Inflammatory Bowel DiseasesNCT03630146
iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease
A study testing iPeer2Peer program in people with Inflammatory Bowel Diseases, run by The Hospital for Sick Children at 4 sites in Canada.
Trial summary
The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD 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
- Inflammatory Bowel Diseases
- What is being tested?
- iPeer2Peer program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesCanada
- Study dates
- 17 May 2018to 16 Mar 2022
- 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,
- gastroenterologist-diagnosed IBD,
- 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 devices),
- willing and able to complete online measures.
Who cannot join
- significant cognitive impairments or
- severe co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment (e.g., psychosis, active suicidal ideation),
- participating in other peer support or self-management interventions
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
The IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD 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
The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD 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).
The proposed trial aims to examine the impact of the iPeer2Peer program on self-management skills of youth with IBD (mentees) as well as health outcomes of peer mentors in the program. This innovative program leverages the Internet, commonly used by youth, to improve access and acceptability of self-management interventions while fostering social engagement in youth with IBD, thereby potentially improving HRQL.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- iPeer2Peer program, Waitlist control
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPeer2Peer programBehavioural
In addition to standard care, youth in the experimental group will receive the iPeer2Peer Program. The iPeer2Peer program is a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with IBD aged 18-25 years) who have learned to function successfully with their disease. Mentors will encourage youth to develop and engage in disease self-management skills and provide social support.
Waitlist controlOther
The control group will receive standard care but without the iPeer2Peer Program.
| Study group | Role | What they receive |
|---|---|---|
| iPeer2Peer Mentorship | Experimental | 10 sessions of 20-30 minute Skype video calls conducted over 5-12 weeks. Receives: Behavioral: iPeer2Peer program |
| Waitlist Control Group | Active comparator | The control group will receive standard care but without the iPeer2Peer program. Receives: Other: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRANSITION-Q (measuring change)
14-item scale that measures self-management skills in health and healthcare in adolescents with chronic health conditions.
Measured: Baseline; up to 12 weeks after baseline; 6 months post program
Secondary outcomes (13)
Disease Activity Survey (measuring change)
21-item survey to measure disease activity and alternative resources therapies used by patients. The scale used in this study is from the Brief Pain Inventory. The scale ranges from 0 to 10 and the higher the value the worse the outcome.
Measured: Baseline; up to 12 weeks after baseline; 6 months post program
IBD Self-efficacy Scale for Adolescents and Young Adults (measuring change)
13-item disease-specific scale to assess SE toward disease management for adolescents and young adults with IBD. Scale scores range from 1 to 5. The higher value represents a better outcome.
Measured: Baseline; up to 12 weeks after baseline; 6 months post program
Brief Resiliency Scale (measuring change)
6-item measure that assesses an individual's ability to bounce back or recover from stress. The total range is a score from 6 to 30. A higher final score represents a better outcome.
Measured: Baseline; up to 12 weeks after baseline; 6 months post program
Revised Child Anxiety and Depression Scale (measuring change)
25-item self-report measure of anxiety and depression characteristics. Measure includes a score for total anxiety, total depression, and total anxiety and depression. The scale ranges from a minimum score of 0 to a maximum score of 3. A higher score represents a worse outcome.
Measured: Baseline; up to 12 weeks after baseline; 6 months post program
PROMIS Pediatric Item Bank v.1.0 - Peer Relationships - Short Form 8a
15-item measure of social health via social function and overall sociability. The scale ranges from value of 0 to 4. The higher the value the better the outcome.
Measured: Baseline; up to 12 weeks after baseline; 6 months post program
IMPACT-III: A Quality of Life Questionnaire for Children with Inflammatory Bowel Disease (measuring change)
35-item quality of life measure specific to pediatric IBD populations. Domain scores include: bowel symptoms, systemic symptoms, emotional functioning, social functioning, body image, and treatment/interventions.
Measured: Baseline; up to 12 weeks after baseline; 6 months post program
Assessment of Quality if Life (AQoL-6D) (measuring change)
20-item self-report measure for six separately scored dimensions and a simple global "utility" score. The scores range from 1 to 5. The higher the score the worse the outcome.
Measured: Baseline; up to 12 weeks after baseline; 6 months post program
Health Services Use and Out-of-Pocket Expense Diary (measuring change)
53-item self-report measure to assess health service use and out of pocket expenses
Measured: Baseline; up to 12 weeks after baseline; 6 months post program
Mentor Behavior Scale (measuring change)
15-item measure of 4 factors that affect mentor quality: structure, engagement, autonomy support, and competency support. The scale ranges in values from 1 to 5. The higher the score the higher the mentor is rated.
