CaregiverNCT07685912
Well-being Program for Caregivers of Patients With Advanced Cardiac and Pulmonary Disease
A study testing Multimodal Well-being Program in people with Caregiver and Cardiac Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver, Cardiac Disease, Pulmonary Diseases
- What is being tested?
- Multimodal Well-being Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Dmitry Rozenberg, MD, PhD, 416-340-4800 ext. 7358, dmitry.rozenberg@uhn.ca
About this study
Official title: Enhancing Caregiver Wellbeing: The Role of Exercise, Nutrition, and Stress Management for Caregivers of Patients With Advanced Cardiac and Pulmonary Disease
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.
Read the 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.
- Conditions
- Caregiver, Cardiac Disease, Pulmonary Diseases
- Being tested
- Multimodal Well-being Program
- Keywords
- Exercise, Nutrition, Stress management, Well-being
- Medical subject headings
- Heart Diseases, Lung Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Well-being ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Caregiver Well-being Intervention | Experimental | 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. Receives: Behavioral: Multimodal Well-being Program |
| Usual care | No intervention | 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) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Recruitment According to Research Team Records
Recruitment-success percentage in the study will be assessed based on research team study records.
Measured: Over study recruitment period (approximately 15 months)
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.
Measured: Over study recruitment period (approximately 15 months)
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.
Measured: During the study intervention period (approximately 15 months)
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
Measured: During the study intervention period (approximately 15 months)
Participant Retention in the Study According to Research Team Records
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.
Measured: Over the study data collection period (approximately 15 months)
Satisfaction Questionnaire (Intervention Group Only)
Participant satisfaction and barriers to engagement in the intervention will be determined using a satisfaction questionnaire.
Measured: After the 8-week intervention period.
Secondary outcomes (7)
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.
Measured: Change from baseline at 4 and 8 weeks after intervention start.
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.
Measured: Change from baseline at 4 and 8 weeks after intervention start.
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
Measured: Change from baseline at 4 and 8 weeks after intervention start.
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.
Measured: Change from baseline at 4 and 8 weeks after intervention start.
Nutrition Assessed by Rapid Eating Assessment for Participants (Caregiver Arms Only)
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.
Measured: 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)
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.
Measured: Change from baseline at 4 and 8 weeks after intervention start.
Physical Activity Levels Assessed by Fitbit Device (Caregiver Arms Only)
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.
Measured: Over the 8-week study period (from randomization to end of study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Nov 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, open-label, parallel-arm feasibility randomized controlled trial (RCT)
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685912
- Sponsor's protocol ID
- 25-5623
- Status last verified
- Nov 2026
- First submitted
- 29 Jun 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bidwell JT, Lyons KS, Lee CS. Caregiver Well-being and Patient Outcomes in Heart Failure: A Meta-analysis. J Cardiovasc Nurs. 2017 Jul/Aug;32(4):372-382. doi: 10.1097/JCN.0000000000000350.
PubMed 27617564Ullrich G, Jansch H, Schmidt S, Struber M, Niedermeyer J. The experience of the support person involved in a lung transplant programme: results of a pilot study. Eur J Med Res. 2004 Dec 22;9(12):555-652.
PubMed 15689302Rodrigue JR, Baz MA. Waiting for lung transplantation: quality of life, mood, caregiving strain and benefit, and social intimacy of spouses. Clin Transplant. 2007 Nov-Dec;21(6):722-7. doi: 10.1111/j.1399-0012.2007.00729.x.
PubMed 17988265Myaskovsky L, Dew MA, Switzer GE, McNulty ML, DiMartini AF, McCurry KR. Quality of life and coping strategies among lung transplant candidates and their family caregivers. Soc Sci Med. 2005 May;60(10):2321-32. doi: 10.1016/j.socscimed.2004.10.001. Epub 2004 Dec 15.
PubMed 15748679Miravitlles M, Pena-Longobardo LM, Oliva-Moreno J, Hidalgo-Vega A. Caregivers' burden in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2015 Feb 12;10:347-56. doi: 10.2147/COPD.S76091. eCollection 2015.
PubMed 25709429Suksatan W, Tankumpuan T, Davidson PM. Heart Failure Caregiver Burden and Outcomes: A Systematic Review. J Prim Care Community Health. 2022 Jan-Dec;13:21501319221112584. doi: 10.1177/21501319221112584.
PubMed 35938489Krug K, Miksch A, Peters-Klimm F, Engeser P, Szecsenyi J. Correlation between patient quality of life in palliative care and burden of their family caregivers: a prospective observational cohort study. BMC Palliat Care. 2016 Jan 15;15:4. doi: 10.1186/s12904-016-0082-y.
