Congenital Heart Disease (CHD)NCT07898384
Optimizing Care Transitions in CHD
A study testing Peer mentorship in people with Congenital Heart Disease (CHD) and Mentorship, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Adolescents and young adults (AYA) with congenital heart disease (CHD) face psychosocial stresses as they transition to adult care. Parents of AYA with CHD also experience increased caregiver burden and psychosocial stresses. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Congenital Heart Disease (CHD), Mentorship, Transition of Care
- What is being tested?
- Peer mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Dec 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- AYA with CHD
- diagnosed with moderate to severe CHD with an expected 5-year survival rate of more than 70% according to the treating cardiologist or a qualified healthcare professional,
- 16-25 years old with the capacity to give consent,
- able to speak and read English,
- willingness to commit to 5-10 texts and/or calls of 20-30 minutes each with a peer mentor over a period of 12 weeks,
- access to a device (e.g., smartphone, tablet, computer) capable of using free WhatsApp software.
Show all 16Show fewer
- Parents of AYA with CHD
- parent of an AYA between the ages of 16 and 25 with moderate to severe CHD with an expected 5-year survival rate of more than 70% according to the treating cardiologist or a qualified healthcare professional currently followed by SickKids,
- access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software,
- able to speak and read English, and (4) willingness to commit to 5-10 texts and/or calls of 20-30 minutes each with a parent mentor over a period of 12 weeks.
- Young adult mentors (1)21-30 year old with CHD (2) nominated by a member of their healthcare team as a good candidate to act in the mentor role based on maturity and emotional stability (e.g., good communication skills, positive adaptation and adjustment, strong support network), (3) willingness to commit to virtual peer mentor training, (4) able to speak and read English, (5) access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software.
- Parent mentors
- parents of AYA with CHD between the ages of 21-30 year old
- willingness to commit to virtual peer mentor training,
- able to speak and read English,
- access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software.
Who cannot join
- AYA mentees will be excluded if they: (1) have significant cognitive impairments as assessed by a qualified healthcare provider, or (2) have a diagnosis of an active psychological disorder (e.g., Major Depressive Disorder) likely to interfere with their ability to manage their care as determined by a qualified healthcare provider, or (3) received surgery for a CHD diagnosis in the last 6 months, or (4) have undergone a heart transplant, or (5) are participating in current peer support programs, or (6) are receiving end-of-life care.
- Parent mentees will be excluded if
- they have significant cognitive impairments as assessed by a qualified healthcare provider, or
- they have a diagnosis of an active psychological disorder (e.g., Major Depressive Disorder) likely to interfere with their ability to manage their child's care as determined by a qualified healthcare provider, or
- their child received surgery for a CHD diagnosis in the last 6 months, or
- their child has undergone a heart transplant, or
Show all 12Show fewer
- they are participating in current peer support programs, or
- their child is receiving end-of-life care.
- Young adult and parent mentors
- Significant cognitive impairments as assessed by a qualified healthcare provider, or
- have a diagnosis of an active psychological disorder (e.g.: Major Depressive Disorder, etc.; determined through chart review by a qualified HCP) likely to influence assessment of health-related quality of life and/or interfere with their ability to manage their own care, or
- are 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.
Canada1 site
The Hospital for Sick Children
Toronto, Ontario
Samantha Anthony, 416-813-7654 ext. 303126, samantha.anthony@sickkids.ca
Samantha Anthony
About this study
Official title: Optimizing Care Transitions in Congenital Heart Disease: Pediatric to Adult Transition
Adolescents and young adults (AYA) with congenital heart disease (CHD) face psychosocial stresses as they transition to adult care. Parents of AYA with CHD also experience increased caregiver burden and psychosocial stresses. Peer support provided by a person with a similar experience has been found to improve disease self-management and psychosocial health outcomes in pediatric healthcare. However, many AYA with CHD still do not have access to formal social support resources. The aim of this study is to improve pediatric to adult transitions in healthcare by evaluating peer mentorship programs for AYA with CHD and their parents.
Established, online mentorship programs, iPeer2Peer(iP2P)/iParent2Parent, will be employed through a pilot feasibility waitlist randomized controlled trial with repeated measures across four sites. Eighty mentees (AYA and parents of AYA) will be recruited and randomized into intervention and control groups. Forty mentees in the intervention group will be matched 1:1 with 30 trained mentors (young adults and parents of AYA). AYA mentees will be matched with young adult mentors and parents of AYA will be matched with other parent mentors. These pairings will connect over 12 weeks through video calls and text messaging to provide peer support to improve self-management and psychosocial health outcomes.
