The iPeer2Peer Support Mentorship Program for Young Adult Patients With Heart Disease: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recruitment and withdrawal rates
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The randomization process will be blinded to the principal investigator and co-investigators to reduce the chance of experimenter bias. Mentees and mentors will be asked not to discuss their study involvement with others outside of the study team until study completion.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention group
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).
干预措施: Peer Mentorship (Behavioral)
Waitlist control
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.
结局指标
主要结局
Recruitment and withdrawal rates
时间窗: 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
时间窗: 12 weeks
Measured via semi-structured interviews or focus groups.
Adherence
时间窗: 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
时间窗: 12 weeks
When the innovation is agreeable, palatable or satisfactory. Measured via focus groups or semi-structued interviews.
Barriers and enablers
时间窗: 12 weeks
Measured via semi-structued interviews or focus groups.
次要结局
- Percevied social support (Mentees)(Baseline to 12 weeks post-program completion and 24 weeks post-program completion)
- Perceived social role satisfaction (Mentors)(Baseline to study completion, an average of 1 year)
- Emotional distress (Mentors)(Baseline to study completion, an average of 1 year)
- Hope (Mentors)(Baseline to study completion, an average of 1 year)
- Disease self-management (Mentees)(Baseline to 12 weeks post-program completion and 24 weeks post-program completion)
- Emotional distress (Mentees)(Baseline to 12 weeks post-program completion and 24 weeks post-program completion)
- Resiliency (Mentees)(Baseline to 12 weeks post-program completion and 24 weeks post-program completion)
- Hope (Mentees)(Baseline to 12 weeks post-program completion and 24 weeks post-program completion)
研究者
Samantha Anthony
Health Clinician Scientist
The Hospital for Sick Children