Heart FailureiP2P HFNCT05709132
iP2P Mentorship Program for Adolescent HF Patients
A study testing iPeer2Peer Program in people with Heart Failure, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The iPeer2Peer (iP2P) program is an online peer support mentorship program that provides modelling and reinforcement by trained young adult peer mentors to adolescent mentees with the same condition. A quasi-experimental single-arm pre-post study design will be employed across three sites. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Heart Failure
- 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
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2024to 13 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- significant cognitive impairments as assessed by a qualified healthcare provider,
- a diagnosis of an active psychological disorder (e.g., Major Depressive Disorder, Generalized Anxiety Disorder) likely to influence assessment of health-related quality of life and/or interfere with their ability to manage their heart failure care regimen (a diagnosis of an active psychological disorder will be determined for mentees through medical chart review and self-reported by mentors), and
- participating in other peer support or self-management interventions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sophie Bui, BHSc contact
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Samantha J Anthony, PhD, 416-813-7654 ext. 303126, samantha.anthony@sickkids.ca
Samantha J Anthony, PhD
About this study
Official title: Implementation and Preliminary Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program for Adolescent and Transitioning Heart Function Patients
The iPeer2Peer (iP2P) program is an online peer support mentorship program that provides modelling and reinforcement by trained young adult peer mentors to adolescent mentees with the same condition. A quasi-experimental single-arm pre-post study design will be employed across three sites. We will recruit 40 mentees (12-17 years of age) and 12-15 mentors (18-30 years of age) who will undergo training in mentoring and the use of eHealth technology. Mentor-mentee pairings will connect over 15 weeks through video calls and text messaging to provide peer support and encourage disease self-management skills. Data will be collected using standardized instruments and interviews across three time points.
- Conditions
- Heart Failure
- Being tested
- iPeer2Peer Program
- Keywords
- Peer Support Mentorship, Pediatrics, Adherence, Cardiomyopathy
- Medical subject headings
- Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPeer2Peer ProgramBehavioural
Behavioral: iPeer2Peer Support Mentorship Program is an online peer support mentorship program that has been established in multiple chronic disease populations as a self-management intervention, including chronic pain and juvenile idiopathic arthritis. The iPeer2Peer program provides modeling and reinforcement by pre-screened and trained young adult peer mentors to adolescent mentees.
| Study group | Role | What they receive |
|---|---|---|
| iPeer2Peer Program | Experimental | Participates in the iPeer2Peer program Receives: Behavioral: iPeer2Peer Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability (Mentees)
Whether the innovation is agreeable, palatable or satisfactory
Measured: 15 weeks after baseline/immediately after the intervention
Acceptability (Mentors)
Whether the innovation is agreeable, palatable or satisfactory
Measured: Study completion, an average of 1 year
Adoption (Mentees)
The intention, initial decision or action to try or use an innovation
Measured: Baseline to 12 weeks post-program completion
Adoption (Mentors)
The intention, initial decision or action to try or use an innovation
Measured: Baseline to study completion, an average of 1 year
Feasibility (Mentees)
The extent to which an innovation can be used or carried out successfully in a given setting
Measured: Baseline to 12 weeks post-program completion
Feasibility (Mentors)
The extent to which an innovation can be used or carried out successfully in a given setting
Measured: Baseline to study completion, an average of 1 year
Appropriateness (Mentees)
The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem
Measured: Baseline to 12 weeks post-program completion
Appropriateness (Mentors)
The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem
Measured: Baseline to study completion, an average of 1 year
Level of engagement (Mentees)
Measured: 15 weeks after baseline/immediately after the intervention
Level of engagement (Mentors)
Measured: Study completion, an average of 1 year
Secondary outcomes (10)
Disease self-management skills (Mentees)
Measured: Baseline to 12 weeks post-program completion
Adherence (Mentees)
Clinic attendance, completion of scheduled tests and procedures, and adolescent medication barriers scale
Measured: Baseline to 12 weeks post-program completion
Quality of life (Mentees)
Measured: Baseline to 12 weeks post-program completion
Perceived social support (Mentees)
Measured: Baseline to 12 weeks post-program completion
Emotional distress (Mentees)
Measured: Baseline to 12 weeks post-program completion
Resiliency (Mentees)
Measured: Baseline to 12 weeks post-program completion
Assessment of mentor quality (Mentees)
Measured: 15 weeks after baseline/immediately after the intervention
Physical and emotional symptoms (Mentors)
Measured: Baseline to study completion, an average of 1 year
Perceived social role satisfaction (Mentors)
Measured: Baseline to study completion, an average of 1 year
Self-efficacy (Mentors)
Measured: Baseline to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Jan 2024
- Primary completion13 Apr 2027 (estimated)
- Study completion13 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental single arm pre-post study
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Centre Hospitalier Universitaire Sainte-Justine, University of Alberta/Stollery Children's Hospital
- Responsible party
- Principal investigator, Samantha Anthony, The Hospital for Sick Children
