Recruiting

Wellness Program

Sponsor:

University Health Network, Toronto

Code:

NCT07685912

Conditions

Caregiver

Cardiac Disease

Pulmonary Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multimodal Well-being Program

Study Details

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.

Conditions

Caregiver

Cardiac Disease

Pulmonary Diseases

Study ID

NCT07685912

Start date

Nov 1, 2026

Status verified date

Nov, 2026

Completion date

Mar 30, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

no intervention: 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.

Interventions

Multimodal 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.

Primary outcome measure

  • Study Recruitment According to Research Team Records [ Time Frame: Over study recruitment period (approximately 15 months) ]
  • Study Consent Rates According to Research Team Records [ Time Frame: Over study recruitment period (approximately 15 months) ]
  • 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) ]
  • Safety Assessed Via Self-Reported Adverse Events [ Time Frame: During the study intervention period (approximately 15 months) ]
  • Participant Retention in the Study According to Research Team Records [ Time Frame: Over the study data collection period (approximately 15 months) ]
  • Satisfaction Questionnaire (Intervention Group Only) [ Time Frame: After the 8-week intervention period. ]

Central Contacts and Locations

Central contacts

Dmitry Rozenberg, MD, PhD

416-340-4800Dmitry.Rozenberg@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Dmitry Rozenberg, MD, PhD

416-340-4800dmitry.rozenberg@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Keywords

  • Exercise
  • Nutrition
  • Stress management
  • Well-being

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.