iPeer2Peer Mentorship for Teen Heart Failure

(iP2P HF Trial)

Overseen By Sophie Bui, BHSc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Cognitive impairments, Psychological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

55 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests an online program where young adults mentor younger teens with the same health condition. The goal is to help teens manage their condition better by learning from someone who has been through similar experiences. Mentors and mentees will connect over several months using video calls and text messages.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on peer support and mentoring rather than medication changes.

What data supports the effectiveness of the iPeer2Peer Program treatment for teen heart failure?

While there is no direct data on the iPeer2Peer Program for teen heart failure, a similar multidisciplinary heart failure management program showed improved survival rates in adults by providing structured education and monitoring. This suggests that supportive programs involving education and monitoring could potentially benefit teens with heart failure as well. ^{1 2 3 4 5}

How is the iPeer2Peer Program treatment different from other treatments for teen heart failure?

The iPeer2Peer Program is unique because it uses peer support, where teens with heart failure are mentored by others who have similar experiences, to improve self-care and coping skills. This approach is different from traditional medical treatments, which typically focus on medications and physical therapies. ^{1 3 6 7 8}

Research Team

Samantha J Anthony, PhD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

This trial is for teens with heart failure aged 12-17 who are at least 4 months post-diagnosis, and young adults aged 18-25 as mentors. Mentees must commit to regular communication with a mentor over 15 weeks. Mentors need good communication skills, emotional stability, and willingness to train and support mentees. Excluded are those in other peer programs or with significant cognitive impairments or active psychological disorders.

Inclusion Criteria

I am 18-25, speak English, and can mentor a heart failure patient online.

I am a teen with heart failure, willing to communicate regularly with a mentor.

Exclusion Criteria

I do not have a psychological disorder that affects my daily life or heart care.

You are currently involved in other support or self-care programs.

A healthcare provider has determined that you have serious problems with thinking and remembering.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mentor Training

Mentors undergo training in mentoring and the use of eHealth technology

2 weeks

Mentorship Program

Mentor-mentee pairings connect over 15 weeks through video calls and text messaging to provide peer support and encourage disease self-management skills

15 weeks

Regular virtual meetings

Follow-up

Participants are monitored for outcomes such as appropriateness, adoption, feasibility, and acceptability

12 weeks post-program completion

Treatment Details

Interventions

• iPeer2Peer Program

Trial Overview The iP2P program is being tested to see if it helps teen heart failure patients manage their condition better through online peer mentorship. Participants will be randomly assigned to start the program immediately or after a waiting period (waitlist). They'll use video calls and texts for support over a period of 15 weeks.

Participant Groups

Group I: iPeer2Peer Program Experimental Treatment 1 Intervention

Group II: Standard of Care Waitlist Control Group Active Control 1 Intervention

iPeer2Peer Program is already approved in Canada for the following indications:

Approved in Canada as iPeer2Peer Program for:

• Chronic disease management
• Congenital heart disease
• Thoracic transplant recipients
• Solid organ transplantation

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

The Centre Hospitalier Universitaire Sainte-Justine

Collaborator

Trials

1

Recruited

60+

British Columbia Children's Hospital

Collaborator

Trials

27

Recruited

15,600+

University of Alberta/Stollery Children's Hospital

Collaborator

Trials

2

Recruited

90+

Findings from Research

A survey of 100 pediatric cardiologists across 27 European countries revealed that ACE inhibitors (ACE-I) are widely prescribed for treating heart failure in children, particularly for conditions like dilated cardiomyopathy and congenital heart defects, although 26% of physicians avoid using them in newborns.

There is significant variability in the starting and maintenance doses of ACE-I, as well as in the drug regimens used for heart failure, indicating a lack of standardization that could affect the safety and efficacy of treatments for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapeutic management of paediatric heart failure and ACE-I use patterns: a European survey. Castro Díez, C., Khalil, F., Schwender, H., et al.[2022]

A new pediatric treatment intensity score (TIS) was developed to quantify the burden of illness in children with advanced heart failure on ventricular assist devices (VADs), assessing factors like nutrition and respiratory support.

