Virtual Reality for Cognitive Impairment in Hemodialysis

NCT06739187 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PRIN20225JEHW8
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hemodialysis

Keywords

hemodialysis; virtual reality; RCT; kidney failure

Outcome Measures

Primary Outcomes (6)

• Accept the invitation to participate

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

  4, 12 weeks

• Appropriateness of eligibility criteria

  Recruitment rate during 12 weeks of recruitment phase.

  12 weeks

• Retention

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

  12 weeks

• Acceptability

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

  12 weeks

• Proportion of adverse events

  Proportion of randomized participants who have adverse event reporting completed at 12 weeks.

  12 weeks

• Quality of life

  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 health realated quality of life.

  0, 4, 12, 24 weeks

Secondary Outcomes (19)

• Depression

  0, 4, 12, 24 weeks

• Anxiety

  0, 4, 12, 24 weeks

• Quality of life

  0, 4, 12, 24 weeks

• Fatigue

  0, 4, 12, 24 weeks

• Health utility

  0 and 12 weeks

Study Arms (2)

Virtual reality

ACTIVE COMPARATOR

Participants will use the virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks.

Device: Virtual reality platform on head mounted display

Standard care

NO INTERVENTION

Participants will perform the standard dialysis session three times a week for 12 weeks without virtual reality training sessions.

Interventions

Virtual reality platform on head mounted display DEVICE

Enhance Virtual Reality platform on a Meta Quest head mounted display

Virtual reality

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to speak and understand Italian language

You may not qualify if:

• 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
• Advanced or uncompensated chronic diseases unrelated to kidney failure (e.g. advanced cancer, heart failure, lung diseases with poor oxygen saturation)
• Other neurological diseases (ictus, Alzheimer's or other forms of dementia)
• Persistent pain or itch or who using opioids that may interfere with the tests or any other condition that the clinician may judge as influencing the results

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• University of Sydney: collaborator
• University of Bari Aldo Moro: collaborator
• University of Otago: collaborator

Study Sites (2)

University of Bari

Bari, BA, 70124, Italy

Location

Univerity Vanvitelli

Naples, 80133, Italy

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 18, 2024
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)