Read the detailed description
Primary Objective: to evaluate the feasibility of virtual intervention programs (iP2P and iParent2Parent) for AYA with CHD and their parents as both mentors and mentees in terms of: (a) enrollment and withdrawal rates (b) adherence with the programs (c) perceptions regarding the acceptability and level of engagement in the programs of both mentees and mentors, and (d) perceptions of barriers and enablers of the programs. Secondary Objective: to explore these programs impact on preliminary psychosocial outcomes. Specifically,
- Impact of the iP2P program on: (a) transition readiness including self-management skills, (b) perceived social support, and (c) emotional distress, in AYA mentees. (a) perceived social role satisfaction and (b) emotional distress, in young adult mentors.
- Impact of the iParent2Parent program on:
- perceived social support, (b) emotional distress, and (c) coping, in parent mentees. <!-- -->
- perceived social role satisfaction, and (b) emotional distress, in parent mentors.
A waitlist pilot RCT allows for an effective comparison of the study intervention with a control group receiving standard of care while not disadvantaging the control group who will have the option of participating in the intervention following the completion of the trial. This design therefore ensures that a potentially useful and effective intervention is accessible to all participants.
Up to 110 participants will be enrolled in the study from CHD programs in Toronto (SickKids/Toronto General Hospital), Edmonton (Stollery Children's Hospital/Mazankowski Alberta Heart Institute), Vancouver (BC Children's Hospital/St. Paul's Hospital), andMontreal (Ste. Justine/Montreal Heart Institute).
Up to 40 AYA (ages 16-25) and 40 parent mentees will be enrolled across the CHD programs, with about 10 AYA and about 10parent mentees per city.
Up to 15 young adults (ages 21-30) and 15 parent mentors will be enrolled across the adult sites of these CHD programs(Toronto General Hospital, Mazankowski Alberta Heart Institute, St. Paul's Hospital, and Montreal Heart Institute). The investigators anticipate 3-4 young adult mentors, and 3-4 parent mentors will be enrolled per site.
All mentees (40 mentees) will be asked to participate in semi-structured individual interviews at baseline (ME T1) and and all mentees in the intervention group (20 mentees) will be asked to participate in semi-structured interviews at 12 weeks - immediately post-intervention (ME T2). Interviews will be conducted by an interviewer trained in qualitative methods by telephone, in-person or virtually via the PHIPA-compliant version of Zoom or Microsoft Teams (depending on participants' preference), at a time that is convenient for the participant. Interviews will be guided by a semi-structured interview guide. ME T1 interviews will aim to assess motivations for participation, hopes and expectations, and preferences around mentor characteristics; and ME T2 interviews will aim to assess the primary outcomes evaluating feasibility.
All mentors (30 mentors) will be asked to participate in a focus group/semi-structured interview prior to mentor training (MR T1) and study end (MR T2). MR T1 focus groups/interviews will aim to assess motivations for participation and hopes and expectations, and MR T2 focus groups/interviews will aim to assess the primary outcomes evaluating feasibility. Focus groups/interviews will be conducted by an interviewer trained in qualitative methods. Focus groups/interviews will be conducted on a mutually agreed upon date and over the internet via a web-based video communication program (e.g., PHIPA-compliant version of Zoom or Microsoft Teams).
The semi-structured individual interviews and focus groups will be audiotaped, transcribed and analyzed using qualitative descriptive approach using thematic and content analysis.
