Aging Well
Conditions
Keywords
Aging well, virtual reality, activity, learning
Brief summary
The purpose of this clinical trial is to learn more about the potential for using virtual reality in older adults living in residences for elderly to maintain health (physical activity, cognitive activity, social behaviors). The main questions it aims to answer are: * To what extent can virtual reality be a tool to support health in older adults? * What are the support needs of older adults in learning to use this immersive technology? Participants are invited to complete 5 weekly training sessions on the use of a virtual reality headset. At the beginning and end of each session, participants will complete a questionnaire on their perception of their experience. During the sessions, the participants are asked to test games that mobilize the upper limbs. Two learning modalities are set up in two separate groups. These modalities aim to test two different support formulas in order to compare the support needs of the elderly in the use and integration of virtual reality to support the activities and health of this population.
Interventions
OTHERIndividual assistance Virtual reality training sessions
5 virtual reality training sessions where feedback will be provided to each individual by the research team
OTHERCollective assistance Virtual reality training sessions
4 virtual reality training sessions where feedback will be provided to the whole group by the research team and 1 session where feedback will be individual. No participant was ever assigned to this intervention.
Sponsors
Natural Sciences and Engineering Research Council, Canada
SEC Fonds Immobilier Groupe Maurice
TOPMED
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
2 groups with different learning modalities (individual feedback compared to collective feedback)
Eligibility
Sex/Gender
ALL
Age
64 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Independent person living in the sponsor's retirement home
Exclusion criteria
* Having a pacemaker * Being at risk for epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Learning of Virtual Reality Tasks | During each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29) | Total score on 43 different tasks using a 5 point scale for each task(impossible(0), completion with external help(1), delay before individual completion and multiple repetitions(2), individual completion with less than 2 repetitions(3), individual completion without repetition(4) scored from 0 to 4 respectively). Scores for each session are averaged (Total score range from 0 to 4). Interpretations should be taken with caution(see Analysis population description). |
| Ease | Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29) | Measurement of the perception of ease using a one item 5 point scale (higher score means higher ease during the session).Total score range from 1 to 5. |
| Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5 | Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29) | measurement of the perception of sense of control using a one item 1-5 point scale (higher score means higher sense of control during the session).Total score range from 1 to 5. |
| Satisfaction With Supervision | Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29) | measurement of the perception of satisfaction using a one item 5 point scale (higher score means higher satisfaction during the session). Total score range from 1 to 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress Level at the Start of the Session | Immediately before each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29) | Measurement of the participants' stress level using a 1-item scale from 1 to 5 (lower score means higher stress), total scale range is 1 to 5 |
| Desire to Play Virtual Reality Games | Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29) | number of participants mentionning the desire to play virtual reality games |
Countries
Canada
Participant flow
Recruitment details
No participant was ever assigned to the collective assistance group.
Pre-assignment details
The collective assistance group was abandonned because tests revealed issues with ability of participants to help each other during VR sessions.
Participants by arm
| Arm | Count |
|---|---|
| Individual Assistance 5 sessions with individual assistance
The Virtual Reality (VR) activity will take the form of five (5) training sessions.
* Session 1: Basics of VR.
* Session 2: 1-multiplayer game mode.
* Session 3: Playing with a library. Browsing a library
* Session 4: 2-individual game mode.
* Session 5: Game practice.
For each session, in small groups of 3 people, it will be proposed to test games requiring only movements of the upper limbs of low to moderate intensity. Sitting will be mandatory for the tests in order to avoid falls.
Individual assistance Virtual reality training sessions: 5 virtual reality training sessions where feedback will be provided to each individual by the research team | 34 |
| Collective Assistance The collective assistance group was abandonned because tests revealed issues with ability of participants to help each other during VR sessions. No participants were ever assigned to this group. | 0 |
| Total | 34 |
Baseline characteristics
| Characteristic | Individual Assistance | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 34 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 34 Participants | 34 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Region of Enrollment Canada | 34 participants | 34 participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 0 |
| other Total, other adverse events | 0 / 34 | 0 / 0 |
| serious Total, serious adverse events | 0 / 34 | 0 / 0 |
Outcome results
Primary
Ease
Measurement of the perception of ease using a one item 5 point scale (higher score means higher ease during the session).Total score range from 1 to 5.
Time frame: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Population: Number of participants analyzed for each session varies based on the number of participants present that day. Since group session were scheduled, absent participants couldn't complete the session later.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Assistance | Ease | Session 1(day 1) | 4.06 units on a scale | Standard Deviation 1.01 |
| Individual Assistance | Ease | Session 2(day 8) | 3.53 units on a scale | Standard Deviation 1.16 |
| Individual Assistance | Ease | Session 3(day 15) | 4.11 units on a scale | Standard Deviation 1.03 |
| Individual Assistance | Ease | Session 4(day 22) | 3.58 units on a scale | Standard Deviation 1.18 |
| Individual Assistance | Ease | Session 5(day 29) | 4.00 units on a scale | Standard Deviation 1.19 |
Primary
Learning of Virtual Reality Tasks
Total score on 43 different tasks using a 5 point scale for each task(impossible(0), completion with external help(1), delay before individual completion and multiple repetitions(2), individual completion with less than 2 repetitions(3), individual completion without repetition(4) scored from 0 to 4 respectively). Scores for each session are averaged (Total score range from 0 to 4). Interpretations should be taken with caution(see Analysis population description).
