iPeer2Peer Mentorship for Teen Heart Failure
(iP2P HF Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Hospital for Sick Children
Disqualifiers: Cognitive impairments, Psychological disorders, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345How 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.
13678Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: iPeer2Peer ProgramExperimental Treatment1 Intervention
Group II: Standard of Care Waitlist Control GroupActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Hospital for Sick ChildrenToronto, Canada
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Who Is Running the Clinical Trial?
The Hospital for Sick ChildrenLead Sponsor
The Centre Hospitalier Universitaire Sainte-JustineCollaborator
British Columbia Children's HospitalCollaborator
University of Alberta/Stollery Children's HospitalCollaborator
References
Pharmacotherapeutic management of paediatric heart failure and ACE-I use patterns: a European survey. [2022]To characterise heart failure (HF) maintenance pharmacotherapy for children across Europe and investigate how angiotensin-converting enzyme inhibitors (ACE-I) are used in this setting.
A novel pediatric treatment intensity score: development and feasibility in heart failure patients with ventricular assist devices. [2015]The evolution of pharmacologic therapies and mechanical support including ventricular assist devices (VADs) has broadened the scope of care available to children with advanced heart failure. At the present time, there are only limited means of quantifying disease severity or the concomitant morbidity for this population. This study describes the development of a novel pediatric treatment intensity score (TIS), designed to quantify the burden of illness and clinical trajectory in children on VAD support.
Medical management of pediatric heart failure. [2021]Pediatric heart failure is a complex, heterogenous syndrome that occurs relatively rarely in children, but carries a high burden of morbidity and mortality. This article reflects on the current state of medical therapy for both acute and chronic pediatric heart failure, based on expert consensus guidelines, and the extrapolation of data from trials performed in adults. For the management of acute heart failure specifically, we rely on an initial assessment of the perfusion and volume status of a patient, to guide medical therapy. This paradigm was adapted from adult studies that demonstrated increased morbidity and mortality in heart failure patients whose hemodynamics or examination findings were consistent with a PCWP >18 mmHg and a CI ≤2.2 L/min/m2. The cornerstone of treatment in the acute setting therefore relies on achieving a euvolemic state with adequate cardiac output. In the chronic setting, patients are typically maintained on a regimen of an angiotensin converting enzyme inhibitor, a beta-blocker, and spironolactone. For those with refractory heart failure, intravenous milrinone therapy has become a mainstay of bridging children to cardiac transplantation. The pediatric-specific data driving these clinical practices are limited and often times, conflicting. The future of pediatric heart failure depends on collaboration, quality improvement, and a commitment to pediatric-specific indications for new medical and device therapies.
Primary Disease, Sex, and Racial Differences in Health-Related Quality of Life in Adolescents and Young Adults with Heart Failure. [2022]Health-related quality of life (HRQOL) is an important clinical and research trial endpoint in adult heart failure and has been shown to predict mortality and hospitalizations in adult heart failure populations. HRQOL has not been adequately studied in the growing pediatric and young adult heart failure population. This study described HRQOL in adolescents and young adults (AYAs) with heart failure and examined primary disease, sex, race, and other correlates of HRQOL in this sample. Participants in this cross-sectional, single-center study included adolescent and young adults with heart failure and a parent/guardian. Patients and their parent/proxies completed the PedsQL, a well-established measure of HRQOL in pediatric chronic illness populations. HRQOL is impaired in AYAs with heart failure resulting from dilated, hypertrophic, or other cardiomyopathy, congenital heart disease, or post-transplant with rejection/complications. Patients identifying as white endorsed poorer total HRQOL than non-white patients (p = 0.002). Subscale analysis revealed significant correlations between female sex (p = 0.01) and white race (p = 0.01) with poorer self-reported physical functioning. Family income was unrelated to HRQOL. Functional status was strongly associated with total (p = 0.0003) and physical HRQOL (p
Effectiveness of a multidisciplinary heart failure disease management programme on 1-year mortality: Prospective cohort study. [2022]We performed a multicenter prospective observational cohort study (Epidémiologie et Pronostic de l'Insuffisance Cardiaque Aiguë en Lorraine, Epidemiology and Prognosis of Acute Heart Failure in Lorraine [EPICAL2]) to evaluate the effectiveness on mortality of a community-based multidisciplinary disease management programme (DMP) for heart failure (HF) patients.Between October 2011 and October 2012, 1816 patients, who were hospitalized for acute HF or who developed acute HF during a hospitalization, were included from 21 hospitals in a northeast region of France. At hospital admission, their mean age was 77.3 (standard deviation [SD] 11.6) years and mean left ventricular ejection fraction was 45.0 (SD 16.0)%. A subset of patients were enrolled in a multidimensional DMP for HF (n = 312, 17.2%), based on structured patient education, home monitoring visits by HF-trained nurses, and automatic alerts triggered by significant clinical and biological changes to the patient. The DMP involved general practitioners, nurses, and cardiologists collaborating via an individual web-based medical electronic record. The outcome was all-cause mortality from the 3rd to the 12th month after discharge. During the follow-up, a total of 377 (20.8%) patients died: 321 (21.3%) in the control group and 56 (17.9%) in the DMP group. In a propensity score analysis, DMP was associated with lower 1-year all-cause mortality (hazard ratio 0.65, 95% CI 0.46-0.92). Instrumental variable analysis gave similar results (hazard ratio 0.56, 0.27-1.16).In a real world setting, a multidimensional DMP for HF with structured patient education, home nurse monitoring, and appropriate physician alerts may improve survival when implemented after discharge from hospitalization due to worsening HF.