Measured: post-intervention (approximately following 12 weeks of calls)
PROMIS Adult Profile v2.0 (measuring change)
For mentors only. 29-item collection of short forms from 7 health domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. The scale is scored from 1 to 5. The higher the score the worse the outcome.
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. 44-item questionnaire that measures satisfaction with one's social functioning (e.g., ability to participate in social roles and activities, and satisfaction with social roles and responsibilities) and social relationships (e.g., companionship, emotional, informational and instrumental support, and social isolation) The scale ranges from scores 1 to 5. The higher the score the better the outcome.
Measured: At beginning of study and at end of study (approximately 3 years later)
Chronic Disease Self-Efficacy scale (measuring change)
For mentors only. 33-item measure with 10 subscales. The scale ranges from scores of 1 to 10. The higher the score the better the outcome.
subscales are conceptually divided into 3 types of self-efficacy: 1). ability to self-management behaviors, 2) ability to manage disease in general, and 3) ability to achieve outcomes.
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 posted14 Aug 2018
- Study start17 May 2018
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahola Kohut, The Hospital for Sick Children
- Investigators
- Sara Ahola Kohut, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630146
- Sponsor's protocol ID
- 1000058684
- Status last verified
- Apr 2023
- First submitted
- 9 Aug 2018
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03630146
- Acronym / sponsor ID
- 1000058684
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 14 Aug 2018 (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 Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD 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
The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD 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).
The proposed trial aims to examine the impact of the iPeer2Peer program on self-management skills of youth with IBD (mentees) as well as health outcomes of peer mentors in the program. This innovative program leverages the Internet, commonly used by youth, to improve access and acceptability of self-management interventions while fostering social engagement in youth with IBD, thereby potentially improving HRQL.
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 program10 sessions of 20-30 minute Skype video calls conducted over 5-12 weeks. |
| Waitlist Control Group | Active comparator | Other: Waitlist controlThe 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,
- gastroenterologist-diagnosed IBD,
- 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 devices),
- willing and able to complete online measures.
Key exclusion criteria (3 listed)
- significant cognitive impairments or
- severe co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment (e.g., psychosis, active suicidal ideation),
- 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 programIn addition to standard care, youth in the experimental group will receive the iPeer2Peer Program. The iPeer2Peer program is a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with IBD aged 18-25 years) who have learned to function successfully with their disease. Mentors will encourage youth to develop and engage in disease self-management skills and provide social support. | Behavioural | iPeer2Peer Mentorship |
| Waitlist controlThe control group will receive standard care but without the iPeer2Peer Program. | Other | Waitlist Control Group |
Primary outcome
TRANSITION-Q (measuring change)
Time frame: Baseline; up to 12 weeks after baseline; 6 months post program
14-item scale that measures self-management skills in health and healthcare in adolescents with chronic health conditions.
13 secondary outcomes
Disease Activity Survey (measuring change)
Time frame: Baseline; up to 12 weeks after baseline; 6 months post program
IBD Self-efficacy Scale for Adolescents and Young Adults (measuring change)
Time frame: Baseline; up to 12 weeks after baseline; 6 months post program
Brief Resiliency Scale (measuring change)
Time frame: Baseline; up to 12 weeks after baseline; 6 months post program
Revised Child Anxiety and Depression Scale (measuring change)
Time frame: Baseline; up to 12 weeks after baseline; 6 months post program
PROMIS Pediatric Item Bank v.1.0 - Peer Relationships - Short Form 8a
Time frame: Baseline; up to 12 weeks after baseline; 6 months post program
IMPACT-III: A Quality of Life Questionnaire for Children with Inflammatory Bowel Disease (measuring change)
Time frame: Baseline; up to 12 weeks after baseline; 6 months post program
Assessment of Quality if Life (AQoL-6D) (measuring change)
Time frame: Baseline; up to 12 weeks after baseline; 6 months post program
Health Services Use and Out-of-Pocket Expense Diary (measuring change)
Time frame: Baseline; up to 12 weeks after baseline; 6 months post program
Mentor Behavior Scale (measuring change)
Time frame: post-intervention (approximately following 12 weeks of calls)
PROMIS Adult Profile v2.0 (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 12 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Sara Ahola Kohut, PhD principal investigator
The Hospital for Sick Children
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPeer2Peer program in people with Inflammatory Bowel Diseases, run by The Hospital for Sick Children at 4 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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; up to 12 weeks after baseline; 6 months post program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2023.