Age-related Macular DegenerationWOTBNCT04276610
Words on the Brain: Can Reading Rehabilitation for Age-Related Vision Impairment Improve Cognitive Functioning?
A study testing Low Vision Reading Rehabilitation in people with Age-related Macular Degeneration and Dementia, run by Université de Montréal at 2 sites in Canada.
Trial summary
Age-related vision impairment and dementia both become more prevalent with increasing age. Research into the mechanisms of these conditions has proposed that some of their causes (e.g., macular degeneration/glaucoma and Alzheimer's disease) could be symptoms of an underlying common cause, or may be equally linked to a… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration, Dementia, Low Vision
- What is being tested?
- Low Vision Reading Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesCanada
- Study dates
- 16 May 2017to 28 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Able to communicate in either English or French
- Impairment of central vision, affecting acuity due to any diagnosis
- Visual acuity in the better eye with best standard correction of 20/60 or less
- Potential benefit from magnification or other reading rehabilitation interventions, as determined by rehabilitation professional.
- Client dossier with one of the partnering rehabilitation agencies.
Who cannot join
- Complete blindness
- Inability to communicate verbally
- Inability to independently give informed written consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institut Nazareth et Louis-Braille du CISSS de la Montérégie-Centre
Longueuil, Quebec, J4K 5G4
Centre de réadaptation Lethbridge-Layton-Mackay du CIUSSS du Centre-Ouest-de-l'Île-de-Montréal
Montreal, Quebec, H4B 1R3
About this study
Age-related vision impairment and dementia both become more prevalent with increasing age. Research into the mechanisms of these conditions has proposed that some of their causes (e.g., macular degeneration/glaucoma and Alzheimer's disease) could be symptoms of an underlying common cause, or may be equally linked to a multifactorial context in frailty and aging. Research into sensory-cognitive aging has provided preliminary data that sensory decline may be linked to the progression of dementia through the concept of sensory deprivation. Preliminary data in hearing loss rehabilitation support the idea that improved hearing may have a beneficial effect on cognitive functioning; however, there are to date no data available to examine whether low vision rehabilitation, specifically for reading, could have an equally protective or beneficial effect on cognitive health. The present proposal aims to fill this gap.
Read the detailed description
The research questions are the following:
- Does low vision rehabilitation reduce reading effort?
- If so, does reduced reading effort increase reading activity,
- If so, does increased reading activity improve cognitive (memory) functioning?
The objectives are to:
- Evaluate cognitive functioning and memory before, and 6 and 12 months after low vision reading rehabilitation using magnification in patients with age-related macular degeneration or glaucoma, compared to age-matched visually impaired controls who undergo rehabilitation that is NOT related to reading (e.g., mobility)
- Correlate participant characteristics with all cognitive outcome variables in order to identify potential mediators, moderators or confounders
Hypotheses:
- Measures of reading (subjective and objective effort) will be statistically significantly reduced after participants have received strategies and tools to facilitate reading.
- Measures of reading behaviour will be negatively correlated with measures of reading effort (e.g., participants who report less effort will read more, more frequently and for longer)
- Individuals that demonstrate reduced reading effort/improved reading behaviour will demonstrate improved scores on cognitive tests after 6 months of having received rehabilitation strategies and tools, compared to those whose reading effort remains high or whose reading behaviour remains unchanged. These beneficial effects will be maintained after 12 months.
Methodology
Study Design: The study utilizes a quasi-experimental approach (nonrandomized, pre-post intervention study), an approach frequently used during the evaluation of health interventions. Specifically, a 2x3 design (2 groups x 3 time points) will allow for the examination of whether cognitive performance will change before and after 6 and 12 months of a low vision reading intervention, when comparing low vision patients to age-matched controls. Participants will also be audio-recorded throughout several of the tasks to not only ensure the highest level of precision when inputting and analyzing data, but will also help reduce the overall testing time.
