Hemophilia
Conditions
Keywords
Drug Therapy
Brief summary
The main aim is to describe how the treatment burden and challenges of participants, relatives, and doctors during regular Factor VIII and Factor IX infusions to treat hemophilia evolve using a virtual-reality (VR) based solution. The study also aims to find out how well the VR based solution is tolerated and how satisfied the participants, relatives, and doctors are with it. The VR-based solution includes a mobile phone app and a 3D mask. Participants will use the VR-based solution while receiving prophylactic Factor VIII and Factor IX infusions for 4 weeks at home. Participants will visit the clinic for the last infusion; at this time data will be collected from participants, relatives, and doctors
Interventions
DEVICEVirtual-reality (VR) Based Solution
VR-based solution comprises a mobile phone application including explanation on the different steps to be followed to perform infusions in satisfactory conditions, notably as regards safety, as well as VAS for pain and anxiety to be completed at each Factor VIII or Factor IX infusion between inclusion and the Week 4 visit. It also comprises a 3D mask (to be used before or during infusions) including simulation of the infusions themselves (before infusion) and a relaxing and distracting content (during and after infusions).
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male participant over the age of 6 years, with diagnosed Congenital Hemophilia A or B, whatever the severity is 2. Participant under long-term prophylaxis with intravenous Factor VIII or Factor IX infusions 3. Participant (or the legal guardians if participant age \<18 years) able and willing to give written informed consent and to comply with the requirements of the study protocol 4. Participant affiliated to the national social security or beneficiary to such insurance
Exclusion criteria
1. Participant with known or suspected hypersensitivity to virtual-reality based tools 2. Participant with central venous line for the administration of Factor VIII or Factor IX 3. Participant (and the legal guardians if participant age \<18 years) with history of unreliability or non-cooperation (including for completion of self-reported questionnaires) 4. Participant (and the legal guardians if participant age \<18 years) with insufficient comprehension of French language 5. Participant taking part in another clinical trial 6. Participant deprived of his liberty by judicial or administrative order NB: participants with haemophilia A having participated in the test phase of the study could be included in the clinical study itself after a period of 4 months minimum with no use of the virtual-reality based solution.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Patients' Global Impression of Change (PGIC) Score Greater Than (>) 3 Among Participants and Caregivers | At Week 4 | The PGIC is a 7-point Likert scale, a verbal rating scale that asked the respondent to best describe change in symptoms compared to the beginning of study. Participants/caregivers selected from scale range of 1 (very much worsened) to 7 (very much improved). Higher score indicated improved outcome. |
| Number of Participants With Absolute Adherence to Infusions Measured by 4-Item Morisky Medication Adherence Scale (MMAS-4) Scores | Baseline up to Week 4 | The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence. |
| Number of Participants With Changes in Adherence to Infusions Measured by MMAS-4 by Classes | Baseline up to Week 4 | The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence. |
| Number of Participants Who Scored 4 (High Adherence) Using MMAS-4 Scale at Week 4 | At Week 4 | The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behavior. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence. |
| Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | At Week 4 | Adherence to the VR-based solution was assessed at Week 4 using the MMAS. The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence. |
| Mean Absolute Values of Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before Each Factor VIII or Factor IX Infusion in Participants and Caregivers | At Week 4 | The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10-centimeter (cm) line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety. |
| Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Baseline up to Week 4 | The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety. Participants are categorized based on their A-VAS score values at both Baseline (-5, -3, 0, and 9.1) and Week 4 (-5, -2.3, -1, 0 and 2). The A-VAS score reported within each category represent the mean difference between the score collected after and before infusion (after minus before). A negative value indicates an improvement in anxiety compared to the baseline score, while a positive value indicates a worsening of anxiety compared to the baseline score. |
| Number of Participants With Decrease of 2 Points Out of 10 Points in the A-VAS Scale Before Each Factor VIII or Factor IX Infusion | At Week 4 | The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety. |
| Mean Absolute Values of the Pain Measured by a Pain Visual Analogue Scale (P-VAS) After Each Factor VIII or Factor IX Infusion in Participants | At Week 4 | The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain. |
| Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Baseline up to Week 4 | The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain. Participants are categorized based on P-VAS score values at both Baseline (0, 1.3, 2, 4 and 5) and Week 4 (0, 0.2, 0.4, 5 and 8). A positive value indicates worsening in pain compared to the baseline score. |
