Cardiac Disease, Caregiver, Pulmonary Diseases
Conditions
Keywords
Exercise, Nutrition, Stress management, Well-being
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMultimodal Well-being Program
The multimodal caregiver wellness Program includes three core components: flexible physical activity or exercise program tailored to the goals of caregivers, nutritional counselling, and stress management strategies delivered through the exercise professional and registered dietician. Participants will be encouraged to engage in aerobic exercise, with a goal of gradually increasing activity levels toward guideline-based targets, complemented by resistance training or other preferred forms of physical activity. The nutritional component includes one individualized 45-60-minute counselling session with a registered dietitian, based on a brief nutrition screening tool tailored to the caregiver's health needs. Participants may request follow-up support throughout the intervention period. Stress management is embedded based on participant availability, interactions with the exercise professional, and focusing on integrating simple stress-reduction strategies into daily routines.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single-centre, open-label, parallel-arm feasibility randomized controlled trial (RCT)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(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
Exclusion criteria
(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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Recruitment According to Research Team Records | 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 | 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) | 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 | 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 | 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) | After the 8-week intervention period. | Participant satisfaction and barriers to engagement in the intervention will be determined using a satisfaction questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Health-related Quality of Life (HRQL) will be assessed through the Short-Form 36 (SF-36) Questionnaire. This generic health instrument is widely employed and comprises 8 health domains and two summary scores (physical and mental) ranging from 0 to 100, with higher scores indicating better HRQL. It assesses quality of life and has normative values of 50, with a minimal important difference (MID) of 5 points. |
| Mood Assessed by Depression, Anxiety, and Stress Scale (All Caregivers and Patients) | Change from baseline at 4 and 8 weeks after intervention start. | The Depression, Anxiety and Stress Scale (DASS-21) questionnaire has 21 items to assess mood (anxiety, depression, and stress). Each statement is given a score of 0 (not applicable) to 3 (applicable most of the time), with a sub-score calculated for each domain as the sum of individual scores, ranging from 0-42 with higher scores indicating worse mood disturbances. Sub-scores are then categorized as follows: Normal, Mild, Moderate, Severe, and Extremely Severe. |
| Stress Assessed by Perceived Stress Scale (All Caregivers and Patients) | Change from baseline at 4 and 8 weeks after intervention start. | Stress will be assessed using the Perceived Stress Scale. This is a commonly used tool for assessing psychological stress, measuring the degree to which life situations are unpredictable or overwhelming. Scores range from 0 to 40, with higher scores indicating increased stress |
| Advanced Care Planning Assessed by Preparedness for Caregivers Scale (Caregiver Arms Only) | Change from baseline at 4 and 8 weeks after intervention start. | Caregiver readiness to handle the caregiving role will be assessed by the Preparedness for Caregivers Scale. This is a brief self-report tool used to assess how well informal caregivers feel prepared to provide care across multiple domains, including physical and emotional support, managing stress, and navigating healthcare systems. It consists of 8 items rated on a scale from 0 (not at all prepared) to 4 (very well prepared). The final score is the mean of all items answered, ranging from 0 to 4, with higher scores indicating greater perceived preparedness for caregiving. |
| Nutrition Assessed by Rapid Eating Assessment for Participants (Caregiver Arms Only) | Change from baseline at 4 and 8 weeks after intervention start. | The Rapid Eating Assessment for Participants (REAP) will be administered to assess participants' dietary habits and guide nutrition counselling. The first 13 questions are scored on a scale from 1 to 3 points based on how often a behavior occurs, resulting in a total score between 13 and 39. Higher scores mean a person has healthier eating habits, with a score of 32 or above generally showing a high-quality diet. The final three questions help providers understand the person's willingness and barriers to making healthy food changes. |
| 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. | The International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be used to measure physical activity levels in study participants. The questionnaire consists of seven questions to capture average daily time spent sitting, walking, and engaging in moderate and vigorous physical activity over the last seven days. The IPAQ-SF provides an overall physical activity level of participants based on their Metabolic Equivalent Task minutes per week, with a higher score indicating a higher activity level. |
| Physical Activity Levels Assessed by Fitbit Device (Caregiver Arms Only) | Over the 8-week study period (from randomization to end of study period) | Participants' physical activity levels will be assessed by tracking the number of daily steps continuously over the 8-week study period using a Fitbit device, with more steps indicating higher physical activity levels. Participants will also be encouraged to "start" and "stop" activities on the Fitbit when possible to improve accuracy of activity tracking. |
Countries
Canada
Contacts
CONTACTDmitry Rozenberg, MD, PhD
Outcome results
None listed