VR-Guided Mindfulness for ESKD Caregiver Well-Being
NCT Number: NCT06479200
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Kidney Failure, Chronic
Interventions: BEHAVIORAL: VR-guided mindfulness|OTHER: Sham VR
Sponsor: Alexandra Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2025-08-01

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.

Primary Outcome Measures: Change in Caregiver Burden, Change in caregiver burden as measured by the Zarit Burden Interview (ZBI). The ZBI is a validated 22-item questionnaire that assesses the level of burden experienced by caregivers. Scores range from 0 to 88, with higher scores indicating greater caregiver burden., Baseline to 6 weeks (post-intervention)
Secondary Outcome Measures: Change in Stress, anxiety, and depression, Change in stress, anxiety, and depression levels as measured by the Depression Anxiety Stress Scale-21 (DASS-21). The DASS-21 is a 21-item self-report questionnaire that measures the negative emotional states of depression, anxiety, and stress. Each subscale (Stress, Anxiety, Depression) consists of 7 items, scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time).

Measure: Total score on the Depression Anxiety Stress Scale-21 (DASS-21) Unit of Measure: Points on a scale from 0 to 63 Direction: Lower scores indicate better outcome, Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)|Change in Quality of Life, Change in quality of life as measured by the Kidney Disease Quality of Life Short Form (KDQOL-SF). The KDQOL-SF is a kidney disease-specific measure of health-related quality of life that includes the SF-36 as generic core plus items about kidney disease.

Measure: Overall score on the Kidney Disease Quality of Life Short Form (KDQOL-SF) Unit of Measure: Points on a scale from 0 to 100 Direction: Higher scores indicate better outcome, Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)|Change in Mindfulness, Change in mindfulness as measured by the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ is a 39-item questionnaire that assesses five facets of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.

Measure: Total score on the Five Facet Mindfulness Questionnaire (FFMQ) Unit of Measure: Points on a scale from 39 to 195 Direction: Higher scores indicate better outcome (greater mindfulness), Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)|Accrual rate, The proportion of eligible caregivers who agree to participate in the study out of the total number of eligible caregivers approached.

Measure: Number of participants enrolled divided by the number of eligible caregivers approached Unit of Measure: Percent, Throughout the study period (12 weeks)|Retention rate, The proportion of enrolled participants who complete the study, including post-intervention (6 weeks) and follow-up (12 weeks) assessments.

Measure: Number of participants completing the final follow-up assessment divided by the total number of participants enrolled Unit of Measure: Percent, Throughout the study period (12 weeks)|Adherence rate, The proportion of participants who complete at least 80% of the prescribed VR sessions (29 out of 36 sessions over 6 weeks).

Measure: Number of participants completing at least 29 VR sessions divided by the total number of participants in the intervention group Unit of Measure: Percent, Throughout the study period (12 weeks)|Questionnaire completion rate, The proportion of participants who complete all outcome questionnaires (ZBI, DASS-21, KDQOL-SF, and FFMQ) at each assessment time point (baseline, 6 weeks, and 12 weeks).

Measure: Number of participants completing all questionnaires at all time points divided by the total number of enrolled participants Unit of Measure: Percent, Throughout the study period (12 weeks)|side effect rate, The proportion of participants who report any adverse effects related to VR use (e.g., motion sickness, eye strain, headaches) throughout the study period.

Measure: Number of participants reporting at least one side effect divided by the total number of participants using VR (both intervention and control groups) Unit of Measure: Percent, Throughout the study period (12 weeks)|Participant Satisfaction, Assessment of participant satisfaction with the VR-guided mindfulness intervention using the Client Satisfaction Questionnaire-8 (CSQ-8). Measure: Total score on the CSQ-8 Unit of Measure: Points on a scale from 8 to 32, 6 weeks (post-intervention)