Vision and Hearing LossSENSE-BHProNCT07856888
SENSE-Brain Health Pro for Older Adults With Sensory Loss
A study testing Brain Health Pro in people with Vision and Hearing Loss and Vision Impairment, run by Université de Montréal at 1 site in Canada.
Trial summary
The goal of this study is to learn about the outcomes, usability, and accessibility of the online Brain Health Pro program for older adults with hearing difficulties, vision difficulties, or both. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Vision and Hearing Loss, Vision Impairment, Hearing Impairment
- What is being tested?
- Brain Health Pro
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2026to 15 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 55 years of age or older.
- Reside in Canada.
- Self-report vision difficulties, hearing difficulties, or both (dual sensory difficulties), as determined using the study's sensory screening questionnaire adapted from the Canadian Longitudinal Study on Aging (CLSA) and the COMPASS-ND clinical assessment battery.
- Have no self-reported diagnosis of dementia or Alzheimer's disease. Individuals with self-reported mild cognitive impairment (MCI) will be eligible.
- Be willing to complete the study's self-reported cognitive screening questionnaire, including questions regarding previous cognitive diagnosis, subjective cognitive decline, and family history of dementia.
- Have access to a computer, tablet, or smartphone with internet access and be willing to participate in the web-based BHPro program using accessibility features and/or assistive technologies, as needed.
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- Be able to communicate in English or French using their preferred accessible communication format.
- Be able and willing to provide informed consent.
- Be willing to participate in the six-month BHPro intervention and complete the scheduled study assessments.
- Have a primary care provider (e.g., family physician or nurse practitioner) or another healthcare professional involved in their care and agree that clinically significant incidental findings, if any, may be communicated to that provider.
Who cannot join
- Self-reported diagnosis of dementia or Alzheimer's disease.
- Inability, in the opinion of the investigator, to provide informed consent or to participate safely and meaningfully in study procedures.
- Insufficient proficiency in English or French to complete the BHPro program and study questionnaires, even with available accessibility supports.
- Vision and/or hearing difficulties that would preclude participation in the online BHPro program or completion of study assessments, even with usual corrective aids, assistive technologies, accessibility features, or support from the study team.
- Lack of access to an internet-enabled device and internet connection sufficient to participate in the online BHPro program and complete study procedures.
- Inability or unwillingness to receive study communications by email, telephone, videoconference, or another mutually acceptable remote communication format.
- Participation in another intervention study that, in the opinion of the investigator, would interfere with participation in BHPro or interpretation of study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
School of Optometry
Montreal, Quebec, H3T 1P1
Elena Guseva, PhD, +1514 343 7962, elena.guseva@umontreal.ca
Walter Wittich, PhD FAAO CLVT, +1514 343 7962, walter.wittich@umontreal.ca
About this study
Official title: SENSE-Brain Health Pro: Evaluation of a Digital Intervention Targeting Modifiable Dementia Risk Factors in Older Adults With Sensory Loss
The goal of this study is to learn about the outcomes, usability, and accessibility of the online Brain Health Pro program for older adults with hearing difficulties, vision difficulties, or both. Brain Health Pro (BHPro) provides information and practical suggestions about ways people may support their brain health and lower their risk of dementia.
The main questions this study aims to answer are:
Read more
Does participants' knowledge about dementia and its risk factors change after using Brain Health Pro? How usable and accessible is Brain Health Pro for people with hearing or vision difficulties? What factors help or make it more difficult for participants to use and complete the program?
About 300 adults aged 55 years and older with hearing difficulties, vision difficulties, or both will take part in the study. Participants will:
Use the online Brain Health Pro program for six months. Complete online questionnaires before starting the program and again at 3 and 6 months.
Share their experiences using the program, including any difficulties related to hearing, vision, or using the online program.
Researchers will also look at whether participants make changes in health behaviours that may support brain health and whether they feel more confident about making these changes.
Read the detailed description
SENSE-Brain Health Pro (SENSE-BHPro) is a prospective, multi-site study using a one-group pretest-post-test design with an embedded mixed-methods process evaluation. The study evaluates the accessibility, acceptability, usability, and outcomes associated with participation in the web-based Brain Health Pro (BHPro) program among older adults with self-reported hearing and/or vision difficulties.
Hearing and vision difficulties are common in older adulthood and are associated with increased risk of cognitive decline and dementia. Digital dementia prevention programs have the potential to reach large numbers of older adults; however, sensory difficulties may create barriers to accessing and engaging with digitally delivered interventions. The original BHPro program was not specifically implemented in a population selected for hearing and/or vision difficulties, and its accessibility and usability in this population have not been systematically evaluated. SENSE-BHPro addresses this gap by examining both intervention outcomes and the accessibility and implementation of BHPro for older adults with sensory difficulties.