| Number of Participants With a Decrease of 2 Points Out of 10 Points in the P-VAS Scale After Each Factor VIII or Factor IX Infusion | Baseline up to Week 4 | The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain. |
| Mean Absolute Values of Anxiety Measured by an A-VAS Scale After Each Factor VIII or Factor IX Infusion in Participants and Caregivers | At Week 4 | The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety. |
| Number of Participants With a Decrease of 2 Points Out of 10 Points in the A-VAS Scale After Each Factor VIII or Factor IX Infusion | Baseline up to Week 4 | The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety and negative value indicated worst health. |
| Absolute Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score | At Week 4 | The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to adult participants to assess the effect of the treatment on the participants' quality of life. Adult participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-3L index score indicated improvement and negative value indicated worst health. |
| Relative Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score | At Week 4 | The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to adult participants to assess the effect of the treatment on the participants' quality of life. Adult participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-3L index score indicated improvement and negative value indicated worst health. Relative variation from baseline at visit (%) = 100 \* Absolute change from baseline at visit (in units) / value at baseline (in units). |
| Absolute Variation of Youth Participants Quality of Life Measured With the European Quality of Life 5 Dimensions For Youth (EQ-5D-Y) Health State Index Score | At Week 4 | The EQ-5D-Y is a standardized instrument for use as a measure of health outcome and was administered to youth participants to assess the effect of the treatment on the participants' quality of life. Youth participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-Y index score indicated improvement and negative value indicated worst health. |
| Relative Variation of Youth Participants Quality of Life Measured With the European Quality of Life 5 Dimensions For Youth (EQ-5D-Y) Health State Index Score | At Week 4 | The EQ-5D-Y is a standardized instrument for use as a measure of health outcome and was administered to youth participants to assess the effect of the treatment on the participants' quality of life. Youth participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-Y index score indicated improvement and negative value indicated worst health. Relative variation from baseline at visit (%) = 100 \* Absolute change from baseline at visit (in units) / value at baseline (in units). |
| Number of Participants and Caregivers With a Decrease of 2 Points in the EQ-5D-3L VAS and EQ-5D-Y Score | At Week 4 | EQ-5D-3L health questionnaire is adult participant and caregivers and EQ-5D-Y is a youth participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =extreme problems) in the relevant health dimension. Higher score indicated a worsening health condition. |
| Absolute Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score | At Week 4 | The STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). Higher scores were positively correlated with higher levels of anxiety. Each type of anxiety has its own scale of 20 different questions and were rated on a 4-point scale (e.g. from 'Almost Never to 'Almost Always'). Low scores indicated a mild form of anxiety, and high scores indicated a severe form of anxiety. STAI score ranged from 20 to 80 where higher scores indicated greater anxiety and negative value indicated worst anxiety. |
| Relative Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score | At Week 4 | The STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). Higher scores were positively correlated with higher levels of anxiety. Each type of anxiety has its own scale of 20 different questions and were rated on a 4-point scale (e.g. from 'Almost Never to 'Almost Always'). Low scores indicated a mild form of anxiety, and high scores indicated a severe form of anxiety. STAI score ranged from 20 to 80 where higher scores indicated greater anxiety and negative value indicated worst anxiety. Relative variation from baseline at visit (%) = 100 \* Absolute change from baseline at visit (in units) / value at baseline (in units). |
| Number of All Participants With Decrease of at Least One Level of State-Trait Anxiety Inventory Severity (STAI-S) | At Week 4 | The STAI-S is a psychological assessment tool used to measure the level of anxiety a person is experiencing at a particular moment in time that assesses both State anxiety (STAI-Y1) and Trait anxiety (STAI-Y2). Each type of anxiety has its own scale of 20 different questions each that are scored on a 4-point scale evaluating how respondents feel right now, at this moment (e.g. from 'Almost Never to 'Almost Always'). Total scores for each (Y1 and Y2) range from 20 to 80, with higher scores correlating with greater anxiety. Severity for each STAI-Y1 and STAI-Y2 is defined by the scores on STAI-S: 20-35 (very low) 36-45 (low) 46-55 (moderate) 56-65 (high) 66-80 (very high). Number of participants with decrease of at least one level of State-Trait Anxiety Inventory- Severity (STAI-S) are reported. |
