The iPeer2Peer Mentorship Program for Young Adults With Heart Disease

Официальное название

The iPeer2Peer Support Mentorship Program for Young Adult Patients With Heart Disease: A Feasibility Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Peer Mentorship
  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) f

Первичные конечные точки

• Recruitment and withdrawal rates [Срок оценки: Baseline to study completion]
• Level of engagement [Срок оценки: 12 weeks]
• Adherence [Срок оценки: 12 weeks]
• Acceptability [Срок оценки: 12 weeks]
• Barriers and enablers [Срок оценки: 12 weeks]

Вторичные конечные точки (8)

• Perceived social role satisfaction (Mentors) [Срок оценки: Baseline to study completion, an average of 1 year]
• Emotional distress (Mentors) [Срок оценки: Baseline to study completion, an average of 1 year]
• Hope (Mentors) [Срок оценки: Baseline to study completion, an average of 1 year]
• Disease self-management (Mentees) [Срок оценки: Baseline to 12 weeks post-program completion and 24 weeks post-program completion]
• Percevied social support (Mentees) [Срок оценки: Baseline to 12 weeks post-program completion and 24 weeks post-program completion]
• Emotional distress (Mentees) [Срок оценки: Baseline to 12 weeks post-program completion and 24 weeks post-program completion]
• Resiliency (Mentees) [Срок оценки: Baseline to 12 weeks post-program completion and 24 weeks post-program completion]
• Hope (Mentees) [Срок оценки: Baseline to 12 weeks post-program completion and 24 weeks post-program completion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• The Hospital for Sick Children — Toronto

Идентификаторы

NCT: NCT07119216 · CTO5006 · G-24-0036451

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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