Heart FailureNCT07119216
The iPeer2Peer Mentorship Program for Young Adults With Heart Disease
A study testing Peer Mentorship in people with Heart Failure and Mentorship, run by Samantha Anthony at 1 site in Canada.
Trial summary
Young adults with heart failure, including those who have undergone a heart transplant, experience considerable psychosocial stressors associated with living with a chronic illness, including heightened levels of anxiety and depression, and poor health-related quality of life compared to 'healthy' peers. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Heart Failure, Mentorship, Peer Support
- 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
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2025to 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Peer Mentor inclusion criteria: (a) heart disease patients, (b) at least three months post-diagnosis, (c) between the ages of 26-35 years old, (d) 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), (e) willingness to commit to virtual peer mentor training, (f) able to speak and read English, and (g) access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software.
- Peer Mentee inclusion criteria: (a) heart disease patients, (b) between the ages of 18-25 years old, (c) able to speak and read English, and (d) access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software.
- Heart disease patients include:
- Patients with any past or present heart failure
- Patients with cardiomyopathy seen at least 2 times a year
- Patients who have undergone a Fontan procedure
- Patients who have undergone a heart transplant
Who cannot join
- Mentor and mentee exclusion criteria include: (a) Significant cognitive impairments as assessed by a qualified healthcare provider (HCP), (b) 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 heart disease care regimen, and (c) 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: The iPeer2Peer Support Mentorship Program for Young Adult Patients With Heart Disease: A Feasibility Study
Young adults with heart failure, including those who have undergone a heart transplant, experience considerable psychosocial stressors associated with living with a chronic illness, including heightened levels of anxiety and depression, and poor health-related quality of life compared to 'healthy' peers. Psychosocial challenges during young adulthood are especially concerning as this life stage represents a unique transitional period for fostering self-identity, friendships, mastery, and decision-making competencies. As young people with heart failure transition into adult healthcare systems, they take on greater personal responsibility due to their increasing independence and involvement in care decisions, and require more support and resources to live longer, healthier lives. 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.
An established, online mentorship program, iPeer2Peer (iP2P), will be employed through a pilot feasibility waitlist randomized controlled trial with repeated measures across five sites. Sixty mentees will be recruited and randomized into intervention and control groups. Thirty mentees in the intervention group will be matched 1:1 with 20 trained 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 the iP2P program in terms of participant: (a) recruitment and withdrawal rates, (b) adherence with the program, (c) perceptions regarding the acceptability and level of engagement in the iP2P program, and (d) perceptions of barriers and enablers of the iP2P program.
Secondary Objective: to explore the iP2P program's impact on preliminary psychosocial outcomes in:
i.Mentees- (a) disease self-management, (b) perceived social support, (c) emotional distress, (d) resiliency and (e) hope; ii.Mentors- (a) perceived social role satisfaction, (b) emotional distress, and (c) hope.
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.
Up to 80 participants will be enrolled in this study at five sites: Mazankowski Alberta Heart Institute (Edmonton), St. Boniface Hospital (Winnipeg), Toronto General Hospital (Toronto), the University of British Columbia Division of Cardiology - Vancouver General Hospital and St Paul's Hospital (Vancouver).
We expect 20 adult mentors and 60 young adult mentees will be enrolled across these sites, with 4-6 mentors and about 10-15 mentees per site. The mentees will be randomized to the experimental (iP2P program; n=30) or control (waitlist; n=30) group. Mentees assigned to the waitlist will receive the iP2P program once all outcome measures are complete.
All mentees will be asked to participate in semi-structured individual interviews at baseline (ME T1) and and all mentees in the intervention group 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 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
- Heart Failure, Mentorship, Peer Support, Peer Support and Chronic Disease, Young Adults, Cardiomyopathies
- Being tested
- Peer Mentorship
- Keywords
- heart failure, mentorship, peer support, young adult, heart disease
- Medical subject headings
- Heart Failure, Chronic Disease, Cardiomyopathies, Heart Diseases
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 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 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 | No intervention | The control group will receive standard care without the iP2P intervention. The control group will be offered the iP2P 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
(a) Recruitment rates (more than 70%) and withdrawal rates (less than 15%) as calculated using data recorded in participant recruitment log.