Is individual peer support a promising intervention for persons with heart failure? [2019]Peer support has been used effectively in a variety of patient populations, but its effectiveness in improving outcomes in persons with chronic heart failure has not been explored. We trained 9 persons with heart failure to mentor other heart failure patients and tested the effectiveness of this approach in a randomized controlled clinical trial. A low proportion (37%) of the eligible population of hospitalized patients agreed to participate. At the end of the 3-month trial, there was significantly higher heart failure self-care in the intervention group (P
Intervention Adherence in REHAB-HF: Predictors and Relationship With Physical Function, Quality of Life, and Clinical Events. [2022]Background The REHAB-HF (Rehabilitation Therapy in Older Acute Heart Failure Patients) trial showed that a novel, early, transitional, tailored, progressive, multidomain physical rehabilitation intervention improved physical function and quality of life in older, frail patients hospitalized for acute decompensated heart failure. This analysis examined the relationship between intervention adherence and outcomes. Methods and Results Adherence was defined as percent of sessions attended and percent of sessions attended adjusted for missed sessions for medical reasons. Baseline characteristics were examined to identify predictors of session attendance. Associations of session attendance with change in physical function (Short Physical Performance Battery [primary outcome], 6-minute walk distance, quality of life [Kansas City Cardiomyopathy Questionnaire], depression, and clinical events [landmarked postintervention]) were examined in multivariate analyses. Adherence was 67%±34%, and adherence adjusted for missed sessions for medical reasons was 78%±34%. Independent predictors of higher session attendance were the following: nonsmoking, absence of myocardial infarction history and depression, and higher baseline Short Physical Performance Battery. After adjustment for predictors, adherence was significantly associated with larger increases in Short Physical Performance Battery (parameter estimate: β=0.06[0.03-0.10], P=0.001), 6-minute walk distance (β=1.8[0.2-3.5], P=0.032), and Kansas City Cardiomyopathy Questionnaire score (β=0.62[0.26-0.98], P=0.001), and reduction in depression (β=-0.08[-0.12 to 0.04], P<0.001). Additionally, higher adherence was significantly associated with reduced 6-month all-cause rehospitalization (rate ratio: 0.97 [0.95-0.99], P=0.020), combined all-cause rehospitalization and death (0.97 [0.95-0.99], P=0.017), and all-cause rehospitalization days (0.96 [0.94-0.99], P=0.004) postintervention. Conclusions In older, frail patients with acute decompensated heart failure, higher adherence was significantly associated with improved patient-centered and clinical event outcomes. These data support the efficacy of the comprehensive adherence plan and the subsequent intervention-related benefits observed in REHAB-HF. Registration URL: https://clinicaltrials.gov/; Unique identifier: NCT02196038.
Peer Support for Patients With Heart Failure: A Systematic Review and Meta-Analysis. [2023]Peer support, which is given by people with similar life experiences and experiential knowledge, has been shown to be effective for patients with diabetes and mental illness. However, the impact of such peer support on patients coping with heart failure remains indeterminate. The objective of this systematic review and meta-analysis is to scrutinize the potential benefits of peer support for patients with heart failure. We included randomized controlled trials (RCTs) evaluating the effectiveness of peer support for patients with heart failure in contrast to those without peer support. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov until October 2022. We pooled the data on mortality, readmission rate, and quality of life (QoL) as primary outcomes. The certainty of evidence was evaluated by the grading of recommendations assessment, development, and evaluation (GRADE) approach. We included three studies with 390 patients with heart failure. Peer support may have resulted in a slight increase in mortality (risk ratio (RR)=1.16, 95% confidence interval (CI)=0.61-2.21; low certainty of the evidence) and in a reduction in the readmission rate (RR=0.93, 95% CI=0.74-1.17; low certainty of the evidence). The evidence was very uncertain about the effect of peer support on QoL (standardized mean difference 2.03 higher in the intervention group, 95% CI=1.79 lower to 5.84 higher; very low certainty of the evidence). Despite that the certainty is low or very low, the extant data available evidence suggests that peer support may not yield substantial improvements in critical outcomes for patients with heart failure. Consequently, endorsing peer support for patients with heart failure currently seems unjustifiable.