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

NCT01986387 | Completed

• 1 other identifier: 1000036188
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes and quality of life in adolescents with chronic pain.

Conditions

Chronic Pain

Keywords

adolescent; Skype; peer mentorship; internet self-management

Outcome Measures

Primary Outcomes (1)

• Feasibility

  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 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 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 Outcomes (8)

• Health-Related Quality of Life (HRQL)

  Baseline, 2 months

• Emotional Symptoms

  Baseline, 2 months

• Pain Coping

  Baseline, 2 months

• Self-Efficacy

  Baseline, 2 months

• Social Support

  Baseline, 2 months

Study Arms (2)

Virtual Peer-to-Peer Support Mentoring

EXPERIMENTAL

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).

Behavioral: Virtual Peer-to-Peer Support Mentoring

Waitlist Control

NO INTERVENTION

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).

Interventions

Virtual Peer-to-Peer Support Mentoring BEHAVIORAL

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).

Virtual Peer-to-Peer Support Mentoring

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (3)

• 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.

  PMID: 26808145 RESULT

• 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.

  PMID: 28340203 RESULT

• 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.

  PMID: 27682341 RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer N Stinson, RN,PhD,CPNP

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2016
• Last Updated: January 3, 2018

Record last verified: 2017-12

Locations

CA (1)