support Mentoring for Chronic Pain: A Pilot RCT

Primary Purpose

Chronic Pain

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 Chronic Pain 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 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).

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

Waitlist 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 chronic pain aged 16-25 years who have learned to function successfully with their chronic pain 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 Chronic Pain VP2P Program - the acceptability of and satisfaction with the Chronic Pain 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 61-item Bath Adolescent Pain Questionnaire, which assesses the impact of chronic pain in adolescence in terms of physical, psychological and social functioning.
Emotional Symptoms
Anxiety and depression will each be assessed using two, separate 8-item Patient Reported Outcomes Measurement Information System (PROMIS) scales.
Pain Coping
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.
Self-Efficacy
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.
Social Support
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.
Disability
Disability will be measured using the 15-item Functional Disability Inventory, which assesses physical functioning and disability in youth with chronic pain.
Self-Management
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).
Pain
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.

Full Information

First Posted
November 11, 2013
Last Updated
December 29, 2017
Sponsor
The Hospital for Sick Children
search

1. Study Identification

Unique Protocol Identification Number
NCT01986387
Brief Title
Virtual Peer-to-Peer (VP2P) Support Mentoring for Chronic Pain: A Pilot RCT
Official Title
Virtual Peer-to-Peer (VP2P) Support Mentoring for Adolescents With Chronic Pain: 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 chronic pain.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
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 chronic pain aged 16-25 years who have learned to function successfully with their chronic pain to the mentored participants).
Arm Title
Waitlist 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 Chronic Pain VP2P Program - the acceptability of and satisfaction with the Chronic Pain 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 61-item Bath Adolescent Pain Questionnaire, which assesses the impact of chronic pain in adolescence in terms of physical, psychological and social functioning.
Time Frame
Baseline, 2 months
Title
Emotional Symptoms
Description
Anxiety and depression will each be assessed using two, separate 8-item Patient Reported Outcomes Measurement Information System (PROMIS) scales.
Time Frame
Baseline, 2 months
Title
Pain Coping
Description
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.
Time Frame
Baseline, 2 months
Title
Self-Efficacy
Description
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.
Time Frame
Baseline, 2 months
Title
Social Support
Description
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.
Time Frame
Baseline, 2 months
Title
Disability
Description
Disability will be measured using the 15-item Functional Disability Inventory, which assesses physical functioning and disability in youth with chronic pain.
Time Frame
Baseline, 2 months
Title
Self-Management
Description
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).
Time Frame
Baseline, 2 months
Title
Pain
Description
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.
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 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).
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
26808145
Citation
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.
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
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

Learn more about this trial

Virtual Peer-to-Peer (VP2P) Support Mentoring for Chronic Pain: A Pilot RCT

We'll reach out to this number within 24 hrs