- Investigators
- Samantha J Anthony, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709132
- Sponsor's protocol ID
- 1000080204
- Acronym
- iP2P HF
- Status last verified
- Jul 2025
- First submitted
- 24 Jan 2023
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Preliminary Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program for Adolescent and Transitioning Heart Function Patients
- ClinicalTrials.gov ID
- NCT05709132
- Acronym / sponsor ID
- iP2P HF / 1000080204
- Conditions
- Heart Failure
- Keywords
- Peer Support Mentorship, Pediatrics, Adherence, Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Centre Hospitalier Universitaire Sainte-Justine, University of Alberta/Stollery Children's Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 13 Apr 2027 (estimated)
- Study completion
- 13 Apr 2027 (estimated)
- First posted
- 1 Feb 2023 (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 (iP2P) program is an online peer support mentorship program that provides modelling and reinforcement by trained young adult peer mentors to adolescent mentees with the same condition. A quasi-experimental single-arm pre-post study design will be employed across three sites. We will recruit 40 mentees (12-17 years of age) and 12-15 mentors (18-30 years of age) who will undergo training in mentoring and the use of eHealth technology. Mentor-mentee pairings will connect over 15 weeks through video calls and text messaging to provide peer support and encourage disease self-management skills. Data will be collected using standardized instruments and interviews across three time points.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental single arm pre-post study
| Arm | Type | Receives |
|---|---|---|
| iPeer2Peer Program | Experimental | Behavioral: iPeer2Peer ProgramParticipates in the iPeer2Peer program |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- significant cognitive impairments as assessed by a qualified healthcare provider,
- a diagnosis of an active psychological disorder (e.g., Major Depressive Disorder, Generalized Anxiety Disorder) likely to influence assessment of health-related quality of life and/or interfere with their ability to manage their heart failure care regimen (a diagnosis of an active psychological disorder will be determined for mentees through medical chart review and self-reported by mentors), and
- 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 ProgramBehavioral: iPeer2Peer Support Mentorship Program is an online peer support mentorship program that has been established in multiple chronic disease populations as a self-management intervention, including chronic pain and juvenile idiopathic arthritis. The iPeer2Peer program provides modeling and reinforcement by pre-screened and trained young adult peer mentors to adolescent mentees. | Behavioural | iPeer2Peer Program |
Primary outcome
Acceptability (Mentees)
Time frame: 15 weeks after baseline/immediately after the intervention
Whether the innovation is agreeable, palatable or satisfactory
Acceptability (Mentors)
Time frame: Study completion, an average of 1 year
Whether the innovation is agreeable, palatable or satisfactory
Adoption (Mentees)
Time frame: Baseline to 12 weeks post-program completion
The intention, initial decision or action to try or use an innovation
Adoption (Mentors)
Time frame: Baseline to study completion, an average of 1 year
The intention, initial decision or action to try or use an innovation
Feasibility (Mentees)
Time frame: Baseline to 12 weeks post-program completion
The extent to which an innovation can be used or carried out successfully in a given setting
Feasibility (Mentors)
Time frame: Baseline to study completion, an average of 1 year
The extent to which an innovation can be used or carried out successfully in a given setting
Appropriateness (Mentees)
Time frame: Baseline to 12 weeks post-program completion
The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem
Appropriateness (Mentors)
Time frame: Baseline to study completion, an average of 1 year
The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem
Level of engagement (Mentees)
Time frame: 15 weeks after baseline/immediately after the intervention
Level of engagement (Mentors)
Time frame: Study completion, an average of 1 year
10 secondary outcomes
Disease self-management skills (Mentees)
Time frame: Baseline to 12 weeks post-program completion
Adherence (Mentees)
Time frame: Baseline to 12 weeks post-program completion
Quality of life (Mentees)
Time frame: Baseline to 12 weeks post-program completion
Perceived social support (Mentees)
Time frame: Baseline to 12 weeks post-program completion
Emotional distress (Mentees)
Time frame: Baseline to 12 weeks post-program completion
Resiliency (Mentees)
Time frame: Baseline to 12 weeks post-program completion
Assessment of mentor quality (Mentees)
Time frame: 15 weeks after baseline/immediately after the intervention
Physical and emotional symptoms (Mentors)
Time frame: Baseline to study completion, an average of 1 year
Perceived social role satisfaction (Mentors)
Time frame: Baseline to study completion, an average of 1 year
Self-efficacy (Mentors)
Time frame: Baseline to study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- 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.
Sophie Bui, BHSc contact
Samantha J Anthony, PhD principal investigator
The Hospital for Sick Children
1 site 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 Heart Failure, 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 0 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: looking for participants now, as of the sponsor's last update on 9 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha J Anthony, PhD (416-813-7654 ext. 303126, samantha.anthony@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (Mentees) (time frame: 15 weeks after baseline/immediately after the intervention). The study lists 10 primary outcomes in all. 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 9 Jul 2025.