| Absolute Variation of Participants Depression Measured by Patient Health Questionnaire (Module 9) (PHQ-9) Depression Severity | At Week 4 | The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status. |
| Relative Variation of Participants Depression Measured by Patient Health Questionnaire (Module 9) (PHQ-9) Depression Severity | At Week 4 | The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status. Relative variation from baseline at visit (%) = 100 \* Absolute change from baseline at visit (in units) / value at baseline (in units). |
| Number of Participants With Decrease of at Least One Level of Depression Severity Measured by PHQ-9 Scale | Baseline up to Week 4 | The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants, With Satisfaction, Willingness to Continue the VR-Based Solution Measured by 4-point Likert Scale Score More Than and Equal to (>=3) Among Participants and Caregivers | At Week 4 | A 4-point Likert scale was used to assess the number of participants, caregivers, and investigators with a score of 3 or 4 (satisfied or very satisfied) with the use of the VR- based system. The Likert scale is composed from 1=never satisfied to 4=very satisfied. |
| Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers | At Week 4 | Preference for the VR-based solution in participants and caregivers was assessed using a binary question: Yes (Preference for the VR-based solution) and No (preference for VR-based solution) was assessed. |
| Number of Participants With Related Adverse Events (AEs) and Serious Adverse Events (SAEs) to the Infusions of Factor VIII or Factor IX or VR-Based Solution | From start of study up to Week 4 | An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. AEs related to infusions of Factor VIII or Factor IX or use of VR-based solution was assessed. An SAE is any untoward medical occurrence that at any dose: results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or any other medically important event that, in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. |
| Number of Incidents With the VR-Based Solution | Baseline up to Week 4 | An incident is a minor hardware and/or software event that prevents the correct use of the solution in its context. The incidents were mainly associated with misuse by the user of the solution or with a software and/or hardware failure. |
Countries
France
Participant flow
Recruitment details
Participants took part in the study at the 6 centres in France from 23 June 2023 to 21 February 2024.
Pre-assignment details
A total of 24 male participants with Congenital Haemophilia A or B were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| VR-based Experimental Group: With Autonomy Haemophilia participants with autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions. | 14 |
| VR-based Experimental Group: Without Autonomy Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions. | 10 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient's decision | 1 | 1 |
Baseline characteristics
| Characteristic | VR-based Experimental Group: With Autonomy | VR-based Experimental Group: Without Autonomy | Total |
|---|---|---|---|
| Age, Continuous | 39.3 years STANDARD_DEVIATION 20.6 | 13.9 years STANDARD_DEVIATION 10.6 | 28.7 years STANDARD_DEVIATION 21.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 14 Participants | 10 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 10 |
| other Total, other adverse events | 2 / 14 | 0 / 10 |
| serious Total, serious adverse events | 0 / 14 | 0 / 10 |
Outcome results
Primary
Absolute Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score
The STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). Higher scores were positively correlated with higher levels of anxiety. Each type of anxiety has its own scale of 20 different questions and were rated on a 4-point scale (e.g. from 'Almost Never to 'Almost Always'). Low scores indicated a mild form of anxiety, and high scores indicated a severe form of anxiety. STAI score ranged from 20 to 80 where higher scores indicated greater anxiety and negative value indicated worst anxiety.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Absolute Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score | Absolute variation of the STAI-Y1 | -2.4 Score on a scale | Standard Deviation 7.2 |
| VR-based Experimental Group: With Autonomy | Absolute Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score | Absolute variation of the STAI-Y2 | -2.9 Score on a scale | Standard Deviation 3.1 |
| VR-based Experimental Group: Without Autonomy | Absolute Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score | Absolute variation of the STAI-Y1 | -1.5 Score on a scale | Standard Deviation 3.9 |
| VR-based Experimental Group: Without Autonomy | Absolute Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score | Absolute variation of the STAI-Y2 | -0.5 Score on a scale | Standard Deviation 3 |
Primary
Absolute Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score
The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to adult participants to assess the effect of the treatment on the participants' quality of life. Adult participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-3L index score indicated improvement and negative value indicated worst health.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Absolute Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score | Absolute Variation for adult participants | 0.0 score on a scale | Standard Deviation 0.2 |
