Well-being Program for Caregivers

DR
Overseen ByDmitry Rozenberg, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an 8-week wellness program can help caregivers manage the stress and fatigue of supporting someone with advanced heart or lung disease. The Multimodal Well-being Program provides personalized advice on exercise, healthy eating, and stress management, all delivered virtually at home. Participants will have regular virtual check-ins with health professionals to ensure the program aligns with their needs and schedule. This trial suits unpaid caregivers who are the primary support for a patient with advanced heart or lung disease receiving outpatient care at Toronto General Hospital. As an unphased trial, it offers caregivers a unique opportunity to enhance their well-being through a personalized program.

What prior data suggests that this well-being program is safe for caregivers?

Research shows that wellness programs like the one under study for caregivers are generally safe. These programs include activities such as exercise, healthy eating, and stress management, which are not only safe but also commonly used to improve health and well-being.

Although specific safety data for the Multimodal Caregiver Well-being Program is not available, similar programs are usually well-received and have very few, if any, reported issues. The program's online format offers convenience and reduces risks compared to in-person activities.

While this trial is not in a traditional clinical phase, the program's nature suggests it is likely safe. Participation involves low-risk activities, and past research supports that these strategies help reduce stress and improve caregivers' quality of life.12345

Why are researchers excited about this trial?

Researchers are excited about the Multimodal Caregiver Well-being Intervention because it takes a holistic approach to support caregivers, offering a blend of physical exercise, nutritional counseling, and stress management, all personalized to individual needs. Unlike standard resources that primarily provide access to social support and information, this program actively engages caregivers in improving their own physical and mental health at home. By tailoring activities and advice to each caregiver's goals, this intervention aims to significantly enhance their overall well-being and resilience, which is particularly valuable given the demanding nature of caregiving.

What evidence suggests that this well-being program is effective for caregivers?

Research has shown that programs for caregivers can greatly reduce stress, depression, and anxiety. One study found that participants felt their quality of life improved after engaging in similar wellness activities. Another study discovered that these programs can lower distress and depressive symptoms in caregivers. These activities also help manage burnout and boost overall well-being. In this trial, participants in the Multimodal Caregiver Well-being Intervention arm will engage in an 8-week, individualized, home-based wellness program, which includes physical activity, nutritional counseling, and stress management strategies. Evidence supports that wellness programs designed for caregivers effectively enhance their mental and emotional health.56789

Are You a Good Fit for This Trial?

This trial is for adults who are caregivers of people with advanced heart or lung disease. Participants should be able to join virtual sessions from home and be willing to try a wellness program focused on their own health and well-being.

Inclusion Criteria

I have advanced heart or lung disease and get palliative care at Toronto General Hospital.
I am 18 years old or older.
Caregivers: Ability to provide informed consent
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Exclusion Criteria

Caregivers: Lack of access to a phone or internet connection to enable virtual participation
I do not have cognitive or language issues that prevent me from following study instructions.
I do not have cognitive or language issues that prevent me from following study instructions.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week, individualized, home-based wellness program including physical activity, nutrition counselling, and stress management strategies.

8 weeks
Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, including optional qualitative interviews.

4 weeks
Optional interviews

What Are the Treatments Tested in This Trial?

Interventions

  • Multimodal Well-being Program

Trial Overview

The study is testing an 8-week, at-home wellness program for caregivers. The program includes personalized plans for exercise, healthy eating, and stress management, supported by regular online check-ins with health professionals.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal Caregiver Well-being InterventionExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention
Group III: Patients (Optional)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

Health, Technology, and Caregiving Resources

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Effective Solutions for Caregivers of Older Adults - PMC - NIH

Caregiver interventions demonstrated statistically significant improvements in depression, particularly among interventions focused on MBI and ...

Changes in Health Indicators Among Caregivers

This report compares changes in the prevalence of 19 health indicators among caregivers and noncaregivers from 2015–2016 to 2021–2022.

Caregiver Well-Being | Memory and Aging Center - UCSF

Here are some strategies designed to help reduce the stress and burden of caregiving and foster effective coping, which may protect your health and well-being.

Well-being Program for Caregivers of Patients With ...

The multimodal caregiver wellness Program includes three core components: flexible physical activity or exercise program tailored to the goals ...

Well-being Program for Caregivers of... | Clinical Trial

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 ...

Family Caregiving Roles and Impacts - NCBI - NIH

This chapter examines the multiple and evolving roles of caregivers of older adults and the impact of assuming these roles on caregivers' health and well-being.

Caregiver Health

Higher levels of stress, anxiety, depression and other mental health effects are common among family members who care for an older relative or friend.