Measured: Baseline to study completion
Level of engagement
Measured via semi-structured interviews or focus groups.
Measured: 12 weeks
Adherence
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
When the innovation is agreeable, palatable or satisfactory. Measured via focus groups or semi-structued interviews.
Measured: 12 weeks
Barriers and enablers
Measured via semi-structued interviews or focus groups.
Measured: 12 weeks
Secondary outcomes (8)
Perceived social role satisfaction (Mentors)
Measured by the PROMIS Satisfaction with Social Roles and Activities
Measured: Baseline to study completion, an average of 1 year
Emotional distress (Mentors)
Measured by the General Anxiety Disorder-7 and the Patient Health Questionnaire Depression Scale
Measured: Baseline to study completion, an average of 1 year
Hope (Mentors)
Measured by the Adult Hope Scale
Measured: Baseline to study completion, an average of 1 year
Disease self-management (Mentees)
Measured by the Partners in Health Scale
Measured: Baseline to 12 weeks post-program completion and 24 weeks post-program completion
Percevied social support (Mentees)
Measured by the Multidimensional Scale of Perceived Social Support
Measured: Baseline to 12 weeks post-program completion and 24 weeks post-program completion
Emotional distress (Mentees)
Measured by the General Anxiety Disorder-7 and the Patient Health Questionnaire Depression Scale
Measured: Baseline to 12 weeks post-program completion and 24 weeks post-program completion
Resiliency (Mentees)
Measured by the Brief Resilience Scale
Measured: Baseline to 12 weeks post-program completion and 24 weeks post-program completion
Hope (Mentees)
Measured by the Adult Hope Scale
Measured: Baseline to 12 weeks post-program completion and 24 weeks post-program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study startSep 2025 (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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A mixed methods pilot feasibility waitlist randomized controlled trial (RCT) design using central randomization with repeated measures, and following CONSORT guidelines, will be used to evaluate the iP2P program in young adult patients with heart disease. For clinical interventions, feasibility studies serve to identify potential refinements to the intervention, address uncertainties around the feasibility of intervention trial methods or test preliminary effects of the intervention. 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samantha Anthony
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor-investigator, Samantha Anthony, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119216
- Sponsor's protocol ID
- CTO5006
- Other IDs
- G-24-0036451
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 13 Aug 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The iPeer2Peer Support Mentorship Program for Young Adult Patients With Heart Disease: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07119216
- Acronym / sponsor ID
- CTO5006
- Conditions
- Heart Failure, Mentorship, Peer Support, Peer Support and Chronic Disease, Young Adults, Cardiomyopathies
- Keywords
- heart failure, mentorship, peer support, young adult, heart disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Samantha AnthonyUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Aug 2025 (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.
Young adults with heart failure, including those who have undergone a heart transplant, experience considerable psychosocial stressors associated with living with a chronic illness, including heightened levels of anxiety and depression, and poor health-related quality of life compared to 'healthy' peers. Psychosocial challenges during young adulthood are especially concerning as this life stage represents a unique transitional period for fostering self-identity, friendships, mastery, and decision-making competencies. As young people with heart failure transition into adult healthcare systems, they take on greater personal responsibility due to their increasing independence and involvement in care decisions, and require more support and resources to live longer, healthier lives. 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.
An established, online mentorship program, iPeer2Peer (iP2P), will be employed through a pilot feasibility waitlist randomized controlled trial with repeated measures across five sites. Sixty mentees will be recruited and randomized into intervention and control groups. Thirty mentees in the intervention group will be matched 1:1 with 20 trained 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 the iP2P program in terms of participant: (a) recruitment and withdrawal rates, (b) adherence with the program, (c) perceptions regarding the acceptability and level of engagement in the iP2P program, and (d) perceptions of barriers and enablers of the iP2P program.
