Well-being Program for Caregivers of Patients With Advanced Cardiac and Pulmonary Disease

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.

Primary Objective 1: To evaluate the feasibility of delivering an 8-week, individualized, home-based wellness program for caregivers of people with advanced heart or lung disease who are receiving outpatient palliative care.

Measurement 1: Feasibility will be assessed by looking at how many people are recruited and agree to participate, how many caregivers complete at least 70% of the program activities, how many remain in the study at 8 weeks, whether any safety concerns or serious side effects occur, and how satisfied participants are with the program (measured through questionnaires).

Secondary Objective 1: To assess early indications of whether the program may improve caregivers' health-related quality of life, physical function, and psychological well-being (including anxiety, depression, and perceived stress), as well as the quality of the caregiver-patient relationship.

Measurement 1: Changes from the start of the study to weeks 4 and 8 will be assessed using validated questionnaires, including the Short-Form 36 (SF-36), the Depression Anxiety Stress Scale (DASS-21), the Perceived Stress Scale (PSS), and the Preparation for Caregiving Scale.

Secondary Objective 2: To explore caregiver and patient experiences with the program.

Measurement 2: Optional semi-structured interviews will be conducted with caregivers and, if they agree, with patients, at flexible time points-before the program starts, during the 8-week intervention, or up to 4 weeks after the program is finished.

This study will determine if a virtual caregiver wellness program is feasible and safe. If successful, it will fill a major gap in care by directly supporting caregivers, who are often overlooked. The anticipated benefits include reduced caregiver stress, improved quality of life, and stronger caregiver-patient relationships. In the long term, caregiver well-being may also improve patient outcomes and reduce healthcare burden.

• Health-Related Quality of Life Assessed by Short-Form 36 Questionnaire (All Caregivers and Patients) [Срок оценки: Change from baseline at 4 and 8 weeks after intervention start.]
• Mood Assessed by Depression, Anxiety, and Stress Scale (All Caregivers and Patients) [Срок оценки: Change from baseline at 4 and 8 weeks after intervention start.]
• Stress Assessed by Perceived Stress Scale (All Caregivers and Patients) [Срок оценки: Change from baseline at 4 and 8 weeks after intervention start.]
• Advanced Care Planning Assessed by Preparedness for Caregivers Scale (Caregiver Arms Only) [Срок оценки: Change from baseline at 4 and 8 weeks after intervention start.]
• Nutrition Assessed by Rapid Eating Assessment for Participants (Caregiver Arms Only) [Срок оценки: 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) [Срок оценки: Change from baseline at 4 and 8 weeks after intervention start.]
• Physical Activity Levels Assessed by Fitbit Device (Caregiver Arms Only) [Срок оценки: Over the 8-week study period (from randomization to end of study period)]