Juvenile Idiopathic ArthritisiPeer2PeerNCT03116763
The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis
A study testing iPeer2Peer Mentorship in people with Juvenile Idiopathic Arthritis, run by The Hospital for Sick Children at 6 sites in Canada.
Trial summary
The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- iPeer2Peer Mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 6 sitesCanada
- Study dates
- 28 Mar 2017to 16 Apr 2023
- 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
- rheumatologist-diagnosed JIA according to ILAR criteria
- able to speak and read English
- access to a computer, smartphone or tablet capable of using free Skype software (note: participants who do not have adequate Internet access will be provided with portable Internet sticks)
- willing and able to complete online measures.
Who cannot join
- significant cognitive impairments
- major co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment
- participating in other peer support or self-management interventions.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
The IWK Health Centre
Halifax, Nova Scotia
Children's Hospital - London Health Sciences
London, Ontario, N6A 5W9
Children's Hospital of Eastern Ontario (CHEO)
Ottawa, Ontario
The Hospital for Sick Children
Toronto, Ontario
BC Children's Hospital
Vancouver, British Columbia
About this study
Official title: The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor).
Read the detailed description
Arthritis is a common childhood illness that makes everyday activities hard for young people. It is a long-lasting illness that can make you feel pain, tired and emotionally upset. This can make it hard for children and teens to see friends and do the activities that they like. The goal of this project is to find out if the newly developed peer mentoring program called iPeer2Peer helps teens with arthritis take better care of their illness and feel more connected to other people with arthritis. The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor).
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- iPeer2Peer Mentorship, Active Comparator: Control Group
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPeer2Peer MentorshipBehavioural
10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.
Active Comparator: Control GroupOther
The control group will receive standard care but without the iPeer2Peer program.
| Study group | Role | What they receive |
|---|---|---|
| iPeer2Peer Mentorship | Experimental | In addition to standard care, youth in the experimental group will receive the iPeer2Peer program, a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with JIA aged 18-22 years who have learned to function successfully with their disease). Mentors will encourage participants to develop and engage in self-management skills and provide social support. Receives: Behavioral: iPeer2Peer Mentorship |
| Control Group | Active comparator | The control group will receive standard care but without the iPeer2Peer program. Receives: Other: Active Comparator: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRANSITION-Q (measuring change)
14-item measure of self-management skills that is both reliable (internally consistent, test-retest) and valid (face, construct and content validity)
Measured: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary outcomes (14)
PedsQL Arthritis Module (measuring change)
Health-related quality of life
Measured: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
PROMIS Pain Interference (measuring change)
Pain
Measured: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Screen for Child Anxiety Related Disorders (measuring change)
Emotional distress
Measured: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Center for Epidemiologic Studies Depression Scale Revised (measuring change)
Emotional distress
Measured: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)
Disease knowledge
Measured: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Children's Arthritis Self-Efficacy (measuring change)
Self-efficacy
Measured: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
PROMIS Pediatric Peer Relationship Scale (measuring change)
Perceived social support
Measured: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
AQoL-6D, interview (measuring change)
Cost utility analysis
Measured: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Health service use and costs (measuring change)
Cost utility analysis
Measured: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Mentor Behavior Scale (measuring change)
Mentor quality
Measured: Post-Intervention (approximately following 12 weeks of calls)
PROMIS Adult Profile (measuring change)
For mentors only: mentor physical and emotional symptoms
Measured: At beginning of study and at end of study (approximately 3 years later)
PROMIS Satisfaction with Social Roles and Activities (measuring change)
For mentors only: perceived social role satisfaction
Measured: At beginning of study and at end of study (approximately 3 years later)
Chronic Disease Self-Efficacy Scale (measuring change)
For mentors only: self-efficacy
Measured: At beginning of study and at end of study (approximately 3 years later)
Mentor interaction form
Record of interactions with mentees
Measured: Following completion of each mentee's calls (approximately following 12 weeks of calls)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start28 Mar 2017
- Primary completion16 Apr 2023
- Study completion16 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, IWK Health Centre, Children's Hospital of Eastern Ontario
- Responsible party
- Principal investigator, Jennifer Stinson, The Hospital for Sick Children
- Investigators
- Jennifer N Stinson, CPNP, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116763
- Sponsor's protocol ID
- 1000054878
- Acronym
- iPeer2Peer
- Status last verified
- Nov 2023
- First submitted
- 31 Mar 2017
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nishat F, Kelenc L, Berard R, Duffy C, Feldman B, Forgeron P, Huber AM, Luca N, Schmeling H, Spiegel L, Tucker L, Watanabe-Duffy K, Killackey T, Lalloo C, Wiles B, Nair A, Olaizola S, McDermott B, Tavangar F, Kohut SA, Stinson JN. Assessing the impact of the iPeer2Peer program for adolescents with juvenile idiopathic arthritis: a mixed-methods randomized controlled trial. Pediatr Rheumatol Online J. 2024 Dec 27;22(1):109. doi: 10.1186/s12969-024-01052-5.