| VR-based Experimental Group: With Autonomy | Absolute Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score | Absolute Variation for caregivers | 0.3 score on a scale | Standard Deviation 0.1 |
| VR-based Experimental Group: Without Autonomy | Absolute Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score | Absolute Variation for adult participants | -0.0 score on a scale | Standard Deviation 0.1 |
| VR-based Experimental Group: Without Autonomy | Absolute Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score | Absolute Variation for caregivers | -0.0 score on a scale | Standard Deviation 0.1 |
Primary
Absolute Variation of Participants Depression Measured by Patient Health Questionnaire (Module 9) (PHQ-9) Depression Severity
The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Absolute Variation of Participants Depression Measured by Patient Health Questionnaire (Module 9) (PHQ-9) Depression Severity | -1.3 score on a scale | Standard Deviation 3.2 |
| VR-based Experimental Group: Without Autonomy | Absolute Variation of Participants Depression Measured by Patient Health Questionnaire (Module 9) (PHQ-9) Depression Severity | -1.4 score on a scale | Standard Deviation 4.9 |
Primary
Absolute Variation of Youth Participants Quality of Life Measured With the European Quality of Life 5 Dimensions For Youth (EQ-5D-Y) Health State Index Score
The EQ-5D-Y is a standardized instrument for use as a measure of health outcome and was administered to youth participants to assess the effect of the treatment on the participants' quality of life. Youth participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-Y index score indicated improvement and negative value indicated worst health.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Absolute Variation of Youth Participants Quality of Life Measured With the European Quality of Life 5 Dimensions For Youth (EQ-5D-Y) Health State Index Score | -0.1 score on a scale | Standard Deviation 0.2 |
| VR-based Experimental Group: Without Autonomy | Absolute Variation of Youth Participants Quality of Life Measured With the European Quality of Life 5 Dimensions For Youth (EQ-5D-Y) Health State Index Score | -0.1 score on a scale | Standard Deviation 0.3 |
Primary
Mean Absolute Values of Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before Each Factor VIII or Factor IX Infusion in Participants and Caregivers
The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10-centimeter (cm) line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, number analyzed signifies participants who were evaluable at specified timepoints for the categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Mean Absolute Values of Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before Each Factor VIII or Factor IX Infusion in Participants and Caregivers | A-VAS before infusion For Participants | 0.2 score on a scale | Standard Deviation 0.4 |
| VR-based Experimental Group: With Autonomy | Mean Absolute Values of Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before Each Factor VIII or Factor IX Infusion in Participants and Caregivers | A-VAS before infusion For Caregivers | 1.5 score on a scale | Standard Deviation 2 |
| VR-based Experimental Group: Without Autonomy | Mean Absolute Values of Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before Each Factor VIII or Factor IX Infusion in Participants and Caregivers | A-VAS before infusion For Caregivers | 0.0 score on a scale | Standard Deviation 0 |
Primary
Mean Absolute Values of Anxiety Measured by an A-VAS Scale After Each Factor VIII or Factor IX Infusion in Participants and Caregivers
The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Mean Absolute Values of Anxiety Measured by an A-VAS Scale After Each Factor VIII or Factor IX Infusion in Participants and Caregivers | A-VAS after infusion for caregivers | 0.8 score on a scale | Standard Deviation 2 |
| VR-based Experimental Group: With Autonomy | Mean Absolute Values of Anxiety Measured by an A-VAS Scale After Each Factor VIII or Factor IX Infusion in Participants and Caregivers | A-VAS after infusion for participants | 0.2 score on a scale | Standard Deviation 0.4 |
| VR-based Experimental Group: Without Autonomy | Mean Absolute Values of Anxiety Measured by an A-VAS Scale After Each Factor VIII or Factor IX Infusion in Participants and Caregivers | A-VAS after infusion for caregivers | 0.0 score on a scale | Standard Deviation 0 |
Primary
Mean Absolute Values of the Pain Measured by a Pain Visual Analogue Scale (P-VAS) After Each Factor VIII or Factor IX Infusion in Participants
The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Mean Absolute Values of the Pain Measured by a Pain Visual Analogue Scale (P-VAS) After Each Factor VIII or Factor IX Infusion in Participants | 1.4 score on a scale | Standard Deviation 2.7 |
| VR-based Experimental Group: Without Autonomy | Mean Absolute Values of the Pain Measured by a Pain Visual Analogue Scale (P-VAS) After Each Factor VIII or Factor IX Infusion in Participants | 0.6 score on a scale | Standard Deviation 1.7 |
Primary
Number of All Participants With Decrease of at Least One Level of State-Trait Anxiety Inventory Severity (STAI-S)
