VR-Guided Mindfulness for ESKD Caregiver Well-Being
30 participantsStarted 2024-08-01
Plain-language summary
This pilot randomized controlled trial aims to evaluate the efficacy and feasibility of a virtual reality (VR)-guided mindfulness intervention for caregivers of patients with end-stage kidney disease (ESKD). Thirty ESKD caregivers will be randomly assigned to either a 6-week VR-guided mindfulness intervention or a sham VR control group. The study will assess changes in caregiver burden, stress, anxiety, depression, quality of life, and mindfulness using validated questionnaires. Feasibility outcomes, including recruitment, retention, adherence, and participant experiences, will also be evaluated. The findings will inform the design of a future larger-scale trial and may lead to the development of an accessible, technology-based support option for ESKD caregivers.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 21 years or older
* Primary caregiver of a patient with end-stage kidney disease (ESKD) (stage 4 \& 5 with - estimated glomerular filtration rate \< 30 mL/min/1.73 m²)
* Proficient in English
Exclusion Criteria:
* Known visual or hearing impairments
* History of motion sickness
* Active psychosis or suicidal ideation
* Current regular mindfulness practice
* History of seizure, stroke, or head injury
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is still listed as 'not yet recruiting' — do you know when it might open for enrollment, and would it even make sense for me to get on a waitlist now given where we are in our care situation?
2The study is specifically measuring changes in caregiver burden for people supporting someone with end-stage kidney disease — do you think the level of stress and caregiving demands I'm experiencing right now matches what this trial seems to be designed for?
3Since this is a Phase NA study using VR-guided mindfulness, which suggests it may be in early exploratory stages, what is actually known so far about whether virtual reality mindfulness tools are safe and genuinely helpful for caregivers, versus this being a largely untested approach?
4Are there existing caregiver support programs, counseling services, or mindfulness resources available to me right now that don't require waiting for a trial to open, so I have some support in the meantime?
5Given that this trial focuses entirely on caregiver well-being rather than the patient's kidney disease treatment, how would participating in something like this fit alongside everything else we're already managing with the medical care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Caregiver Burden
Timeframe: Baseline to 6 weeks (post-intervention)