- Conditions
- Age-related Macular Degeneration, Dementia, Low Vision, Low Vision Aids, Hearing Loss, Reading Problem
- Being tested
- Low Vision Reading Rehabilitation
- Medical subject headings
- Macular Degeneration, Dementia, Vision, Low, Hearing Loss, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Vision Reading RehabilitationBehavioural
Also called Use of magnification devices
Following Time 1, participants will receive the full complement of vision rehabilitation services available and deemed suitable by their clinical staff and rehabilitation professionals of either rehabilitation centre, according to the provision of assistive devices and services regulated by the Quebec Health Insurance (RAMQ). These services are include but are not limited to: a full optometric exam to determine functional vision, including refraction and the prescription of appropriate near and distance glasses and optical devices, an assessment by a low vision therapist and/or occupational therapist, the loan provision of hand-held optical magnification devices, electronic non-optical magnification devices (e.g., portable or table-top closed-circuit televisions), or computer software for screen content magnification (e.g., ZoomText), with appropriate training and follow-up sessions in the home, if required.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Participants | No intervention | Older adults (65+) without impairments in vision or hearing. This groups will simply be followed for the study period (1 year), measured at 6 months intervals, to provide control comparison data for all outcome measures |
| Low Vision Participants | Experimental | Older adults (65+) with impairments in vision but without hearing impairment. This groups will receive regular standard of low vision rehabilitation care and will be followed for the study period (1 year), measured at 6 months intervals. Receives: Behavioral: Low Vision Reading Rehabilitation |
| Dual Sensory Impairment Participants | Experimental | Older adults (65+) with impairments in both vision hearing hearing. This groups will receive regular standard of low vision rehabilitation care and will be followed for the study period (1 year), measured at 6 months intervals. Receives: Behavioral: Low Vision Reading Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rey Auditory Verbal Learning Test (RAVLT)
Participants are verbally presented with a list of 15 words that they are asked to repeat and memorize, then recall immediately, and again recall them 15 minutes later. The score is the number of items recalled from 0 to 15, with higher scores indicating better recall.
Measured: 15 minutes
Letter Number Sequencing task
Participants are asked to speak out loud the first 13 letters of the alphabet and alternate them with consecutive numbers (e.g., 1 - A - 2 - B 3 -C ...). The score is the number of correct alternations between numbers and letter, from 0 to 26, with higher scores indicating better performance.
Measured: 2 minutes
Montreal Cognitive Assessment - full or blind version
Participants are asked to complete the visual and auditory items of this cognitive screening measure. The Blind versions (no visual items is utilized for persons whose vision is too impaired to see the pictograms). The score is the total number of items completed correctly, ranging from 0 to 30 for the full version, and 0 to 22 for the Blind version, with higher scores indicating better outcomes
Measured: 4 minutes
1-n-back task
Participants are asked to verbally repeat a string of numbers presented orally, while naming the previous item to the one just presented. The score is the total number of correct recalls, ranging from 0 to 25, with higher scores indicating better performance.
Measured: 3 minutes
Secondary outcomes (4)
Minnesota Reading Test (MNRead)
Participants are asked to read individual sentences on an eye chart. The log score indicates reading acuity ranging from -0.1 to 1.0 with higher numbers indicating poorer acuity.
Measured: 2 minutes
Depression, Anxiety and Stress Scale
A 21-item questionnaire that measures the self-reported perception of depression, anxiety and stress on its three sub-scales, respectively. Scores for each item are from 0 to 3. Higher scores indicate higher levels of perceived depression, anxiety and stress, ranging each from 0 to 21 for each sub-scale.
Measured: 5 minutes
Canadian Digit Triplet Test
A test measuring speech-in-noise perception. Participants are presented with three spoken digits through a head-set, and are asked to then enter them on a keyboard. Correct repetition will increase background noise, while incorrect answers will decrease background noise. The outcome measure is the estimated threshold for the signal-to-noise ratio where a participant can still comprehend the spoken digits. More negative score ratios indicate more tolerance to noise, therefore indicating better performance
Measured: 4 minutes
Magnetic Resonance Imaging (MRI) - for subset of participants
Cortical invasive scan to measure structure and volume of brain regions involved in reading and sensory processing. Participants will placed in a Magnetic Resonance Imaging scanner in order to obtain structural measurement of their cortical architecture. Participants are asked to remain still a possible during these scans; however, they are not required to be otherwise engaged in any activity or decision-making. Higher volume measures indicate that more cortical volume is allocated to specific brain regions. This does not necessarily imply a functional judgment on its capacity, but is an anatomical measure only.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start16 May 2017
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Why it stopped: COVID-19 has delayed the study recruitment beyond the available funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Walter Wittich, Université de Montréal
- Investigators
- Walter Wittich, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276610
- Sponsor's protocol ID
- CRIR-1284-1217
- Acronym
- WOTB
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2020
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wittich W, Pichora-Fuller MK, Johnson A, Joubert S, Kehayia E, Bachir V, Aubin G, Jaiswal A, Phillips N. Effect of Reading Rehabilitation for Age-Related Macular Degeneration on Cognitive Functioning: Protocol for a Nonrandomized Pre-Post Intervention Study. JMIR Res Protoc. 2021 Mar 11;10(3):e19931. doi: 10.2196/19931.