The STAI-S is a psychological assessment tool used to measure the level of anxiety a person is experiencing at a particular moment in time that assesses both State anxiety (STAI-Y1) and Trait anxiety (STAI-Y2). Each type of anxiety has its own scale of 20 different questions each that are scored on a 4-point scale evaluating how respondents feel right now, at this moment (e.g. from 'Almost Never to 'Almost Always'). Total scores for each (Y1 and Y2) range from 20 to 80, with higher scores correlating with greater anxiety. Severity for each STAI-Y1 and STAI-Y2 is defined by the scores on STAI-S: 20-35 (very low) 36-45 (low) 46-55 (moderate) 56-65 (high) 66-80 (very high). Number of participants with decrease of at least one level of State-Trait Anxiety Inventory- Severity (STAI-S) are reported.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of All Participants With Decrease of at Least One Level of State-Trait Anxiety Inventory Severity (STAI-S) | Decrease from baseline of at least one level of anxiety state of STAI-Y1 | 3 Participants |
| VR-based Experimental Group: With Autonomy | Number of All Participants With Decrease of at Least One Level of State-Trait Anxiety Inventory Severity (STAI-S) | Decrease from baseline of at least one level of anxiety state of STAI-Y2 | 4 Participants |
| VR-based Experimental Group: Without Autonomy | Number of All Participants With Decrease of at Least One Level of State-Trait Anxiety Inventory Severity (STAI-S) | Decrease from baseline of at least one level of anxiety state of STAI-Y1 | 2 Participants |
| VR-based Experimental Group: Without Autonomy | Number of All Participants With Decrease of at Least One Level of State-Trait Anxiety Inventory Severity (STAI-S) | Decrease from baseline of at least one level of anxiety state of STAI-Y2 | 1 Participants |
Primary
Number of Participants and Caregivers With a Decrease of 2 Points in the EQ-5D-3L VAS and EQ-5D-Y Score
EQ-5D-3L health questionnaire is adult participant and caregivers and EQ-5D-Y is a youth participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =extreme problems) in the relevant health dimension. Higher score indicated a worsening health condition.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants and Caregivers With a Decrease of 2 Points in the EQ-5D-3L VAS and EQ-5D-Y Score | EQ-5D-3L Score for Participants | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants and Caregivers With a Decrease of 2 Points in the EQ-5D-3L VAS and EQ-5D-Y Score | EQ-5D-3L Score for Caregivers | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants and Caregivers With a Decrease of 2 Points in the EQ-5D-3L VAS and EQ-5D-Y Score | EQ-5D-Y Score for Youth Participants | 0 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants and Caregivers With a Decrease of 2 Points in the EQ-5D-3L VAS and EQ-5D-Y Score | EQ-5D-3L Score for Participants | 0 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants and Caregivers With a Decrease of 2 Points in the EQ-5D-3L VAS and EQ-5D-Y Score | EQ-5D-3L Score for Caregivers | 0 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants and Caregivers With a Decrease of 2 Points in the EQ-5D-3L VAS and EQ-5D-Y Score | EQ-5D-Y Score for Youth Participants | 0 Participants |
Primary
Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4
Adherence to the VR-based solution was assessed at Week 4 using the MMAS. The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Participants with Low adherence (0-1) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Participants with Medium adherence (2-3) | 6 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Participants with High adherence (4) | 6 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Caregivers with Low adherence (0-1) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Caregivers with Medium adherence (2-3) | 2 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Caregivers with High adherence (4) | 1 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Caregivers with Medium adherence (2-3) | 0 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Participants with Low adherence (0-1) | 0 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Caregivers with Low adherence (0-1) | 0 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Participants with Medium adherence (2-3) | 5 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Caregivers with High adherence (4) | 5 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants and Caregivers With Adherence to VR-Based Solutions at Week 4 | Participants with High adherence (4) | 4 Participants |
Primary
Number of Participants Who Scored 4 (High Adherence) Using MMAS-4 Scale at Week 4
The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behavior. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants Who Scored 4 (High Adherence) Using MMAS-4 Scale at Week 4 | 7 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants Who Scored 4 (High Adherence) Using MMAS-4 Scale at Week 4 | 6 Participants |
Primary
Number of Participants With Absolute Adherence to Infusions Measured by 4-Item Morisky Medication Adherence Scale (MMAS-4) Scores
The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.
Time frame: Baseline up to Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Adherence to Infusions Measured by 4-Item Morisky Medication Adherence Scale (MMAS-4) Scores | 7 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With Absolute Adherence to Infusions Measured by 4-Item Morisky Medication Adherence Scale (MMAS-4) Scores | 6 Participants |
Primary
Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion
The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain. Participants are categorized based on P-VAS score values at both Baseline (0, 1.3, 2, 4 and 5) and Week 4 (0, 0.2, 0.4, 5 and 8). A positive value indicates worsening in pain compared to the baseline score.