- Conditions
- Congenital Heart Disease (CHD), Mentorship, Transition of Care, Peer Support, Peer Support and Chronic Disease, Adolescent
- Being tested
- Peer mentorship
- Keywords
- congenital heart disease, mentorship, peer support, care transition, adolescent and young adult, parent
- Medical subject headings
- Heart Defects, Congenital, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer mentorshipBehavioural
Also called Peer mentoring, Peer support
The iPeer2Peer/iParent2Parent intervention is a peer support mentorship program that will provide modelling and reinforcement by pre-screened and trained peer mentors to the mentees. The mentorship program will encourage mentees to develop and engage in self-management and transition skills and support the participants; practice of these skills. The mentors will provide information and support to mentee participants via 5-10 calls (using WhatsApp) of 20-30 minute durations and text messaging (using WhatsApp) for 12 weeks to encourage participation in self-management skill building tailored to their needs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In addition to their standard medical care, mentees in the experimental group will receive mentorship and support via the iP2P/iParent2Parent program. Trained mentors will provide information and support to mentee participants to encourage participation in self-management skill-building tailored to their needs. Each mentor will work with no more than two mentees at once for the study. Efforts will be made to pair mentors and mentees who share similar characteristics (e.g., similar disease severity, symptom profile, treatment regimen experiences, caregiver role, sex/gender, geographic area of residence). To ensure safety, a member of the research team will monitor all calls and messaging conversations as well as intervene in any potential safety concerns (e.g., discussion of suicidal ideation) or inappropriate behavior (e.g. bullying). Receives: Behavioral: Peer mentorship |
| Waitlist control group | No intervention | The control group will receive standard care without the iP2P/iParent2Parent intervention. The control group will be offered the iP2P/iParent2Parent intervention after completion of all outcome measures for a period of 12 weeks with the same research team support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and withdrawal rates
Recruitment rates (more than 70%) and withdrawal rates (less than 15%) as calculated using data recorded in participant recruitment log.
Measured: 12 weeks
Adherence
Adherence with iP2P/iParent2Parent program (more than 80% rate of completion of at least five audio or video calls over 12 weeks and 100% rate of completion of all online outcome measures) as calculated using data recorded in participant program tracking log.
Measured: 12 weeks
Acceptability/Level of engagement
Acceptability and level of engagement of the iP2P/iParent2Parent program intervention as measured through focus groups/interviews with mentors and interviews with mentees guided by the Theoretical Framework of Acceptability. Focus groups and interviews will take approximately 45 minutes per timepoint.
Measured: 12 weeks
Barriers/Enablers
Barriers and enablers of the iP2P/iParent2Parent program intervention as measured through focus groups/interviews with mentors and interviews with mentees.
Measured: 12 weeks
Secondary outcomes (18)
Perceived social role satisfaction (young adult mentor outcome)
Perceived social role satisfaction measured by the PROMIS Satisfaction with Social Roles and Activities.
Minimum value: 0 Maximum value: 100 Higher score indicates better outcome
Measured: 12 weeks
Emotional distress (young adult mentor outcome)
Emotional distress measured by the Generalized Anxiety Disorder-7 (GAD-7). Minimum value: 0 Maximum value: 21 Higher score indicates worse outcome
Measured: 12 weeks
Emotional distress (young adult mentor outcome)
Emotional distress measured by the Patient Health Questionnaire-8 (PHQ-8). Minimum value: 0 Maximum value: 24 Higher score indicates worse outcome
Measured: 12 weeks
Perceived social role satisfaction (parent mentor outcome)
Perceived social role satisfaction measured by the PROMIS Satisfaction with Social Roles and Activities.
Minimum value: 0 Maximum value: 100 Higher score indicates better outcome
Measured: 12 weeks
Emotional distress (parent mentor outcome)
Emotional distress measured by the Generalized Anxiety Disorder-7 (GAD-7). Minimum value: 0 Maximum value: 21 Higher score indicates worse outcome
Measured: 12 weeks
Emotional distress (parent mentor outcome)
Emotional distress measured by the Patient Health Questionnaire-8 (PHQ-8). Minimum value: 0 Maximum value: 24 Higher score indicates worse outcome
Measured: 12 weeks
Emotional distress (parent mentor outcome)
Emotional distress measured by the Parental Stress Scale (PSS). Minimum value: 18 Maximum value: 90 Higher score indicates worse outcome
Measured: 12 weeks
Transition readiness (adolescent/young adult mentee outcome)
Transition readiness measured by the Transition Readiness Assessment Questionnaire (TRAQ).
Minimum value: 20 Maximum value: 100 Higher score indicates better outcome
Measured: 12 and 24 weeks
Perceived social support (adolescent/young adult mentee outcome)
Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS).
