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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Aged 18 years or older

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multimodal Well-being Program

    Behavioral

    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.

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Multimodal Caregiver Well-being InterventionExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Group C: Patients (Optional)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Study Recruitment According to Research Team Records

Recruitment-success percentage in the study will be assessed based on research team study records.

Time frame
Over study recruitment period (approximately 15 months)
2

Study Consent Rates According to Research Team Records

Consent-success percentage in the study and reasons for declining participation will be assessed based on research team study records.

Time frame
Over study recruitment period (approximately 15 months)
3

Self-Reported Adherence to Multimodal Well-being Program According to Participant Logs (Intervention Group Only)

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.

Time frame
During the study intervention period (approximately 15 months)
4

Safety Assessed Via Self-Reported Adverse Events

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

Time frame
During the study intervention period (approximately 15 months)

Secondary outcomes

1

Health-Related Quality of Life Assessed by Short-Form 36 Questionnaire (All Caregivers and Patients)

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.

Time frame
Change from baseline at 4 and 8 weeks after intervention start.
2

Mood Assessed by Depression, Anxiety, and Stress Scale (All Caregivers and Patients)

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.

Time frame
Change from baseline at 4 and 8 weeks after intervention start.
3

Stress Assessed by Perceived Stress Scale (All Caregivers and Patients)

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

Time frame
Change from baseline at 4 and 8 weeks after intervention start.
4

Advanced Care Planning Assessed by Preparedness for Caregivers Scale (Caregiver Arms Only)

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.

Time frame
Change from baseline at 4 and 8 weeks after intervention start.

Other outcomes

1

Qualitative Interview (Optional)

A subset of caregiver and patient participants will be invited to participate in an optional qualitative semi-structured interview at flexible time points before, during, or up to approximately 4 weeks after the study period.

Time frame
Before, during, or up to approximately 4 weeks after the study period.

Sponsors and contacts

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