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Clinical Trial NCT06739187 (VIRTUAL) for Hemodialysis is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Virtual Reality for Cognitive Impairment in Hemodialysis (VIRTUAL) Phase 2 60 Randomized Exercise-Based Virtual
Clinical Trial NCT06739187 (VIRTUAL) is designed to study Treatment for Hemodialysis. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2025 until the study accrues 60 participants. Led by University of Campania Luigi Vanvitelli, this study is expected to complete by 1 April 2026. The latest data from ClinicalTrials.gov was last updated on 18 December 2024.
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 dia...
Show MoreDetailed Description
The trial is a multicenter, parallel group, feasibility randomized controlled trial.
The trial population will include adult participants, who have the physical and cognitive capacity to be trained using immersive virtual reality and who have kidney failure on hemodialysis.
Participants will be allocated in the intervention (virtual reality session) or standard of care without the intervention. Participants will be...
Show MoreOfficial Title
Virtual Reality Training for Cognitive Impairment in Adults Treated With Hemodialysis: A Feasibility Randomized Controlled Trial
Conditions
HemodialysisOther Study IDs
- VIRTUAL
- PRIN20225JEHW8
- PRIN20225JEHW8 (Other Grant/Funding Number) (PRIN 2022)
NCT ID Number
Start Date (Actual)
2025-04-01
Last Update Posted
2024-12-18
Completion Date (Estimated)
2026-04-01
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
hemodialysis
virtual reality
RCT
kidney failure
virtual reality
RCT
kidney failure
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorVirtual reality Participants will use the virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks. | Virtual reality platform on head mounted display Enhance Virtual Reality platform on a Meta Quest head mounted display |
No InterventionStandard care Participants will perform the standard dialysis session three times a week for 12 weeks without virtual reality training sessions. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 0, 4, 12, 24 weeks |
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. | 0, 4, 12, 24 weeks |
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. | 0, 4, 12, 24 weeks |
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. | 0, 4, 12, 24 weeks |
Health utility | Proportion of randomized participants who complete an authors' designed questionnaire | 0 and 12 weeks |
All-cause death | All-cause death reported during the study | 12 weeks |
Cardiovascular events | All cardiovascular events (myocardial infarction, stroke, peripheral arterial event) reported during the study | 12 weeks |
Pulse | Pulse rate (bpm) | 0 and 12 weeks |
Systolic blood pressure | Systolic blood pressure (mmHg) | 0 and 12 weeks |
Diastolic blood pressure | Diastolic blood pressure (mmHg) | 0 and 12 weeks |
Functional near-infrared spectroscopy | Functional near-infrared spectroscopy (fNIR) | 0 and 12 weeks |
Kt/V | Kt/V | 0 and 12 weeks |
Dialysis duration | Dialysis duration (min) | 0 and 12 weeks |
Type of dialysis | Type of dialysis | 0 and 12 weeks |
Hemoglobin | Hemoglobin (g/dL) | 0 and 12 weeks |
Glucose | Glucose (mg/dL) | 0 and 12 weeks |
Glycated hemoglobin | HbA1c (%) | 0 and 12 weeks |
Serum creatinine | Serum creatinine (mg/dL) | 0 and 12 weeks |
Serum albumin | Serum albumin (g/dL) | 0 and 12 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
University of Campania Luigi Vanvitelli- 🎓University of ...
Study Responsible Party
Davide Viggiano, Principal Investigator, Prof, University of Campania Luigi Vanvitelli
No contact data.
2 Study Locations in 1 Countries
BA
University of Bari, Bari, BA, 70124, Italy
Giovanni Strippoli, Prof, Contact, 0805591111, [email protected]
Univerity Vanvitelli, Naples, 80133, Italy
Davide Viggiano, Prof, Contact, 0815664282, [email protected]