Approximately 300 community-dwelling adults aged 55 years and older with self-reported hearing difficulties, vision difficulties, or combined hearing and vision difficulties will be recruited across Canada. Participants will have no self-reported diagnosis of dementia. Individuals who are cognitively unimpaired, report subjective cognitive concerns, or have mild cognitive impairment may participate if they otherwise meet the study eligibility criteria.
Participants will complete the BHPro program, a web-based multidomain psychoeducational dementia risk-reduction program. BHPro provides individualized feedback on potentially modifiable dementia risk factors and evidence-based educational content addressing lifestyle, vascular, psychosocial, and cognitive health domains. Participants receive a personalized risk profile, practical recommendations, and structured guidance intended to support goal setting and self-management. The core intervention is delivered progressively through structured online modules over six months.
Assessments will occur at screening, baseline, Month 3, and Month 6. The primary outcome is change in knowledge about Alzheimer's disease from baseline to Month 6, assessed using the Alzheimer's Disease Knowledge Scale (ADKS). Secondary and exploratory evaluations include self-efficacy, uptake of risk-reducing behaviours, psychological well-being, lifestyle factors, usability, acceptability, accessibility, and engagement with the intervention.
Accessibility is a central component of the study. Participants will receive information and guidance regarding accessibility features available within BHPro and on their own devices, such as captions, text magnification, contrast settings, and audio adjustments, as appropriate. Use of accessibility features and assistive technologies will be documented to better understand how participants with different sensory profiles engage with the digital intervention.
Outcomes and implementation experiences will also be examined across three sensory subgroups: participants with hearing difficulties, vision difficulties, and combined hearing and vision difficulties. The study will also examine individual characteristics that may influence engagement and outcomes, including sensory profile and severity, demographic characteristics, cognitive status, and the perceived functional effects of sensory difficulties.
An embedded process evaluation will examine recruitment pathways, participant engagement, adherence patterns, accessibility needs, barriers and facilitators to participation, and implementation considerations relevant to integrating BHPro within primary care and community-based settings serving older adults with hearing and/or vision difficulties. Findings are intended to inform future adaptations and implementation of accessible digital dementia risk-reduction programs.
- Being tested
- Brain Health Pro
- Keywords
- Dementia Risk Reduction, Brain Health, Sensory Loss, Dual Sensory Loss, Digital Health, Dementia Literacy, Health Education, Accessibility, Brain Health PRO, SENSE-BHPro
- Medical subject headings
- Deaf-Blind Disorders, Vision Disorders, Hearing Loss, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Health ProBehavioural
Brain Health Pro (BHPro) is a web-based educational program designed to support dementia risk reduction. Participants receive personalized information about potentially modifiable dementia risk factors and evidence-based recommendations related to lifestyle, vascular, psychosocial, and cognitive health. The program supports goal setting and behaviour change through structured online modules delivered progressively over six months.
| Study group | Role | What they receive |
|---|---|---|
| Brain Health Pro | Experimental | Participants will use the Brain Health Pro (BHPro) web-based program for six months. BHPro provides personalized information and recommendations about potentially modifiable dementia risk factors and supports participants in making health and lifestyle changes that may promote brain health. Receives: Behavioral: Brain Health Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge About Alzheimer's Disease Assessed Using the Alzheimer's Disease Knowledge Scale (ADKS)
Knowledge about Alzheimer's disease will be assessed using the Alzheimer's Disease Knowledge Scale (ADKS). The ADKS is a 30-item questionnaire with true/false response options that assesses knowledge about Alzheimer's disease across several domains. Each correct response receives one point, producing a total score ranging from 0 to 30. Higher scores indicate greater knowledge about Alzheimer's disease. Change in ADKS total score from baseline to Month 6 will be evaluated.
Measured: Baseline to 6 months
Secondary outcomes (3)
Change in Self-Efficacy Assessed Using the General Self-Efficacy Scale (GSE)
Self-efficacy will be assessed using the General Self-Efficacy Scale (GSE), a 10-item questionnaire measuring perceived ability to cope with difficult situations and achieve goals. Each item is rated on a 4-point scale. Item scores are summed to produce a total score ranging from 10 to 40, with higher scores indicating greater perceived self-efficacy. Change in GSE total score from baseline to Month 3 and Month 6 will be evaluated.
Measured: Baseline to Month 3 and Month 6
Usability of Brain Health Pro Assessed Using the Adapted System Usability Scale (SUS)
Usability will be assessed using the System Usability Scale (SUS), adapted for SENSE-Brain Health Pro. The adapted questionnaire includes items assessing frequency of website use and perceived usability, including ease of use, navigation, complexity, consistency, confidence, need for technical assistance, and ease of learning. Usability items are rated on a 5-point scale from strongly disagree to strongly agree. Additional study-specific items assess accessibility and are reported separately as an accessibility outcome.
