Authors
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University Health Network, Toronto -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
Caregivers of people with advanced cardiac or pulmonary disease play a critical role insupporting 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, lowerphysical activity, sleep disruption, and worse quality of life among caregivers. Overtime, these challenges can negatively impact both the caregiver's own health and theirability to continue providing support.Most existing wellness or rehabilitation programs focus on the patient rather than thecaregiver. As a result, caregivers have limited access to structured support designedspecifically for their own health needs. Previous research in patients with advanceddisease and transplant recipients has shown that virtual programs combining exercise,nutrition counselling, and stress management are feasible, safe, and acceptable. Theseprograms were able to improve aspects of physical and emotional well‐being, demonstratingthat remotely delivered interventions can be effective in populations with significanthealth challenges.Given this evidence, it is important to extend support directly to caregivers, who areoften overlooked despite being at high risk for stress‐related health problems.Addressing this gap has the potential to improve both caregiver outcomes and the carethey provide to patients.The investigators are testing a flexible, home‐based wellness program designed to supportthe physical and emotional well‐being of caregivers of people living with serious heartor 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 inthe future. This study will also look at how the program affects caregivers' quality oflife, 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 an8‐week, home‐based wellness program and whether caregivers can safely participate in theintervention. The investigators expect that caregivers will find the program acceptableand that it will be possible to deliver physical activity, nutrition counselling, andstress management strategies in a virtual format. In addition, the study will explorepreliminary signals of benefit, including improvements in caregiver quality of life,stress, and psychosocial well‐being. Finally, exploratory qualitative interviews willexamine whether supporting caregivers in this way may also influence patient experiencesand 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 diseasewho are receiving outpatient palliative care.Measurement 1: Feasibility will be assessed by looking at how many people are recruitedand agree to participate, how many caregivers complete at least 70% of the programactivities, how many remain in the study at 8 weeks, whether any safety concerns orserious side effects occur, and how satisfied participants are with the program (measuredthrough questionnaires).Secondary Objective 1: To assess early indications of whether the program may improvecaregivers' health‐related quality of life, physical function, and psychologicalwell‐being (including anxiety, depression, and perceived stress), as well as the qualityof the caregiver‐patient relationship.Measurement 1: Changes from the start of the study to weeks 4 and 8 will be assessedusing validated questionnaires, including the Short‐Form 36 (SF‐36), the DepressionAnxiety Stress Scale (DASS‐21), the Perceived Stress Scale (PSS), and the Preparation forCaregiving 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, duringthe 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, whoare often overlooked. The anticipated benefits include reduced caregiver stress, improvedquality of life, and stronger caregiver‐patient relationships. In the long term,caregiver well‐being may also improve patient outcomes and reduce healthcare burden.
Epistemonikos ID: a639e9ec95a86b719a22af40c637abee2549cac6
First added on: Jul 07, 2026