Time frame: Baseline up to Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure were planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy). Here, number analyzed signifies participants who were evaluable at specified timepoints for the categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (0) and Week 4 (0) | 13 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (0) and Week 4 (0.2) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (0) and Week 4 (0.4) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (0) and Week 4 (5) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values Baseline (0) and Week 4 (8) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (1.3) and Week 4 (0) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (1.3) and Week 4 (0.2) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (1.3) and Week 4 (0.4) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (1.3) and Week 4 (5) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (1.3) and Week 4 (8) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (2) and Week 4 (0) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (2) and Week 4 (0.2) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (2) and Week 4 (0.4) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (2) and Week 4 (5) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (2) and Week 4 (8) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (4) and Week 4 (0) | 2 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (4) and Week 4 (0.2) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (4) and Week 4 (0.4) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (4) and Week 4 (5) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (4) and Week 4 (8) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (5) and Week 4 (0) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (5) and Week 4 (0.2) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (5) and Week 4 (0.4) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (5) and Week 4 (5) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Absolute Variation of the Pain Measured by a P-VAS Scale After Each Factor VIII or Factor IX Infusion | Participants with absolute variation of the P-VAS values between Baseline (5) and Week 4 (8) | 0 Participants |
Primary
Number of Participants With a Decrease of 2 Points Out of 10 Points in the A-VAS Scale After Each Factor VIII or Factor IX Infusion
The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety and negative value indicated worst health.
Time frame: Baseline up to Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure was planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants With a Decrease of 2 Points Out of 10 Points in the A-VAS Scale After Each Factor VIII or Factor IX Infusion | 2 Participants |
Primary
Number of Participants With a Decrease of 2 Points Out of 10 Points in the P-VAS Scale After Each Factor VIII or Factor IX Infusion
The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain.
Time frame: Baseline up to Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure was planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants With a Decrease of 2 Points Out of 10 Points in the P-VAS Scale After Each Factor VIII or Factor IX Infusion | 4 Participants |
Primary
Number of Participants With a Patients' Global Impression of Change (PGIC) Score Greater Than (>) 3 Among Participants and Caregivers
The PGIC is a 7-point Likert scale, a verbal rating scale that asked the respondent to best describe change in symptoms compared to the beginning of study. Participants/caregivers selected from scale range of 1 (very much worsened) to 7 (very much improved). Higher score indicated improved outcome.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants With a Patients' Global Impression of Change (PGIC) Score Greater Than (>) 3 Among Participants and Caregivers | PGIC: Patients (Score >3) | 7 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With a Patients' Global Impression of Change (PGIC) Score Greater Than (>) 3 Among Participants and Caregivers | PGIC: Caregivers (Score >3) | 2 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With a Patients' Global Impression of Change (PGIC) Score Greater Than (>) 3 Among Participants and Caregivers | PGIC: Patients (Score >3) | 4 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With a Patients' Global Impression of Change (PGIC) Score Greater Than (>) 3 Among Participants and Caregivers | PGIC: Caregivers (Score >3) | 2 Participants |
Primary
Number of Participants With Changes in Adherence to Infusions Measured by MMAS-4 by Classes
The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.
Time frame: Baseline up to Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants With Changes in Adherence to Infusions Measured by MMAS-4 by Classes | Participants with changes in Low adherence (0-1) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Changes in Adherence to Infusions Measured by MMAS-4 by Classes | Participants with changes in Medium adherence (2-3) | 6 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Changes in Adherence to Infusions Measured by MMAS-4 by Classes | Participants with changes in High adherence (4) | 7 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With Changes in Adherence to Infusions Measured by MMAS-4 by Classes | Participants with changes in Low adherence (0-1) | 0 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With Changes in Adherence to Infusions Measured by MMAS-4 by Classes | Participants with changes in Medium adherence (2-3) | 3 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With Changes in Adherence to Infusions Measured by MMAS-4 by Classes | Participants with changes in High adherence (4) | 6 Participants |
Primary
Number of Participants With Decrease of 2 Points Out of 10 Points in the A-VAS Scale Before Each Factor VIII or Factor IX Infusion
The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure was planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants With Decrease of 2 Points Out of 10 Points in the A-VAS Scale Before Each Factor VIII or Factor IX Infusion | 5 Participants |
Primary
Number of Participants With Decrease of at Least One Level of Depression Severity Measured by PHQ-9 Scale
The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status.
Time frame: Baseline up to Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants With Decrease of at Least One Level of Depression Severity Measured by PHQ-9 Scale | 2 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With Decrease of at Least One Level of Depression Severity Measured by PHQ-9 Scale | 3 Participants |
Primary
Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion
The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety. Participants are categorized based on their A-VAS score values at both Baseline (-5, -3, 0, and 9.1) and Week 4 (-5, -2.3, -1, 0 and 2). The A-VAS score reported within each category represent the mean difference between the score collected after and before infusion (after minus before). A negative value indicates an improvement in anxiety compared to the baseline score, while a positive value indicates a worsening of anxiety compared to the baseline score.