PubMed 26767785Semere W, Althouse AD, Rosland AM, White D, Arnold R, Chu E, Smith TJ, Schenker Y. Poor patient health is associated with higher caregiver burden for older adults with advanced cancer. J Geriatr Oncol. 2021 Jun;12(5):771-778. doi: 10.1016/j.jgo.2021.01.002. Epub 2021 Jan 18.
PubMed 33478890
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Caregiver Wellbeing: The Role of Exercise, Nutrition, and Stress Management for Caregivers of Patients With Advanced Cardiac and Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07685912
- Acronym / sponsor ID
- 25-5623
- Conditions
- Caregiver, Cardiac Disease, Pulmonary Diseases
- Keywords
- Exercise, Nutrition, Stress management, Well-being
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Nov 2026 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single-centre, open-label, parallel-arm feasibility randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Multimodal Caregiver Well-being Intervention | Experimental | Behavioral: Multimodal Well-being ProgramThe 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. |
| Usual care | No intervention | –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) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Aged 18 years or older
- Diagnosis of advanced cardiac or pulmonary disease and currently receiving outpatient palliative care at Toronto General Hospital
Key exclusion criteria (6 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Well-being ProgramThe 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. | Behavioural | Multimodal Caregiver Well-being Intervention |
Primary outcome
Study Recruitment According to Research Team Records
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: After the 8-week intervention period.
Participant satisfaction and barriers to engagement in the intervention will be determined using a satisfaction questionnaire.
7 secondary outcomes
Health-Related Quality of Life Assessed by Short-Form 36 Questionnaire (All Caregivers and Patients)
Time frame: Change from baseline at 4 and 8 weeks after intervention start.
Mood Assessed by Depression, Anxiety, and Stress Scale (All Caregivers and Patients)
Time frame: Change from baseline at 4 and 8 weeks after intervention start.
Stress Assessed by Perceived Stress Scale (All Caregivers and Patients)
Time frame: Change from baseline at 4 and 8 weeks after intervention start.
Advanced Care Planning Assessed by Preparedness for Caregivers Scale (Caregiver Arms Only)
Time frame: Change from baseline at 4 and 8 weeks after intervention start.
Nutrition Assessed by Rapid Eating Assessment for Participants (Caregiver Arms Only)
Time frame: 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)
Time frame: Change from baseline at 4 and 8 weeks after intervention start.
Physical Activity Levels Assessed by Fitbit Device (Caregiver Arms Only)
Time frame: Over the 8-week study period (from randomization to end of study period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 27617564Bidwell JT, Lyons KS, Lee CS. Caregiver Well-being and Patient Outcomes in Heart Failure: A Meta-analysis. J Cardiovasc Nurs. 2017 Jul/Aug;32(4):372-382. doi: 10.1097/JCN.0000000000000350.
- Background: PubMed 15689302Ullrich G, Jansch H, Schmidt S, Struber M, Niedermeyer J. The experience of the support person involved in a lung transplant programme: results of a pilot study. Eur J Med Res. 2004 Dec 22;9(12):555-652.
- Background: PubMed 17988265Rodrigue JR, Baz MA. Waiting for lung transplantation: quality of life, mood, caregiving strain and benefit, and social intimacy of spouses. Clin Transplant. 2007 Nov-Dec;21(6):722-7. doi: 10.1111/j.1399-0012.2007.00729.x.
- Background: PubMed 15748679Myaskovsky L, Dew MA, Switzer GE, McNulty ML, DiMartini AF, McCurry KR. Quality of life and coping strategies among lung transplant candidates and their family caregivers. Soc Sci Med. 2005 May;60(10):2321-32. doi: 10.1016/j.socscimed.2004.10.001. Epub 2004 Dec 15.
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- Background: PubMed 35938489Suksatan W, Tankumpuan T, Davidson PM. Heart Failure Caregiver Burden and Outcomes: A Systematic Review. J Prim Care Community Health. 2022 Jan-Dec;13:21501319221112584. doi: 10.1177/21501319221112584.
- Background: PubMed 26767785Krug K, Miksch A, Peters-Klimm F, Engeser P, Szecsenyi J. Correlation between patient quality of life in palliative care and burden of their family caregivers: a prospective observational cohort study. BMC Palliat Care. 2016 Jan 15;15:4. doi: 10.1186/s12904-016-0082-y.
- Background: PubMed 33478890Semere W, Althouse AD, Rosland AM, White D, Arnold R, Chu E, Smith TJ, Schenker Y. Poor patient health is associated with higher caregiver burden for older adults with advanced cancer. J Geriatr Oncol. 2021 Jun;12(5):771-778. doi: 10.1016/j.jgo.2021.01.002. Epub 2021 Jan 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Well-being Program in people with Caregiver and Cardiac Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Rozenberg, MD, PhD (416-340-4800 ext. 7358, Dmitry.Rozenberg@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Recruitment According to Research Team Records (time frame: Over study recruitment period (approximately 15 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07685912, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.