Secondary Objective: to explore the iP2P program's impact on preliminary psychosocial outcomes in:
i.Mentees- (a) disease self-management, (b) perceived social support, (c) emotional distress, (d) resiliency and (e) hope; ii.Mentors- (a) perceived social role satisfaction, (b) emotional distress, and (c) hope.
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.
Up to 80 participants will be enrolled in this study at five sites: Mazankowski Alberta Heart Institute (Edmonton), St. Boniface Hospital (Winnipeg), Toronto General Hospital (Toronto), the University of British Columbia Division of Cardiology - Vancouver General Hospital and St Paul's Hospital (Vancouver).
We expect 20 adult mentors and 60 young adult mentees will be enrolled across these sites, with 4-6 mentors and about 10-15 mentees per site. The mentees will be randomized to the experimental (iP2P program; n=30) or control (waitlist; n=30) group. Mentees assigned to the waitlist will receive the iP2P program once all outcome measures are complete.
All mentees will be asked to participate in semi-structured individual interviews at baseline (ME T1) and and all mentees in the intervention group 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 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 mixed methods pilot feasibility waitlist randomized controlled trial (RCT) design using central randomization with repeated measures, and following CONSORT guidelines, will be used to evaluate the iP2P program in young adult patients with heart disease. For clinical interventions, feasibility studies serve to identify potential refinements to the intervention, address uncertainties around the feasibility of intervention trial methods or test preliminary effects of the intervention. 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.
| 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 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 | No intervention | –The control group will receive standard care without the iP2P intervention. The control group will be offered the iP2P intervention after completion of all outcome measures for a period of 12 weeks with the same research team support. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Peer Mentor inclusion criteria: (a) heart disease patients, (b) at least three months post-diagnosis, (c) between the ages of 26-35 years old, (d) 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), (e) willingness to commit to virtual peer mentor training, (f) able to speak and read English, and (g) access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software.
- Peer Mentee inclusion criteria: (a) heart disease patients, (b) between the ages of 18-25 years old, (c) able to speak and read English, and (d) access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software.
- Patients with any past or present heart failure
- Patients with cardiomyopathy seen at least 2 times a year
- Patients who have undergone a Fontan procedure
Key exclusion criteria (1 listed)
- Mentor and mentee exclusion criteria include: (a) Significant cognitive impairments as assessed by a qualified healthcare provider (HCP), (b) 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 heart disease care regimen, and (c) are 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 |
|---|---|---|
| Peer MentorshipAlso: Peer mentoring, Peer supportThe iPeer2Peer 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: Baseline to study completion
(a) Recruitment rates (more than 70%) and withdrawal rates (less than 15%) as calculated using data recorded in participant recruitment log.
Level of engagement
Time frame: 12 weeks
Measured via semi-structured interviews or focus groups.
Adherence
Time frame: 12 weeks
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
Time frame: 12 weeks
When the innovation is agreeable, palatable or satisfactory. Measured via focus groups or semi-structued interviews.
Barriers and enablers
Time frame: 12 weeks
Measured via semi-structued interviews or focus groups.
8 secondary outcomes
Perceived social role satisfaction (Mentors)
Time frame: Baseline to study completion, an average of 1 year
Emotional distress (Mentors)
Time frame: Baseline to study completion, an average of 1 year
Hope (Mentors)
Time frame: Baseline to study completion, an average of 1 year
Disease self-management (Mentees)
Time frame: Baseline to 12 weeks post-program completion and 24 weeks post-program completion
Percevied social support (Mentees)
Time frame: Baseline to 12 weeks post-program completion and 24 weeks post-program completion
Emotional distress (Mentees)
Time frame: Baseline to 12 weeks post-program completion and 24 weeks post-program completion
Resiliency (Mentees)
Time frame: Baseline to 12 weeks post-program completion and 24 weeks post-program completion
Hope (Mentees)
Time frame: Baseline to 12 weeks post-program completion and 24 weeks post-program completion
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 13 Aug 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.
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 Heart Failure and Mentorship, run by Samantha Anthony 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 7 inclusion and 1 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 13 Aug 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 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: Baseline to study completion). The study lists 5 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 13 Aug 2025.