Minimum value: 12 Maximum value: 84 Higher score indicates better outcome
Measured: 12 and 24 weeks
Emotional distress (adolescent/young adult mentee outcome)
Emotional distress measured by the Generalized Anxiety Disorder-7 (GAD-7). Minimum value: 0 Maximum value: 21 Higher score indicates worse outcome
Measured: 12 and 24 weeks
Emotional distress (adolescent/young adult mentee outcome)
Emotional distress measured by the Patient Health Questionnaire-8 (PHQ-8). Minimum value: 0 Maximum value: 24 Higher score indicates worse outcome
Measured: 12 and 24 weeks
Mentor quality (adolescent/young adult mentee outcome)
Mentor quality measured by the Mentor Behaviour Scale. Minimum value: 15 Maximum value: 75 Higher score indicates better outcome
Measured: 12 and 24 weeks
Emotional distress (parent mentee outcome)
Emotional distress measured by the Generalized Anxiety Disorder-7 (GAD-7). Minimum value: 0 Maximum value: 21 Higher score indicates worse outcome
Measured: 12 and 24 weeks
Emotional distress (parent mentee outcome)
Emotional distress measured by the Patient Health Questionnaire-8 (PHQ-8). Minimum value: 0 Maximum value: 24 Higher score indicates worse outcome
Measured: 12 and 24 weeks
Emotional distress (parent mentee outcome)
Emotional distress measured by the Parental Stress Scale (PSS). Minimum value: 18 Maximum value: 90 Higher score indicates worse outcome
Measured: 12 and 24 weeks
Coping (parent mentee outcome)
Coping as measured by the Coping Health Inventory for Parents (CHIP-16). Minimum value: 0 Maximum value: 48 Higher score indicates better outcome
Measured: 12 and 24 weeks
Mentor quality (parent mentee outcome)
Mentor quality measured by the Mentor Behaviour Scale. Minimum value: 15 Maximum value: 75 Higher score indicates better outcome
Measured: 12 and 24 weeks
Perceived social support (parent mentee outcome)
Perceived social support measured by Multidimensional Scale Of Perceived Social Support (MSPSS).
Minimum value: 12 Maximum value: 84 Higher score indicates better outcome
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot feasibility waitlist randomized controlled trial (RCT) design with repeated measures, and following CONSORT guidelines, will be used to evaluate the iP2P and iParent2Parent programs in AYA with CHD and their parents. A waitlist pilot RCT allows for an effective comparison of the study intervention with a control group receiving standard of care while not disadvantaging the control group who will have the option of participating in the intervention following the completion of the trial. This design therefore ensures that a potentially useful and effective intervention is accessible to all participants.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Samantha Anthony, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898384
- Sponsor's protocol ID
- 1000081856
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2026
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care Transitions in Congenital Heart Disease: Pediatric to Adult Transition
- ClinicalTrials.gov ID
- NCT07898384
- Acronym / sponsor ID
- 1000081856
- Conditions
- Congenital Heart Disease (CHD), Mentorship, Transition of Care, Peer Support, Peer Support and Chronic Disease, Adolescent
- Keywords
- congenital heart disease, mentorship, peer support, care transition, adolescent and young adult, parent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
Adolescents and young adults (AYA) with congenital heart disease (CHD) face psychosocial stresses as they transition to adult care. Parents of AYA with CHD also experience increased caregiver burden and psychosocial stresses. Peer support provided by a person with a similar experience has been found to improve disease self-management and psychosocial health outcomes in pediatric healthcare. However, many AYA with CHD still do not have access to formal social support resources. The aim of this study is to improve pediatric to adult transitions in healthcare by evaluating peer mentorship programs for AYA with CHD and their parents.
Established, online mentorship programs, iPeer2Peer(iP2P)/iParent2Parent, will be employed through a pilot feasibility waitlist randomized controlled trial with repeated measures across four sites. Eighty mentees (AYA and parents of AYA) will be recruited and randomized into intervention and control groups. Forty mentees in the intervention group will be matched 1:1 with 30 trained mentors (young adults and parents of AYA). AYA mentees will be matched with young adult mentors and parents of AYA will be matched with other parent mentors. These pairings will connect over 12 weeks through video calls and text messaging to provide peer support to improve self-management and psychosocial health outcomes.
Detailed description
Primary Objective: to evaluate the feasibility of virtual intervention programs (iP2P and iParent2Parent) for AYA with CHD and their parents as both mentors and mentees in terms of: (a) enrollment and withdrawal rates (b) adherence with the programs (c) perceptions regarding the acceptability and level of engagement in the programs of both mentees and mentors, and (d) perceptions of barriers and enablers of the programs. Secondary Objective: to explore these programs impact on preliminary psychosocial outcomes. Specifically,
- Impact of the iP2P program on: (a) transition readiness including self-management skills, (b) perceived social support, and (c) emotional distress, in AYA mentees. (a) perceived social role satisfaction and (b) emotional distress, in young adult mentors.
