Enhancing Caregiver Wellbeing: The Role of Exercise, Nutrition, and Stress Management for Caregivers of Patients With Advanced Cardiac and Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Study Recruitment According to Research Team Records
研究概览
简要总结
Caregivers provide essential support for people living with advanced heart or lung disease, including daily tasks, emotional support, and help with medical care. Although their role is vital, caregivers often experience high levels of stress, fatigue, and challenges with their own health and well-being. This study will test whether it is possible and practical to offer an 8-week wellness program for caregivers that is delivered virtually in their homes. The program includes personalized strategies for physical activity or exercise, healthy eating, and stress management. It will be tailored to the individual needs and schedules of caregivers and supported by regular virtual check-ins with health professionals. We will evaluate whether caregivers find the program acceptable, safe, and feasible to follow. This includes looking at how many caregivers agree to participate, how many complete the program, whether they can follow the activities, and whether they are satisfied with the experience. The study will also explore whether participating in the program may lead to improvements in caregiver quality of life, stress, and confidence in the caregiving role.
详细描述
Caregivers of people with advanced cardiac or pulmonary disease play a critical role in supporting patients' health. Their responsibilities often include transportation, managing appointments, grocery shopping, personal care, and emotional support. This role, while essential, is demanding and has been associated with higher levels of stress, lower physical activity, sleep disruption, and worse quality of life among caregivers. Over time, these challenges can negatively impact both the caregiver's own health and their ability to continue providing support.
Most existing wellness or rehabilitation programs focus on the patient rather than the caregiver. As a result, caregivers have limited access to structured support designed specifically for their own health needs. Previous research in patients with advanced disease and transplant recipients has shown that virtual programs combining exercise, nutrition counselling, and stress management are feasible, safe, and acceptable. These programs were able to improve aspects of physical and emotional well-being, demonstrating that remotely delivered interventions can be effective in populations with significant health challenges.
Given this evidence, it is important to extend support directly to caregivers, who are often overlooked despite being at high risk for stress-related health problems. Addressing this gap has the potential to improve both caregiver outcomes and the care they provide to patients.
The investigators are testing a flexible, home-based wellness program designed to support the physical and emotional well-being of caregivers of people living with serious heart or lung disease. This study will look at whether the program is practical to deliver, whether caregivers are able to follow it, and whether it shows signs of being helpful. This information will help the researchers decide if it is worth doing a larger study in the future. This study will also look at how the program affects caregivers' quality of life, mental health, and their relationship with the person they care for. In addition, caregivers and patients will have the option to share their experiences in interviews, which may take place before, during, or up to approximately 4 weeks after the program.
This study will examine whether it is feasible to recruit and retain caregivers into an 8-week, home-based wellness program and whether caregivers can safely participate in the intervention. The investigators expect that caregivers will find the program acceptable and that it will be possible to deliver physical activity, nutrition counselling, and stress management strategies in a virtual format. In addition, the study will explore preliminary signals of benefit, including improvements in caregiver quality of life, stress, and psychosocial well-being. Finally, exploratory qualitative interviews will examine whether supporting caregivers in this way may also influence patient experiences and the caregiver-patient relationship.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(CAREGIVERS):
- •Informal (unpaid) caregivers aged 18 years or older
- •Identified as the primary caregiver of a patient with advanced cardiac or pulmonary disease receiving outpatient palliative care at Toronto General Hospital
- •Ability to provide informed consent
排除标准
- •(CAREGIVERS):
- •Presence of any medical condition where moderate physical activity or exercise training would be contraindicated (e.g., unstable cardiovascular disease, recent injury)
- •Significant cognitive impairment or language barrier that would interfere with completing study procedures
- •Lack of access to a phone or internet connection to enable virtual participation
- •INCLUSION CRITERIA (Patients):
- •Aged 18 years or older
- •Diagnosis of advanced cardiac or pulmonary disease and currently receiving outpatient palliative care at Toronto General Hospital
- •Ability to provide informed consent
- •EXCLUSION CRITERIA (Patients):
- •Significant cognitive impairment or language barrier that would interfere with completing study procedures
- •Medical instability that would preclude participation in an interview or completion of questionnaires, as determined by the clinical team
- •Lack of access to a phone or internet connection to enable virtual participation
研究组 & 干预措施
Multimodal Caregiver Well-being Intervention
The intervention in this study is an 8-week, individualized, home-based Multimodal Caregiver Wellness Program, which includes three core components: flexible physical activity or exercise program tailored to the goals of caregivers, nutritional counselling (interventional group only), and stress management strategies delivered through the exercise professional and dietician.
