Virtual Peer-to-Peer (VP2P) Support Mentoring for Chronic Pain: A Pilot RCT
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|ClinicalTrials.gov Identifier: NCT01986387|
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : January 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: Virtual Peer-to-Peer Support Mentoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Virtual Peer-to-Peer (VP2P) Support Mentoring for Adolescents With Chronic Pain: A Feasibility Pilot Randomized Controlled Trial|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||December 2016|
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).
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: 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).
- Feasibility [ Time Frame: 2 months ]
- 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)
- Health-Related Quality of Life (HRQL) [ Time Frame: Baseline, 2 months ]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 [ Time Frame: Baseline, 2 months ]Anxiety and depression will each be assessed using two, separate 8-item Patient Reported Outcomes Measurement Information System (PROMIS) scales.
- Pain Coping [ Time Frame: Baseline, 2 months ]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 [ Time Frame: Baseline, 2 months ]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 [ Time Frame: Baseline, 2 months ]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 [ Time Frame: Baseline, 2 months ]Disability will be measured using the 15-item Functional Disability Inventory, which assesses physical functioning and disability in youth with chronic pain.
- Self-Management [ Time Frame: Baseline, 2 months ]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 [ Time Frame: Baseline, 2 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986387
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Jennifer N Stinson, RN,PhD,CPNP||The Hospital for Sick Children|