Measured: 3 months and 6 months
Acceptability of Brain Health Pro Assessed Using the Adapted Technology Acceptance Model (TAM) Questionnaire
Acceptability will be assessed using a 29-item Technology Acceptance Model (TAM) Questionnaire adapted for SENSE-Brain Health Pro. The questionnaire includes 26 structured items assessing perceived usefulness, communication, everyday benefits, website experience, and accessibility experience. Structured items are rated on a 7-point scale from strongly disagree to strongly agree. Three open-ended questions assess helpful accessibility features, suggested accessibility improvements, and barriers experienced while using Brain Health Pro.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision and Hearing LossStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the Brain Health Pro intervention. Outcomes will be assessed within participants over time using a one-group pretest-post-test design.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Walter Wittich, PhD FAAO CLVT, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856888
- Sponsor's protocol ID
- 2026-8428
- Acronym
- SENSE-BHPro
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant privacy and confidentiality considerations and because data sharing with external researchers is not included in the current study protocol and consent process.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENSE-Brain Health Pro: Evaluation of a Digital Intervention Targeting Modifiable Dementia Risk Factors in Older Adults With Sensory Loss
- ClinicalTrials.gov ID
- NCT07856888
- Acronym / sponsor ID
- SENSE-BHPro / 2026-8428
- Keywords
- Dementia Risk Reduction, Brain Health, Sensory Loss, Dual Sensory Loss, Digital Health, Dementia Literacy, Health Education, Accessibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 5 Oct 2026 (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.
The goal of this study is to learn about the outcomes, usability, and accessibility of the online Brain Health Pro program for older adults with hearing difficulties, vision difficulties, or both. Brain Health Pro (BHPro) provides information and practical suggestions about ways people may support their brain health and lower their risk of dementia.
The main questions this study aims to answer are:
Does participants' knowledge about dementia and its risk factors change after using Brain Health Pro? How usable and accessible is Brain Health Pro for people with hearing or vision difficulties? What factors help or make it more difficult for participants to use and complete the program?
About 300 adults aged 55 years and older with hearing difficulties, vision difficulties, or both will take part in the study. Participants will:
Use the online Brain Health Pro program for six months. Complete online questionnaires before starting the program and again at 3 and 6 months.
Share their experiences using the program, including any difficulties related to hearing, vision, or using the online program.
Researchers will also look at whether participants make changes in health behaviours that may support brain health and whether they feel more confident about making these changes.
Detailed description
SENSE-Brain Health Pro (SENSE-BHPro) is a prospective, multi-site study using a one-group pretest-post-test design with an embedded mixed-methods process evaluation. The study evaluates the accessibility, acceptability, usability, and outcomes associated with participation in the web-based Brain Health Pro (BHPro) program among older adults with self-reported hearing and/or vision difficulties.
Hearing and vision difficulties are common in older adulthood and are associated with increased risk of cognitive decline and dementia. Digital dementia prevention programs have the potential to reach large numbers of older adults; however, sensory difficulties may create barriers to accessing and engaging with digitally delivered interventions. The original BHPro program was not specifically implemented in a population selected for hearing and/or vision difficulties, and its accessibility and usability in this population have not been systematically evaluated. SENSE-BHPro addresses this gap by examining both intervention outcomes and the accessibility and implementation of BHPro for older adults with sensory difficulties.
Approximately 300 community-dwelling adults aged 55 years and older with self-reported hearing difficulties, vision difficulties, or combined hearing and vision difficulties will be recruited across Canada. Participants will have no self-reported diagnosis of dementia. Individuals who are cognitively unimpaired, report subjective cognitive concerns, or have mild cognitive impairment may participate if they otherwise meet the study eligibility criteria.
Participants will complete the BHPro program, a web-based multidomain psychoeducational dementia risk-reduction program. BHPro provides individualized feedback on potentially modifiable dementia risk factors and evidence-based educational content addressing lifestyle, vascular, psychosocial, and cognitive health domains. Participants receive a personalized risk profile, practical recommendations, and structured guidance intended to support goal setting and self-management. The core intervention is delivered progressively through structured online modules over six months.
Assessments will occur at screening, baseline, Month 3, and Month 6. The primary outcome is change in knowledge about Alzheimer's disease from baseline to Month 6, assessed using the Alzheimer's Disease Knowledge Scale (ADKS). Secondary and exploratory evaluations include self-efficacy, uptake of risk-reducing behaviours, psychological well-being, lifestyle factors, usability, acceptability, accessibility, and engagement with the intervention.