PubMed 39731098
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03116763
- Acronym / sponsor ID
- iPeer2Peer / 1000054878
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, IWK Health Centre, Children's Hospital of Eastern Ontario
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 16 Apr 2023 (actual)
- Study completion
- 16 Apr 2023 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor).
Detailed description
Arthritis is a common childhood illness that makes everyday activities hard for young people. It is a long-lasting illness that can make you feel pain, tired and emotionally upset. This can make it hard for children and teens to see friends and do the activities that they like. The goal of this project is to find out if the newly developed peer mentoring program called iPeer2Peer helps teens with arthritis take better care of their illness and feel more connected to other people with arthritis. The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iPeer2Peer Mentorship | Experimental | Behavioral: iPeer2Peer MentorshipIn addition to standard care, youth in the experimental group will receive the iPeer2Peer program, a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with JIA aged 18-22 years who have learned to function successfully with their disease). Mentors will encourage participants to develop and engage in self-management skills and provide social support. |
| Control Group | Active comparator | Other: Active Comparator: Control GroupThe control group will receive standard care but without the iPeer2Peer program. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- males and females 12-18 years old
- rheumatologist-diagnosed JIA according to ILAR criteria
- able to speak and read English
- access to a computer, smartphone or tablet capable of using free Skype software (note: participants who do not have adequate Internet access will be provided with portable Internet sticks)
- willing and able to complete online measures.
Key exclusion criteria (3 listed)
- significant cognitive impairments
- major co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment
- participating in other peer support or self-management interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPeer2Peer Mentorship10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks. | Behavioural | iPeer2Peer Mentorship |
| Active Comparator: Control GroupThe control group will receive standard care but without the iPeer2Peer program. | Other | Control Group |
Primary outcome
TRANSITION-Q (measuring change)
Time frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
14-item measure of self-management skills that is both reliable (internally consistent, test-retest) and valid (face, construct and content validity)
14 secondary outcomes
PedsQL Arthritis Module (measuring change)
Time frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
PROMIS Pain Interference (measuring change)
Time frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Screen for Child Anxiety Related Disorders (measuring change)
Time frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Center for Epidemiologic Studies Depression Scale Revised (measuring change)
Time frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)
Time frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Children's Arthritis Self-Efficacy (measuring change)
Time frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
PROMIS Pediatric Peer Relationship Scale (measuring change)
Time frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
AQoL-6D, interview (measuring change)
Time frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Health service use and costs (measuring change)
Time frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Mentor Behavior Scale (measuring change)
Time frame: Post-Intervention (approximately following 12 weeks of calls)
PROMIS Adult Profile (measuring change)
Time frame: At beginning of study and at end of study (approximately 3 years later)
PROMIS Satisfaction with Social Roles and Activities (measuring change)
Time frame: At beginning of study and at end of study (approximately 3 years later)
Chronic Disease Self-Efficacy Scale (measuring change)
Time frame: At beginning of study and at end of study (approximately 3 years later)
Mentor interaction form
Time frame: Following completion of each mentee's calls (approximately following 12 weeks of calls)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 39731098Nishat F, Kelenc L, Berard R, Duffy C, Feldman B, Forgeron P, Huber AM, Luca N, Schmeling H, Spiegel L, Tucker L, Watanabe-Duffy K, Killackey T, Lalloo C, Wiles B, Nair A, Olaizola S, McDermott B, Tavangar F, Kohut SA, Stinson JN. Assessing the impact of the iPeer2Peer program for adolescents with juvenile idiopathic arthritis: a mixed-methods randomized controlled trial. Pediatr Rheumatol Online J. 2024 Dec 27;22(1):109. doi: 10.1186/s12969-024-01052-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer N Stinson, CPNP, PhD principal investigator
The Hospital for Sick Children
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPeer2Peer Mentorship in people with Juvenile Idiopathic Arthritis, run by The Hospital for Sick Children at 6 sites 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 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
TRANSITION-Q (measuring change) (time frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post). 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 NCT03116763, which also lists 1 linked publication.
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 24 Nov 2023.