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Dementia PreventionNCT05383118

e-Learning About Cognitive Impairment and Dementia Prevention

A study testing Education Intervention in people with Dementia Prevention, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this proposal, the investigators plan to study the effectiveness of our web-based intervention on dementia prevention knowledge, intentions, and behaviour change. Participants will be randomized to one of two groups - intervention and control. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia Prevention
What is being tested?
Education Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
536 participants
Where
1 siteCanada
Study dates
27 Mar 2023to 3 Aug 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 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • No prior diagnosis of dementia
  • Live in Canada
  • 16 years of age and over
  • Good command of the English language
  • Access to email and internet
  • Comfortable using email and internet, and
  • Ability to grant online informed consent

Who cannot join

  • Prior diagnosis of dementia
  • Lives outside of Canada
  • Not 16 years of age or over
  • Does not speak English,
  • Does not have access to email or internet
  • Is not comfortable using email of internet
  • Does not grant informed consent

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McMaster University

    Hamilton, Ontario, L8S 4L8

Other trials in Canada

About this study

Official title: Dementia Prevention Internet-Based Intervention: Randomized Controlled Trial and Knowledge Translation

In this proposal, the investigators plan to study the effectiveness of our web-based intervention on dementia prevention knowledge, intentions, and behaviour change. Participants will be randomized to one of two groups - intervention and control. Participants randomized to the intervention group will receive the dementia prevention e-learning. Participants in the control group will be assigned an alternate-topic e-learning lesson. All participants will be given access to all e-learning at the conclusion of the study.

The purpose of this phase is to explore if and how our dementia prevention e-learning influences participants' knowledge, intentions and health behaviours related to dementia risk.

Read the detailed description

Background:

With our aging population, the prevalence of dementia is increasing dramatically. Developing a better understanding of how dementia can be prevented and sharing information about how Canadians can reduce their risk of developing dementia or delay its onset is critical to keeping Canadians healthy and improving quality of life. Web-based interventions in dementia have been shown to be effective for a range of outcomes, but very few have been widely implemented or rigorously studied; additionally, national, and provincial guidelines have all highlighted the importance of online resources to improve dementia prevention education. This has been further brought into focus by the coronavirus pandemic. While there have been studies of web-based health information on intentions and behaviour change, the vast majority of those studies have looked at text-based health information, rather than internet-based interventions that have incorporated best practices in instructional design for e-learning. This project will help to address this gap in the literature, as improved instructional design should have an impact on knowledge gain, which the investigators hypothesize may increase intentions and behaviour change.

The investigators developed a high-quality, award-winning web- and email-based dementia prevention education platform for care partners, which includes asynchronous, multimedia e-learning lessons and email-based 'micro-learning' content to reinforce the learning.

Objective:

In this proposal, the investigators plan to study the effectiveness of our web-based intervention on dementia prevention knowledge, intentions, and behaviour change.

Methods:

Design, Setting, and Participants:

This study is a sequential explanatory mixed methods design randomized controlled trial. Following eligibility screening, informed consent, and baseline socio-demographic measures, participants will be randomized either to the intervention group or the control group. Those adults (age ≥ 16) who have no prior diagnosis of dementia, have internet and email access, and are fluent in English will be eligible to participate. Participants will be randomized and directed to their assigned learning path after submitting online informed consent and baseline measures using the Division of e-Learning Innovation's research platform. Participants will be randomized using a block randomization. To the best of our ability, efforts will be made to blind participants to their allocation group and study hypotheses.

Intervention:

Participants randomized to the intervention group will receive the dementia prevention e-learning. Participants in the control group will be assigned an alternate-topic e-learning lesson. All participants will be given access to all e-learning at the conclusion of the study.

Outcomes:

The purpose of this phase is to explore if and how our dementia prevention e-learning influences participants' knowledge, intentions and health behaviours related to dementia risk.

The specific aims are:

  1. To evaluate whether exposure to the e-learning intervention changes knowledge of dementia risk factors, intention to engage in risk reduction activities, and health behaviours related to dementia prevention.
  2. To explore qualitative aspects such as participants' engagement and satisfaction with the intervention, as well as barriers and facilitators to use, through surveys and synchronous online focus groups.