Accessibility is a central component of the study. Participants will receive information and guidance regarding accessibility features available within BHPro and on their own devices, such as captions, text magnification, contrast settings, and audio adjustments, as appropriate. Use of accessibility features and assistive technologies will be documented to better understand how participants with different sensory profiles engage with the digital intervention.
Outcomes and implementation experiences will also be examined across three sensory subgroups: participants with hearing difficulties, vision difficulties, and combined hearing and vision difficulties. The study will also examine individual characteristics that may influence engagement and outcomes, including sensory profile and severity, demographic characteristics, cognitive status, and the perceived functional effects of sensory difficulties.
An embedded process evaluation will examine recruitment pathways, participant engagement, adherence patterns, accessibility needs, barriers and facilitators to participation, and implementation considerations relevant to integrating BHPro within primary care and community-based settings serving older adults with hearing and/or vision difficulties. Findings are intended to inform future adaptations and implementation of accessible digital dementia risk-reduction programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the Brain Health Pro intervention. Outcomes will be assessed within participants over time using a one-group pretest-post-test design.
| Arm | Type | Receives |
|---|---|---|
| Brain Health Pro | Experimental | Behavioral: Brain Health ProParticipants will use the Brain Health Pro (BHPro) web-based program for six months. BHPro provides personalized information and recommendations about potentially modifiable dementia risk factors and supports participants in making health and lifestyle changes that may promote brain health. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be 55 years of age or older.
- Reside in Canada.
- Self-report vision difficulties, hearing difficulties, or both (dual sensory difficulties), as determined using the study's sensory screening questionnaire adapted from the Canadian Longitudinal Study on Aging (CLSA) and the COMPASS-ND clinical assessment battery.
- Have no self-reported diagnosis of dementia or Alzheimer's disease. Individuals with self-reported mild cognitive impairment (MCI) will be eligible.
- Be willing to complete the study's self-reported cognitive screening questionnaire, including questions regarding previous cognitive diagnosis, subjective cognitive decline, and family history of dementia.
Key exclusion criteria (7 listed)
- Self-reported diagnosis of dementia or Alzheimer's disease.
- Inability, in the opinion of the investigator, to provide informed consent or to participate safely and meaningfully in study procedures.
- Insufficient proficiency in English or French to complete the BHPro program and study questionnaires, even with available accessibility supports.
- Vision and/or hearing difficulties that would preclude participation in the online BHPro program or completion of study assessments, even with usual corrective aids, assistive technologies, accessibility features, or support from the study team.
- Lack of access to an internet-enabled device and internet connection sufficient to participate in the online BHPro program and complete study procedures.
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 |
|---|---|---|
| Brain Health ProBrain Health Pro (BHPro) is a web-based educational program designed to support dementia risk reduction. Participants receive personalized information about potentially modifiable dementia risk factors and evidence-based recommendations related to lifestyle, vascular, psychosocial, and cognitive health. The program supports goal setting and behaviour change through structured online modules delivered progressively over six months. | Behavioural | Brain Health Pro |
Primary outcome
Change in Knowledge About Alzheimer's Disease Assessed Using the Alzheimer's Disease Knowledge Scale (ADKS)
Time frame: Baseline to 6 months
Knowledge about Alzheimer's disease will be assessed using the Alzheimer's Disease Knowledge Scale (ADKS). The ADKS is a 30-item questionnaire with true/false response options that assesses knowledge about Alzheimer's disease across several domains. Each correct response receives one point, producing a total score ranging from 0 to 30. Higher scores indicate greater knowledge about Alzheimer's disease. Change in ADKS total score from baseline to Month 6 will be evaluated.
3 secondary outcomes
Change in Self-Efficacy Assessed Using the General Self-Efficacy Scale (GSE)
Time frame: Baseline to Month 3 and Month 6
Usability of Brain Health Pro Assessed Using the Adapted System Usability Scale (SUS)
Time frame: 3 months and 6 months
Acceptability of Brain Health Pro Assessed Using the Adapted Technology Acceptance Model (TAM) Questionnaire
Time frame: 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant privacy and confidentiality considerations and because data sharing with external researchers is not included in the current study protocol and consent process.
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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.
Walter Wittich, PhD FAAO CLVT principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Health Pro in people with Vision and Hearing Loss and Vision Impairment, run by Université de Montréal at 1 site 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 10 inclusion and 7 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Guseva, PhD (514 343 7962, elena.guseva@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knowledge About Alzheimer's Disease Assessed Using the Alzheimer's Disease Knowledge Scale (ADKS) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.