PubMed 33704074Aubin G, Phillips N, Jaiswal A, Johnson AP, Joubert S, Bachir V, Kehayia E, Wittich W. Visual and cognitive functioning among older adults with low vision before vision rehabilitation: A pilot study. Front Psychol. 2023 Mar 22;14:1058951. doi: 10.3389/fpsyg.2023.1058951. eCollection 2023.
PubMed 37034930
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Words on the Brain: Can Reading Rehabilitation for Age-Related Vision Impairment Improve Cognitive Functioning?
- ClinicalTrials.gov ID
- NCT04276610
- Acronym / sponsor ID
- WOTB / CRIR-1284-1217
- Conditions
- Age-related Macular Degeneration, Dementia, Low Vision, Low Vision Aids, Hearing Loss, Reading Problem
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 has delayed the study recruitment beyond the available funding
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Canadian Institutes of Health Research (CIHR)
- Study start
- 16 May 2017 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Age-related vision impairment and dementia both become more prevalent with increasing age. Research into the mechanisms of these conditions has proposed that some of their causes (e.g., macular degeneration/glaucoma and Alzheimer's disease) could be symptoms of an underlying common cause, or may be equally linked to a multifactorial context in frailty and aging. Research into sensory-cognitive aging has provided preliminary data that sensory decline may be linked to the progression of dementia through the concept of sensory deprivation. Preliminary data in hearing loss rehabilitation support the idea that improved hearing may have a beneficial effect on cognitive functioning; however, there are to date no data available to examine whether low vision rehabilitation, specifically for reading, could have an equally protective or beneficial effect on cognitive health. The present proposal aims to fill this gap.
Detailed description
The research questions are the following:
- Does low vision rehabilitation reduce reading effort?
- If so, does reduced reading effort increase reading activity,
- If so, does increased reading activity improve cognitive (memory) functioning?
The objectives are to:
- Evaluate cognitive functioning and memory before, and 6 and 12 months after low vision reading rehabilitation using magnification in patients with age-related macular degeneration or glaucoma, compared to age-matched visually impaired controls who undergo rehabilitation that is NOT related to reading (e.g., mobility)
- Correlate participant characteristics with all cognitive outcome variables in order to identify potential mediators, moderators or confounders
Hypotheses:
- Measures of reading (subjective and objective effort) will be statistically significantly reduced after participants have received strategies and tools to facilitate reading.
- Measures of reading behaviour will be negatively correlated with measures of reading effort (e.g., participants who report less effort will read more, more frequently and for longer)
- Individuals that demonstrate reduced reading effort/improved reading behaviour will demonstrate improved scores on cognitive tests after 6 months of having received rehabilitation strategies and tools, compared to those whose reading effort remains high or whose reading behaviour remains unchanged. These beneficial effects will be maintained after 12 months.
Methodology
Study Design: The study utilizes a quasi-experimental approach (nonrandomized, pre-post intervention study), an approach frequently used during the evaluation of health interventions. Specifically, a 2x3 design (2 groups x 3 time points) will allow for the examination of whether cognitive performance will change before and after 6 and 12 months of a low vision reading intervention, when comparing low vision patients to age-matched controls. Participants will also be audio-recorded throughout several of the tasks to not only ensure the highest level of precision when inputting and analyzing data, but will also help reduce the overall testing time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Participants | No intervention | –Older adults (65+) without impairments in vision or hearing. This groups will simply be followed for the study period (1 year), measured at 6 months intervals, to provide control comparison data for all outcome measures |
| Low Vision Participants | Experimental | Behavioral: Low Vision Reading RehabilitationOlder adults (65+) with impairments in vision but without hearing impairment. This groups will receive regular standard of low vision rehabilitation care and will be followed for the study period (1 year), measured at 6 months intervals. |
| Dual Sensory Impairment Participants | Experimental | Behavioral: Low Vision Reading RehabilitationOlder adults (65+) with impairments in both vision hearing hearing. This groups will receive regular standard of low vision rehabilitation care and will be followed for the study period (1 year), measured at 6 months intervals. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Able to communicate in either English or French
- Impairment of central vision, affecting acuity due to any diagnosis
- Visual acuity in the better eye with best standard correction of 20/60 or less
- Potential benefit from magnification or other reading rehabilitation interventions, as determined by rehabilitation professional.