The TIS showed good reliability in a study of 39 patients, indicating that higher scores reflect greater morbidity and that the tool can effectively track clinical recovery after VAD implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel pediatric treatment intensity score: development and feasibility in heart failure patients with ventricular assist devices. May, LJ., Ploutz, M., Hollander, SA., et al.[2015]

Acute pediatric heart failure management focuses on assessing a child's perfusion and volume status to guide treatment, adapting strategies from adult studies that highlight the risks associated with poor hemodynamics.

Chronic pediatric heart failure is typically treated with a combination of medications including ACE inhibitors, beta-blockers, and spironolactone, while intravenous milrinone is used for children with refractory cases awaiting heart transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical management of pediatric heart failure. Ahmed, H., VanderPluym, C.[2021]

Adolescents and young adults (AYAs) with heart failure experience significant impairments in health-related quality of life (HRQOL), particularly those with conditions like dilated or hypertrophic cardiomyopathy, congenital heart disease, or post-transplant complications.

Factors such as being female and identifying as white are associated with poorer self-reported physical functioning, while functional status is strongly linked to overall HRQOL, highlighting the need for targeted interventions for those at greater risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Disease, Sex, and Racial Differences in Health-Related Quality of Life in Adolescents and Young Adults with Heart Failure. Cousino, MK., Lim, HM., Smith, C., et al.[2022]

A multicenter study involving 1816 heart failure patients showed that a community-based multidisciplinary disease management program (DMP) significantly reduced 1-year all-cause mortality, with a hazard ratio of 0.65, indicating a 35% lower risk of death compared to standard care.

The DMP included structured patient education, home monitoring by trained nurses, and alerts for significant clinical changes, demonstrating that coordinated care can improve survival outcomes for heart failure patients after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a multidisciplinary heart failure disease management programme on 1-year mortality: Prospective cohort study. Laborde-Castérot, H., Agrinier, N., Zannad, F., et al.[2022]

A randomized controlled trial involving 9 trained mentors showed that peer support significantly improved heart failure self-care among patients over a 3-month period (P < .05).

Despite the positive impact on self-care, the intervention group experienced a 96% higher heart failure readmission rate compared to the control group, indicating that while peer support can help with self-management, it may not reduce hospitalizations without additional professional education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is individual peer support a promising intervention for persons with heart failure? Riegel, B., Carlson, B.[2019]

In the REHAB-HF trial, a tailored physical rehabilitation program for older patients with acute heart failure showed that higher adherence to the program (67% attendance) was linked to significant improvements in physical function and quality of life, as measured by various scales.

Patients who attended more sessions experienced better outcomes, including increased physical performance, reduced depression, and lower rates of rehospitalization, highlighting the importance of adherence in maximizing the benefits of rehabilitation interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention Adherence in REHAB-HF: Predictors and Relationship With Physical Function, Quality of Life, and Clinical Events. Nelson, MB., Gilbert, ON., Duncan, PW., et al.[2022]

A systematic review of three studies involving 390 heart failure patients found that peer support may slightly increase mortality rates, although the evidence is of low certainty.

The analysis showed no significant improvement in readmission rates or quality of life for patients receiving peer support, suggesting that endorsing this approach for heart failure patients is currently unjustifiable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Support for Patients With Heart Failure: A Systematic Review and Meta-Analysis. Nakao, S., Kamo, T., Someko, H., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapeutic management of paediatric heart failure and ACE-I use patterns: a European survey. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A novel pediatric treatment intensity score: development and feasibility in heart failure patients with ventricular assist devices. [2015]

3. China pubmed.ncbi.nlm.nih.gov

Medical management of pediatric heart failure. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Primary Disease, Sex, and Racial Differences in Health-Related Quality of Life in Adolescents and Young Adults with Heart Failure. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a multidisciplinary heart failure disease management programme on 1-year mortality: Prospective cohort study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Is individual peer support a promising intervention for persons with heart failure? [2019]

7. England pubmed.ncbi.nlm.nih.gov

Intervention Adherence in REHAB-HF: Predictors and Relationship With Physical Function, Quality of Life, and Clinical Events. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Peer Support for Patients With Heart Failure: A Systematic Review and Meta-Analysis. [2023]