- Impact of the iParent2Parent program on:
- perceived social support, (b) emotional distress, and (c) coping, in parent mentees. <!-- -->
- perceived social role satisfaction, and (b) emotional distress, in parent mentors.
A waitlist pilot RCT allows for an effective comparison of the study intervention with a control group receiving standard of care while not disadvantaging the control group who will have the option of participating in the intervention following the completion of the trial. This design therefore ensures that a potentially useful and effective intervention is accessible to all participants.
Up to 110 participants will be enrolled in the study from CHD programs in Toronto (SickKids/Toronto General Hospital), Edmonton (Stollery Children's Hospital/Mazankowski Alberta Heart Institute), Vancouver (BC Children's Hospital/St. Paul's Hospital), andMontreal (Ste. Justine/Montreal Heart Institute).
Up to 40 AYA (ages 16-25) and 40 parent mentees will be enrolled across the CHD programs, with about 10 AYA and about 10parent mentees per city.
Up to 15 young adults (ages 21-30) and 15 parent mentors will be enrolled across the adult sites of these CHD programs(Toronto General Hospital, Mazankowski Alberta Heart Institute, St. Paul's Hospital, and Montreal Heart Institute). The investigators anticipate 3-4 young adult mentors, and 3-4 parent mentors will be enrolled per site.
All mentees (40 mentees) will be asked to participate in semi-structured individual interviews at baseline (ME T1) and and all mentees in the intervention group (20 mentees) will be asked to participate in semi-structured interviews at 12 weeks - immediately post-intervention (ME T2). Interviews will be conducted by an interviewer trained in qualitative methods by telephone, in-person or virtually via the PHIPA-compliant version of Zoom or Microsoft Teams (depending on participants' preference), at a time that is convenient for the participant. Interviews will be guided by a semi-structured interview guide. ME T1 interviews will aim to assess motivations for participation, hopes and expectations, and preferences around mentor characteristics; and ME T2 interviews will aim to assess the primary outcomes evaluating feasibility.
All mentors (30 mentors) will be asked to participate in a focus group/semi-structured interview prior to mentor training (MR T1) and study end (MR T2). MR T1 focus groups/interviews will aim to assess motivations for participation and hopes and expectations, and MR T2 focus groups/interviews will aim to assess the primary outcomes evaluating feasibility. Focus groups/interviews will be conducted by an interviewer trained in qualitative methods. Focus groups/interviews will be conducted on a mutually agreed upon date and over the internet via a web-based video communication program (e.g., PHIPA-compliant version of Zoom or Microsoft Teams).
The semi-structured individual interviews and focus groups will be audiotaped, transcribed and analyzed using qualitative descriptive approach using thematic and content analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A pilot feasibility waitlist randomized controlled trial (RCT) design with repeated measures, and following CONSORT guidelines, will be used to evaluate the iP2P and iParent2Parent programs in AYA with CHD and their parents. A waitlist pilot RCT allows for an effective comparison of the study intervention with a control group receiving standard of care while not disadvantaging the control group who will have the option of participating in the intervention following the completion of the trial. This design therefore ensures that a potentially useful and effective intervention is accessible to all participants.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Peer mentorshipIn addition to their standard medical care, mentees in the experimental group will receive mentorship and support via the iP2P/iParent2Parent program. Trained mentors will provide information and support to mentee participants to encourage participation in self-management skill-building tailored to their needs. Each mentor will work with no more than two mentees at once for the study. Efforts will be made to pair mentors and mentees who share similar characteristics (e.g., similar disease severity, symptom profile, treatment regimen experiences, caregiver role, sex/gender, geographic area of residence). To ensure safety, a member of the research team will monitor all calls and messaging conversations as well as intervene in any potential safety concerns (e.g., discussion of suicidal ideation) or inappropriate behavior (e.g. bullying). |
| Waitlist control group | No intervention | –The control group will receive standard care without the iP2P/iParent2Parent intervention. The control group will be offered the iP2P/iParent2Parent intervention after completion of all outcome measures for a period of 12 weeks with the same research team support. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- AYA with CHD
- Parents of AYA with CHD
- Young adult mentors (1)21-30 year old with CHD (2) nominated by a member of their healthcare team as a good candidate to act in the mentor role based on maturity and emotional stability (e.g., good communication skills, positive adaptation and adjustment, strong support network), (3) willingness to commit to virtual peer mentor training, (4) able to speak and read English, (5) access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software.