干预措施: Multimodal Well-being Program (Behavioral)
Usual care
The usual care group will recieive the UHN caregiver resource pamphlet and standard caregiver resources offered at UHN such as access to social work, psychology, and palliative care support as needed.
Patients (Optional)
Up to 40 patients known to the caregivers will be invited to participate in the study to complete questionnaires and will have the option of participating in a qualitative interview. Patients will not receive any intervention. Patient participation is optional and not required for caregiver enrollment in the study.
结局指标
主要结局
Study Recruitment According to Research Team Records
时间窗: Over study recruitment period (approximately 15 months)
Recruitment-success percentage in the study will be assessed based on research team study records.
Study Consent Rates According to Research Team Records
时间窗: Over study recruitment period (approximately 15 months)
Consent-success percentage in the study and reasons for declining participation will be assessed based on research team study records.
Self-Reported Adherence to Multimodal Well-being Program According to Participant Logs (Intervention Group Only)
时间窗: During the study intervention period (approximately 15 months)
Program adherence will be monitored through participant-led tracking tools, periodic communications with the exercise professional, review of exercise and activity logs completed by participants (including exercise type, frequency, and perceived exertion), and use of Fitbit activity trackers (caregivers only). Adherence will be defined as the completion of at least ≥ 70% of the intervention components, including aerobic and resistance exercise, engagement with nutritional counselling, and participation in stress reduction strategies.
Safety Assessed Via Self-Reported Adverse Events
时间窗: During the study intervention period (approximately 15 months)
Safety will be assessed via self-reported adverse events documented in exercise logs and verified during weekly virtual check-ins. Participants will be explicitly instructed to report any adverse events immediately, even outside scheduled sessions, to ensure timely assessment and response by the research team
Participant Retention in the Study According to Research Team Records
时间窗: Over the study data collection period (approximately 15 months)
Participant retention will be assessed by measuring participant follow-up throughout the study period, according to research team records. A retention rate of 80% or greater (in each group) has been established as the criteria to determine study feasibility.
Satisfaction Questionnaire (Intervention Group Only)
时间窗: After the 8-week intervention period.
Participant satisfaction and barriers to engagement in the intervention will be determined using a satisfaction questionnaire.
次要结局
- Stress Assessed by Perceived Stress Scale (All Caregivers and Patients)(Change from baseline at 4 and 8 weeks after intervention start.)
- Advanced Care Planning Assessed by Preparedness for Caregivers Scale (Caregiver Arms Only)(Change from baseline at 4 and 8 weeks after intervention start.)
- Health-Related Quality of Life Assessed by Short-Form 36 Questionnaire (All Caregivers and Patients)(Change from baseline at 4 and 8 weeks after intervention start.)
- Mood Assessed by Depression, Anxiety, and Stress Scale (All Caregivers and Patients)(Change from baseline at 4 and 8 weeks after intervention start.)
- Nutrition Assessed by Rapid Eating Assessment for Participants (Caregiver Arms Only)(Change from baseline at 4 and 8 weeks after intervention start.)
- Physical Activity and Exercise Behaviors Assessed by International Physical Activity Questionnaire (Caregiver Arms Only)(Change from baseline at 4 and 8 weeks after intervention start.)
- Physical Activity Levels Assessed by Fitbit Device (Caregiver Arms Only)(Over the 8-week study period (from randomization to end of study period))