search
Back to results

e-Learning About Cognitive Impairment and Dementia Prevention

Primary Purpose

Dementia Prevention

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Education Intervention
Education Control
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia Prevention focused on measuring Web-based intervention, Knowledge Translation, Clinical Trial, Education and Training, Alzheimer disease, Caregiver, Dementia, Internet

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
  • Ability to grant online informed consent, and
  • Complete online baseline assessments.

Exclusion Criteria:

  • 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
  • Does not complete baseline assessments.

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Education Intervention

Education Control

Arm Description

Participants in the intervention group will be provided e-learning about dementia prevention and promoting brain health, consisting of following components: One multimedia e-learning lesson on promoting brain health and preventing dementia; A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson. Curated resources related to dementia risk factors

Participants in the control group will be provided e-learning about mild cognitive impairment, consisting of following components: One multimedia e-learning lesson on mild cognitive impairment; A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson. Curated resources related to mild cognitive impairment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 5, 2022
Last Updated
August 17, 2023
Sponsor
McMaster University
Collaborators
Public Health Agency of Canada (PHAC)
search

1. Study Identification

Unique Protocol Identification Number
NCT05383118
Brief Title
e-Learning About Cognitive Impairment and Dementia Prevention
Official Title
Dementia Prevention Internet-Based Intervention: Randomized Controlled Trial and Knowledge Translation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
August 3, 2023 (Actual)
Study Completion Date
August 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Public Health Agency of Canada (PHAC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Prevention
Keywords
Web-based intervention, Knowledge Translation, Clinical Trial, Education and Training, Alzheimer disease, Caregiver, Dementia, Internet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Efforts will be made to blind participants to their allocation group (intervention or control). To do this, we will ensure that promotional advertisements do not contain logos or direct website links. The informed consent form will not contain the exact outcome measures or the title of the intervention. To the best of our abilities, allocation concealment will be aided by referring to the intervention as 'e-learning about cognitive impairment and dementia prevention', without biasing participants to study hypotheses or study design.
Allocation
Randomized
Enrollment
536 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education Intervention
Arm Type
Experimental
Arm Description
Participants in the intervention group will be provided e-learning about dementia prevention and promoting brain health, consisting of following components: One multimedia e-learning lesson on promoting brain health and preventing dementia; A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson. Curated resources related to dementia risk factors
Arm Title
Education Control
Arm Type
Active Comparator
Arm Description
Participants in the control group will be provided e-learning about mild cognitive impairment, consisting of following components: One multimedia e-learning lesson on mild cognitive impairment; A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson. Curated resources related to mild cognitive impairment
Intervention Type
Behavioral
Intervention Name(s)
Education Intervention
Intervention Description
Participants in the intervention group will be provided e-learning about dementia prevention and promoting brain health, consisting of following components: One multimedia e-learning lesson on promoting brain health and preventing dementia; A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson. Curated resources related to dementia risk factors
Intervention Type
Behavioral
Intervention Name(s)
Education Control
Intervention Description
Participants in the control group will be provided e-learning about mild cognitive impairment, consisting of following components: One multimedia e-learning lesson on mild cognitive impairment; A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson. Curated resources related to mild cognitive impairment
Primary Outcome Measure Information:
Title
Knowledge change (custom 15-item knowledge questionnaire related to key dementia prevention modifiable risk factors
Description
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.
Time Frame
0 weeks, 4 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Intentions change (custom 10-item intentions questionnaire related to key dementia prevention modifiable risk factors)
Description
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.
Time Frame
0 weeks, 4 weeks, 12 weeks
Title
Behaviour change
Description
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.
Time Frame
0 weeks, 4 weeks, 12 weeks
Other Pre-specified Outcome Measures:
Title
Intervention adherence (time spent)
Description
Lesson completion data, email open rates, and resource downloads will be collected and saved to quantify the time(s) spent on intervention activities.
Time Frame
4 weeks
Title
Participant satisfaction
Description
A custom satisfaction questionnaire data adapted from the Information Assessment Method For All (IAM4all) will be collected and saved to assess satisfaction with the intervention.
Time Frame
4 weeks
Title
Participant satisfaction
Description
A custom implementation oral interview questionnaire adapted from The Consolidated Framework for Implementation Research (CFIR) will be collected and saved to assess implementation of the intervention.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

e-Learning About Cognitive Impairment and Dementia Prevention

We'll reach out to this number within 24 hrs