Time frame: Baseline up to Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure were planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy). Here, number analyzed signifies participants who were evaluable at specified timepoints for the categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (-5) and Week 4 (-5) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (-5) and Week 4 (-2.3) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (-5) and Week 4 (-1) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (-5) and Week 4 (0) | 2 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (-5) and Week 4 (2) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (-3) and Week 4 (-5) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (-3) and Week 4 (-2.3) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (-3) and Week 4 (-1) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (-3) and Week 4 (0) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (-3) and Week 4 (2) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (0) and Week 4 (-5) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (0) and Week 4 (-2.3) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (0) and Week 4 (-1) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (0) and Week 4 (0) | 14 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (0) and Week 4 (2) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (9.1) and Week 4 (-5) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (9.1) and Week 4 (-2.3) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (9.1) and Week 4 (-1) | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (9.1) and Week 4 (0) | 1 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Relative Variation in Anxiety Measured by an Anxiety Visual Analogue Scale (A-VAS) Before and After Each Factor VIII or Factor IX Infusion | Participants with variation of the anxiety VAS values between Baseline (9.1) and Week 4 (2) | 0 Participants |
Primary
Relative Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score
The STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). Higher scores were positively correlated with higher levels of anxiety. Each type of anxiety has its own scale of 20 different questions and were rated on a 4-point scale (e.g. from 'Almost Never to 'Almost Always'). Low scores indicated a mild form of anxiety, and high scores indicated a severe form of anxiety. STAI score ranged from 20 to 80 where higher scores indicated greater anxiety and negative value indicated worst anxiety. Relative variation from baseline at visit (%) = 100 \* Absolute change from baseline at visit (in units) / value at baseline (in units).
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Relative Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score | Relative variation of the STAI-Y1 | -6.6 percentage | Standard Deviation 21 |
| VR-based Experimental Group: With Autonomy | Relative Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score | Relative variation of the STAI-Y2 | -8.1 percentage | Standard Deviation 8.1 |
| VR-based Experimental Group: Without Autonomy | Relative Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score | Relative variation of the STAI-Y1 | -3.7 percentage | Standard Deviation 12.7 |
| VR-based Experimental Group: Without Autonomy | Relative Variation of All Participants Anxiety Measured by State-Trait Anxiety Inventory (STAI-Y) Score | Relative variation of the STAI-Y2 | -1.5 percentage | Standard Deviation 10.2 |
Primary
Relative Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score
The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to adult participants to assess the effect of the treatment on the participants' quality of life. Adult participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-3L index score indicated improvement and negative value indicated worst health. Relative variation from baseline at visit (%) = 100 \* Absolute change from baseline at visit (in units) / value at baseline (in units).
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Relative Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score | Relative Variation for adult participants | 7.1 percentage | Standard Deviation 32.7 |
| VR-based Experimental Group: With Autonomy | Relative Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score | Relative Variation for caregivers | 61.0 percentage | Standard Deviation 34.8 |
| VR-based Experimental Group: Without Autonomy | Relative Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score | Relative Variation for adult participants | -5.1 percentage | Standard Deviation 7.2 |
| VR-based Experimental Group: Without Autonomy | Relative Variation of Caregivers and Adult Participants Quality of Life Measured With the European Quality of Life 5 Dimensions 3-Levels (EQ-5D-3L) Health State Index Score | Relative Variation for caregivers | -2.0 percentage | Standard Deviation 11.8 |
Primary
Relative Variation of Participants Depression Measured by Patient Health Questionnaire (Module 9) (PHQ-9) Depression Severity
The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status. Relative variation from baseline at visit (%) = 100 \* Absolute change from baseline at visit (in units) / value at baseline (in units).
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Relative Variation of Participants Depression Measured by Patient Health Questionnaire (Module 9) (PHQ-9) Depression Severity | -13.7 percentage | Standard Deviation 28.2 |
| VR-based Experimental Group: Without Autonomy | Relative Variation of Participants Depression Measured by Patient Health Questionnaire (Module 9) (PHQ-9) Depression Severity | 51.9 percentage | Standard Deviation 161.2 |
Primary
Relative Variation of Youth Participants Quality of Life Measured With the European Quality of Life 5 Dimensions For Youth (EQ-5D-Y) Health State Index Score
The EQ-5D-Y is a standardized instrument for use as a measure of health outcome and was administered to youth participants to assess the effect of the treatment on the participants' quality of life. Youth participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-Y index score indicated improvement and negative value indicated worst health. Relative variation from baseline at visit (%) = 100 \* Absolute change from baseline at visit (in units) / value at baseline (in units).