Implications and Relevance:

The results of this study will contribute to the planning of a larger randomized controlled trial (RCT) in the future; as well as the evaluation of innovative, cost-effective, and efficient dementia prevention resources that can complement traditional approaches. The intervention could be easily scaled and spread to complement other dementia education methods.

Being tested
Education Intervention, Education Control
Keywords
Web-based intervention, Knowledge Translation, Clinical Trial, Education and Training, Alzheimer disease, Caregiver, Dementia, Internet
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education InterventionBehavioural

    Participants in the intervention group will be provided e-learning about dementia prevention and promoting brain health, consisting of following components:

    1. One multimedia e-learning lesson on promoting brain health and preventing dementia;
    2. A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson.
    3. Curated resources related to dementia risk factors
  • Education ControlBehavioural

    Participants in the control group will be provided e-learning about mild cognitive impairment, consisting of following components:

    1. One multimedia e-learning lesson on mild cognitive impairment;
    2. A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson.
    3. Curated resources related to mild cognitive impairment
Study groups in NCT05383118
Study groupRoleWhat they receive
Education InterventionExperimentalParticipants in the intervention group will be provided e-learning about dementia prevention and promoting brain health, consisting of following components: 1. One multimedia e-learning lesson on promoting brain health and preventing dementia; 2. A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson. 3. Curated resources related to dementia risk factors
Receives: Behavioral: Education Intervention
Education ControlActive comparatorParticipants in the control group will be provided e-learning about mild cognitive impairment, consisting of following components: 1. One multimedia e-learning lesson on mild cognitive impairment; 2. A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson. 3. Curated resources related to mild cognitive impairment
Receives: Behavioral: Education Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knowledge change (custom 15-item knowledge questionnaire related to key dementia prevention modifiable risk factors

    A custom 15-item knowledge questionnaire (multiple true-false response) to measure change related to key dementia prevention modifiable risk factors. Items are pulled from other validated surveys (i.e., Dementia Knowledge Assessment Scale) and key dementia prevention modifiable risk factors.

    Measured: 0 weeks, 4 weeks, 12 weeks

Secondary outcomes (2)
  1. Intentions change (custom 10-item intentions questionnaire related to key dementia prevention modifiable risk factors)

    Intentions related to dementia prevention.

    A custom 10-item intentions questionnaire (7 point Likert scale) to measure intentions to change related to key dementia prevention modifiable risk factors. Items were created based on key modifiable risk factors related to dementia as identified by the 2020 Lancet Commission Report.

    Measured: 0 weeks, 4 weeks, 12 weeks

  2. Behaviour change

    Behaviour change related to dementia prevention.

    A custom 42-item health behaviours questionnaire (Likert response options) to measure health behaviours related to key dementia prevention modifiable risk factors. Items are pulled from other validated surveys (Health and Behaviour Survey, Godin Leisure Time Exercise Questionnaire, World Health Organization for smoking status, etc.) and key dementia prevention modifiable risk factors.

    Measured: 0 weeks, 4 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start27 Mar 2023
  3. Primary completion3 Aug 2023
  4. Study completion3 Aug 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
536 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05383118
Sponsor's protocol ID
Levinson_ISFR
Status last verified
Aug 2023
First submitted
5 May 2022
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Levinson AJ, Ayers S, Clark S, Woodburn R, Dobbins M, Duarte D, Grad R, Kates N, Marr S, Oliver D, Papaioannou A, Saperson K, Siu H, Strudwick G, Sztramko R, Neil-Sztramko S. Internet-Based Dementia Prevention Intervention (DementiaRisk): Protocol for a Randomized Controlled Trial and Knowledge Translation. JMIR Res Protoc. 2025 Jan 27;14:e64718. doi: 10.2196/64718.

    PubMed 39869903

Questions about this trial

What is this clinical trial studying?

A study testing Education Intervention in people with Dementia Prevention, run by McMaster University 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 7 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: finished, as of the sponsor's last update on 21 Aug 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Knowledge change (custom 15-item knowledge questionnaire related to key dementia prevention modifiable risk factors (time frame: 0 weeks, 4 weeks, 12 weeks). 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 NCT05383118, which also lists 1 linked publication.

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 21 Aug 2023.

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