- Client dossier with one of the partnering rehabilitation agencies.
Key exclusion criteria (3 listed)
- Complete blindness
- Inability to communicate verbally
- Inability to independently give informed written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Vision Reading RehabilitationAlso: Use of magnification devicesFollowing Time 1, participants will receive the full complement of vision rehabilitation services available and deemed suitable by their clinical staff and rehabilitation professionals of either rehabilitation centre, according to the provision of assistive devices and services regulated by the Quebec Health Insurance (RAMQ). These services are include but are not limited to: a full optometric exam to determine functional vision, including refraction and the prescription of appropriate near and distance glasses and optical devices, an assessment by a low vision therapist and/or occupational therapist, the loan provision of hand-held optical magnification devices, electronic non-optical magnification devices (e.g., portable or table-top closed-circuit televisions), or computer software for screen content magnification (e.g., ZoomText), with appropriate training and follow-up sessions in the home, if required. | Behavioural | Dual Sensory Impairment Participants, Low Vision Participants |
Primary outcome
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: 15 minutes
Participants are verbally presented with a list of 15 words that they are asked to repeat and memorize, then recall immediately, and again recall them 15 minutes later. The score is the number of items recalled from 0 to 15, with higher scores indicating better recall.
Letter Number Sequencing task
Time frame: 2 minutes
Participants are asked to speak out loud the first 13 letters of the alphabet and alternate them with consecutive numbers (e.g., 1 - A - 2 - B 3 -C ...). The score is the number of correct alternations between numbers and letter, from 0 to 26, with higher scores indicating better performance.
Montreal Cognitive Assessment - full or blind version
Time frame: 4 minutes
Participants are asked to complete the visual and auditory items of this cognitive screening measure. The Blind versions (no visual items is utilized for persons whose vision is too impaired to see the pictograms). The score is the total number of items completed correctly, ranging from 0 to 30 for the full version, and 0 to 22 for the Blind version, with higher scores indicating better outcomes
1-n-back task
Time frame: 3 minutes
Participants are asked to verbally repeat a string of numbers presented orally, while naming the previous item to the one just presented. The score is the total number of correct recalls, ranging from 0 to 25, with higher scores indicating better performance.
4 secondary outcomes
Minnesota Reading Test (MNRead)
Time frame: 2 minutes
Depression, Anxiety and Stress Scale
Time frame: 5 minutes
Canadian Digit Triplet Test
Time frame: 4 minutes
Magnetic Resonance Imaging (MRI) - for subset of participants
Time frame: 45 minutes
Results and safety
The study was stopped early (reason given: COVID-19 has delayed the study recruitment beyond the available funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 33704074Wittich W, Pichora-Fuller MK, Johnson A, Joubert S, Kehayia E, Bachir V, Aubin G, Jaiswal A, Phillips N. Effect of Reading Rehabilitation for Age-Related Macular Degeneration on Cognitive Functioning: Protocol for a Nonrandomized Pre-Post Intervention Study. JMIR Res Protoc. 2021 Mar 11;10(3):e19931. doi: 10.2196/19931.
- Results publication: PubMed 37034930Aubin G, Phillips N, Jaiswal A, Johnson AP, Joubert S, Bachir V, Kehayia E, Wittich W. Visual and cognitive functioning among older adults with low vision before vision rehabilitation: A pilot study. Front Psychol. 2023 Mar 22;14:1058951. doi: 10.3389/fpsyg.2023.1058951. eCollection 2023.
- Open-access link for protocol publicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Wittich, PhD principal investigator
Université de Montréal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Vision Reading Rehabilitation in people with Age-related Macular Degeneration and Dementia, run by Université de Montréal at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 has delayed the study recruitment beyond the available funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rey Auditory Verbal Learning Test (RAVLT) (time frame: 15 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04276610, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.