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Relative Variation of Youth Participants Quality of Life Measured With the European Quality of Life 5 Dimensions For Youth (EQ-5D-Y) Health State Index Score | -21.2 percentage | Standard Deviation 35.3 |
| VR-based Experimental Group: Without Autonomy | Relative Variation of Youth Participants Quality of Life Measured With the European Quality of Life 5 Dimensions For Youth (EQ-5D-Y) Health State Index Score | -12.8 percentage | Standard Deviation 32.8 |
Secondary
Number of Incidents With the VR-Based Solution
An incident is a minor hardware and/or software event that prevents the correct use of the solution in its context. The incidents were mainly associated with misuse by the user of the solution or with a software and/or hardware failure.
Time frame: Baseline up to Week 4
Population: The IS included all eligible participants with or without assessment at the end of the Week 4 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Incidents With the VR-Based Solution | 3 number of incidents |
| VR-based Experimental Group: Without Autonomy | Number of Incidents With the VR-Based Solution | 1 number of incidents |
Secondary
Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers
Preference for the VR-based solution in participants and caregivers was assessed using a binary question: Yes (Preference for the VR-based solution) and No (preference for VR-based solution) was assessed.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers | Preference for the VR-based solution - Participants | Yes | 5 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers | Preference for the VR-based solution - Participants | No | 8 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers | Preference for the VR-based solution - Caregivers | Yes | 2 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers | Preference for the VR-based solution - Caregivers | No | 1 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers | Preference for the VR-based solution - Caregivers | No | 1 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers | Preference for the VR-based solution - Participants | Yes | 7 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers | Preference for the VR-based solution - Caregivers | Yes | 4 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With Preference and No-preference for the VR-Based Solution Using a Binary Question Among Participants and Caregivers | Preference for the VR-based solution - Participants | No | 2 Participants |
Secondary
Number of Participants With Related Adverse Events (AEs) and Serious Adverse Events (SAEs) to the Infusions of Factor VIII or Factor IX or VR-Based Solution
An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. AEs related to infusions of Factor VIII or Factor IX or use of VR-based solution was assessed. An SAE is any untoward medical occurrence that at any dose: results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or any other medically important event that, in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
Time frame: From start of study up to Week 4
Population: The IS included all eligible participants with or without assessment at the end of the Week 4 visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants With Related Adverse Events (AEs) and Serious Adverse Events (SAEs) to the Infusions of Factor VIII or Factor IX or VR-Based Solution | Participants with related AEs | 0 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants With Related Adverse Events (AEs) and Serious Adverse Events (SAEs) to the Infusions of Factor VIII or Factor IX or VR-Based Solution | Participants with SAEs | 0 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With Related Adverse Events (AEs) and Serious Adverse Events (SAEs) to the Infusions of Factor VIII or Factor IX or VR-Based Solution | Participants with related AEs | 0 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants With Related Adverse Events (AEs) and Serious Adverse Events (SAEs) to the Infusions of Factor VIII or Factor IX or VR-Based Solution | Participants with SAEs | 0 Participants |
Secondary
Number of Participants, With Satisfaction, Willingness to Continue the VR-Based Solution Measured by 4-point Likert Scale Score More Than and Equal to (>=3) Among Participants and Caregivers
A 4-point Likert scale was used to assess the number of participants, caregivers, and investigators with a score of 3 or 4 (satisfied or very satisfied) with the use of the VR- based system. The Likert scale is composed from 1=never satisfied to 4=very satisfied.
Time frame: At Week 4
Population: The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VR-based Experimental Group: With Autonomy | Number of Participants, With Satisfaction, Willingness to Continue the VR-Based Solution Measured by 4-point Likert Scale Score More Than and Equal to (>=3) Among Participants and Caregivers | Satisfaction: Participants (Score >=3) | 10 Participants |
| VR-based Experimental Group: With Autonomy | Number of Participants, With Satisfaction, Willingness to Continue the VR-Based Solution Measured by 4-point Likert Scale Score More Than and Equal to (>=3) Among Participants and Caregivers | Satisfaction: Caregivers (Score >=3) | 2 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants, With Satisfaction, Willingness to Continue the VR-Based Solution Measured by 4-point Likert Scale Score More Than and Equal to (>=3) Among Participants and Caregivers | Satisfaction: Participants (Score >=3) | 9 Participants |
| VR-based Experimental Group: Without Autonomy | Number of Participants, With Satisfaction, Willingness to Continue the VR-Based Solution Measured by 4-point Likert Scale Score More Than and Equal to (>=3) Among Participants and Caregivers | Satisfaction: Caregivers (Score >=3) | 4 Participants |