- Parent mentors
Key exclusion criteria (12 listed)
- AYA mentees will be excluded if they: (1) have significant cognitive impairments as assessed by a qualified healthcare provider, or (2) have a diagnosis of an active psychological disorder (e.g., Major Depressive Disorder) likely to interfere with their ability to manage their care as determined by a qualified healthcare provider, or (3) received surgery for a CHD diagnosis in the last 6 months, or (4) have undergone a heart transplant, or (5) are participating in current peer support programs, or (6) are receiving end-of-life care.
- Parent mentees will be excluded if
- Young adult and parent mentors
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 |
|---|---|---|
| Peer mentorshipAlso: Peer mentoring, Peer supportThe iPeer2Peer/iParent2Parent intervention is a peer support mentorship program that will provide modelling and reinforcement by pre-screened and trained peer mentors to the mentees. The mentorship program will encourage mentees to develop and engage in self-management and transition skills and support the participants; practice of these skills. The mentors will provide information and support to mentee participants via 5-10 calls (using WhatsApp) of 20-30 minute durations and text messaging (using WhatsApp) for 12 weeks to encourage participation in self-management skill building tailored to their needs. | Behavioural | Intervention group |
Primary outcome
Recruitment and withdrawal rates
Time frame: 12 weeks
Recruitment rates (more than 70%) and withdrawal rates (less than 15%) as calculated using data recorded in participant recruitment log.
Adherence
Time frame: 12 weeks
Adherence with iP2P/iParent2Parent program (more than 80% rate of completion of at least five audio or video calls over 12 weeks and 100% rate of completion of all online outcome measures) as calculated using data recorded in participant program tracking log.
Acceptability/Level of engagement
Time frame: 12 weeks
Acceptability and level of engagement of the iP2P/iParent2Parent program intervention as measured through focus groups/interviews with mentors and interviews with mentees guided by the Theoretical Framework of Acceptability. Focus groups and interviews will take approximately 45 minutes per timepoint.
Barriers/Enablers
Time frame: 12 weeks
Barriers and enablers of the iP2P/iParent2Parent program intervention as measured through focus groups/interviews with mentors and interviews with mentees.
18 secondary outcomes
Perceived social role satisfaction (young adult mentor outcome)
Time frame: 12 weeks
Emotional distress (young adult mentor outcome)
Time frame: 12 weeks
Emotional distress (young adult mentor outcome)
Time frame: 12 weeks
Perceived social role satisfaction (parent mentor outcome)
Time frame: 12 weeks
Emotional distress (parent mentor outcome)
Time frame: 12 weeks
Emotional distress (parent mentor outcome)
Time frame: 12 weeks
Emotional distress (parent mentor outcome)
Time frame: 12 weeks
Transition readiness (adolescent/young adult mentee outcome)
Time frame: 12 and 24 weeks
Perceived social support (adolescent/young adult mentee outcome)
Time frame: 12 and 24 weeks
Emotional distress (adolescent/young adult mentee outcome)
Time frame: 12 and 24 weeks
Emotional distress (adolescent/young adult mentee outcome)
Time frame: 12 and 24 weeks
Mentor quality (adolescent/young adult mentee outcome)
Time frame: 12 and 24 weeks
Emotional distress (parent mentee outcome)
Time frame: 12 and 24 weeks
Emotional distress (parent mentee outcome)
Time frame: 12 and 24 weeks
Emotional distress (parent mentee outcome)
Time frame: 12 and 24 weeks
Coping (parent mentee outcome)
Time frame: 12 and 24 weeks
Mentor quality (parent mentee outcome)
Time frame: 12 and 24 weeks
Perceived social support (parent mentee outcome)
Time frame: 12 and 24 weeks
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 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease (CHD)
Recruiting
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
Congenital Heart Disease
Recruiting
A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study
Patient-Reported Outcome Measures (PROMs), Pragmatic Trial
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruitingObservational study
Echocardiographic Assessment of Valvular Dysfunction in Children With CHD
Congenital Heart Disease, Valvular Heart Disease
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer mentorship in people with Congenital Heart Disease (CHD) and Mentorship, 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 16 inclusion and 12 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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 Anthony (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?
Recruitment and withdrawal rates (time frame: 12 weeks). The study lists 4 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 27 Oct 2026.