Time frame: During each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Population: The evaluators were also tasked to provide assistance to the participants, if needed, during sessions. However, the amount of assistance needed by the participants was much higher than anticipated and hindered data collection. Each task and each participant were missing data. Some participants were missing data for up to 80% of all tasks for a session. As an example, for a particular task, only 7 participants provided data in session 1, whereas in session 3, 26 participants provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Assistance | Learning of Virtual Reality Tasks | Session 1 | 2.13 score on a scale | Standard Deviation 0.1 |
| Individual Assistance | Learning of Virtual Reality Tasks | Session 2 | 2.17 score on a scale | Standard Deviation 0.08 |
| Individual Assistance | Learning of Virtual Reality Tasks | Session 3 | 2.22 score on a scale | Standard Deviation 0.1 |
| Individual Assistance | Learning of Virtual Reality Tasks | Session 4 | 2.22 score on a scale | Standard Deviation 0.15 |
| Individual Assistance | Learning of Virtual Reality Tasks | Session 5 | 2.28 score on a scale | Standard Deviation 0.1 |
Primary
Satisfaction With Supervision
measurement of the perception of satisfaction using a one item 5 point scale (higher score means higher satisfaction during the session). Total score range from 1 to 5.
Time frame: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Population: Number of participants analyzed for each session varies based on the number of participants present that day. Since group session were scheduled, absent participants couldn't complete the session later.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Assistance | Satisfaction With Supervision | Session 1(day 1) | 4.76 score on a scale | Standard Deviation 0.61 |
| Individual Assistance | Satisfaction With Supervision | Session 2(day 8) | 4.41 score on a scale | Standard Deviation 0.95 |
| Individual Assistance | Satisfaction With Supervision | Session 3(day 15) | 4.68 score on a scale | Standard Deviation 0.26 |
| Individual Assistance | Satisfaction With Supervision | Session 4(day 22) | 4.35 score on a scale | Standard Deviation 0.95 |
| Individual Assistance | Satisfaction With Supervision | Session 5(day 29) | 4.93 score on a scale | Standard Deviation 0.37 |
Primary
Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5
measurement of the perception of sense of control using a one item 1-5 point scale (higher score means higher sense of control during the session).Total score range from 1 to 5.
Time frame: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Population: Number of participants analyzed for each session varies based on the number of participants present that day. Since group session were scheduled, absent participants couldn't complete the session later.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Assistance | Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5 | Session 1(day 1) | 3.85 units on a scale | Standard Deviation 0.82 |
| Individual Assistance | Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5 | Session 2(day 8) | 3.53 units on a scale | Standard Deviation 0.92 |
| Individual Assistance | Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5 | Session 3(day 15) | 3.57 units on a scale | Standard Deviation 0.96 |
| Individual Assistance | Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5 | Session 4(day 22) | 3.19 units on a scale | Standard Deviation 1.14 |
| Individual Assistance | Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5 | Session 5(day 29) | 3.79 units on a scale | Standard Deviation 1.07 |
Secondary
Desire to Play Virtual Reality Games
number of participants mentionning the desire to play virtual reality games
Time frame: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Population: The collective assistance group was abandonned because tests revealed issues with ability of participants to help each other during VR sessions. No participants were ever assigned to this group.~Number of participants analyzed for each session varies based on the number of participants present that day. Since group session were scheduled, absent participants couldn't complete the session later.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individual Assistance | Desire to Play Virtual Reality Games | Session 1(Day 1) | 4 Participants |
| Individual Assistance | Desire to Play Virtual Reality Games | Session 2(Day 8) | 3 Participants |
| Individual Assistance | Desire to Play Virtual Reality Games | Session 3(Day 15) | 2 Participants |
| Individual Assistance | Desire to Play Virtual Reality Games | Session 4(Day 22) | 4 Participants |
| Individual Assistance | Desire to Play Virtual Reality Games | Session 5(Day 29) | 9 Participants |
Secondary
Stress Level at the Start of the Session
Measurement of the participants' stress level using a 1-item scale from 1 to 5 (lower score means higher stress), total scale range is 1 to 5
Time frame: Immediately before each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Population: Number of participants analyzed for each session varies based on the number of participants present that day. Since group session were scheduled, absent participants couldn't complete the session later.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Assistance | Stress Level at the Start of the Session | Session 1(day 1) | 4.38 score on a scale | Standard Deviation 0.85 |
| Individual Assistance | Stress Level at the Start of the Session | Session 2(day 8) | 4.78 score on a scale | Standard Deviation 0.55 |
| Individual Assistance | Stress Level at the Start of the Session | Session 3(day 15) | 4.89 score on a scale | Standard Deviation 0.42 |
| Individual Assistance | Stress Level at the Start of the Session | Session 4(day 22) | 4.77 score on a scale | Standard Deviation 0.5 |
| Individual Assistance | Stress Level at the Start of the Session | Session 5(day 29) | 4.76 score on a scale | Standard Deviation 0.44 |