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

NCT07685912 | Not Yet Recruiting

• 1 other identifier: 25-5623
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Nutrition; Stress management; Well-being

Outcome Measures

Primary Outcomes (6)

• Study Recruitment According to Research Team Records

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

  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.

  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.

  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

  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.

  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.

  After the 8-week intervention period.

Secondary Outcomes (7)

• 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.

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

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

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

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

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

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

• Nutrition Assessed by Rapid Eating Assessment for Participants (Caregiver Arms Only)

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

Other Outcomes (1)

• Qualitative Interview (Optional)

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

Study Arms (3)

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.

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.

Interventions

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.

Multimodal Caregiver Well-being Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Diagnosis of advanced cardiac or pulmonary disease and currently receiving outpatient palliative care at Toronto General Hospital
• Ability to provide informed consent
• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (8)

• 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.

  PMID: 27617564 BACKGROUND

• Ullrich 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.

  PMID: 15689302 BACKGROUND

• Rodrigue 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.

  PMID: 17988265 BACKGROUND

• Myaskovsky 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.

  PMID: 15748679 BACKGROUND

• Miravitlles 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.

  PMID: 25709429 BACKGROUND

• Suksatan 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.

  PMID: 35938489 BACKGROUND

• Krug 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.

  PMID: 26767785 BACKGROUND

• Semere 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.

  PMID: 33478890 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Lung Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Respiratory Tract Diseases; Behavior

Central Study Contacts

Dmitry Rozenberg, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre, open-label, parallel-arm feasibility randomized controlled trial (RCT)

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)