AzTrials
AzTrials

Chronic PainNCT01986387

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

A study testing Virtual Peer-to-Peer Support Mentoring in people with Chronic Pain, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Chronic Pain
What is being tested?
Virtual Peer-to-Peer Support Mentoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
Jul 2013to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Chronic Pain
Being tested
Virtual Peer-to-Peer Support Mentoring
Keywords
adolescent, Skype, peer mentorship, internet self-management
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Peer-to-Peer Support MentoringBehavioural

    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).

Study groups in NCT01986387
Study groupRoleWhat they receive
Virtual Peer-to-Peer Support MentoringExperimentalIn 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).
Receives: Behavioral: Virtual Peer-to-Peer Support Mentoring
Waitlist ControlNo interventionThe 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 2 months

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, 2 months

  2. Emotional Symptoms

    Anxiety and depression will each be assessed using two, separate 8-item Patient Reported Outcomes Measurement Information System (PROMIS) scales.

    Measured: Baseline, 2 months

  3. 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.

    Measured: Baseline, 2 months

  4. 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.

    Measured: Baseline, 2 months

  5. 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.

    Measured: Baseline, 2 months

  6. Disability

    Disability will be measured using the 15-item Functional Disability Inventory, which assesses physical functioning and disability in youth with chronic pain.

    Measured: Baseline, 2 months

  7. 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).

    Measured: Baseline, 2 months

  8. 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.

    Measured: Baseline, 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionMay 2015
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01986387
Sponsor's protocol ID
1000036188
Status last verified
Dec 2017
First submitted
11 Nov 2013
Last updated
3 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26808145

  • 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.

    PubMed 28340203

  • 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.

    PubMed 27682341

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Peer-to-Peer Support Mentoring in people with Chronic Pain, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01986387, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in