About this trial

The goal of this randomized feasibility clinical trial is to identify participant recruitment and retention, acceptability, and adherence to virtual reality training in people undergoing hemodialysis. The main question it aims to answer is if virtual reality could be a feasible and acceptable intervention in this setting.

The investigators will compare participants on virtual reality training during the standard dialysis session with those treated with standard dialysis session alone to see if a cognitive training using immersive virtual reality in people on hemodialysis is feasible and acceptable.

Participants randomised in the intervention group will use virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks. The virtual reality intervention will consist of computerized cognitive training of 4 games. Each exercise delivered to the participant will specifically provide training in a specific cognitive category (memory, cognitive flexibility, processing, attention, and memory). Participants randomised in the control group will perform the standard hemodialysis session three times a week for 12 weeks, without using virtual reality.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult participants aged 18 years or older and less than or equal to 75 years of age

Receiving haemodialysis treatment for kidney failure for at least 90 days (permanent reduction in kidney function below an estimated glomerular filtration rate of 15 mL/minute per 1.73 m2)

Able to provide written and informed consent

Able to use the immersive virtual reality headset and follow instructions with sufficient motor, visual and auditory function to interact with the intervention

Disqualifiers

Severe cognitive impairment or psychiatric diseases leading to inability to follow instructions and use the virtual reality headset

Significant nystagmus and/or vertigo leading to inability to tolerate the virtual reality headset

Insufficient motor function to use the virtual reality system

Hearing or visual disability

Trial design

Design model

Parallel

Treatments tested in this trial

Virtual reality platform on head mounted display
Device
Enhance Virtual Reality platform on a Meta Quest head mounted display

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Virtual realityActive comparator 1 intervention

Group B: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Accept the invitation to participate

Proportion of screened patients who participate in one or more sessions of allocated virtual reality training.

Time frame

4, 12 weeks

2

Appropriateness of eligibility criteria

Recruitment rate during 12 weeks of recruitment phase.

Time frame

12 weeks

3

Retention

Proportion of randomized participants who complete the intervention and complete follow-up at 12 weeks.

Time frame

12 weeks

4

Acceptability

Proportion of randomized participants who complete \>80% of the treatments during 12 weeks follow-up.

Time frame

12 weeks

Secondary outcomes

1

Depression

Proportion of randomized participants who complete the outcome measurements using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided in two seven-item subscales. The total score for each subscale ranges from 0 to 21. In general a score ≤7 corresponds to "no depression or anxiety," a score of 8-10 is a minor depression/anxiety, a score of 11-15 a moderate depression/anxiety and a score ≥16 is defined as severe depression/anxiety.

Time frame

0, 4, 12, 24 weeks

2

Anxiety

Proportion of randomized participants who complete the outcome measurements using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided in two seven-item subscales. The total score for each subscale ranges from 0 to 21. In general a score ≤7 corresponds to "no depression or anxiety," a score of 8-10 is a minor depression/anxiety, a score of 11-15 a moderate depression/anxiety and a score ≥16 is defined as severe depression/anxiety.

Time frame

0, 4, 12, 24 weeks

3

Quality of life

Proportion of randomized participants who complete the outcome measurements using the 5-level EQ-5D version (EQ-5D-5L). In the EQ-5D-5L scores range from 0 to 100, where 100 is the best possible health related quality of life.

Time frame

0, 4, 12, 24 weeks

4

Fatigue

Proportion of randomized participants who complete the outcome measurements using the Kidney Disease Quality of Life Short Form 36 (KDQOL-36). The KDQOL-36 has five scales, including two generic health related quality of life scales from the SF-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each of the KDQOL-36 kidney-targeted scales are scored by transforming all items linearly to a 0-100 possible range and averaging the items in the scale. On the KDQOL-36, higher scores indicate better outcome.

Time frame

0, 4, 12, 24 weeks

Virtual Reality for Cognitive Impairment in Hemodialysis

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts