Clinical trial NCT05383118: e-Learning About Cognitive Impairment and Dementia Prevention
Official title: Dementia Prevention Internet-Based Intervention: Randomized Controlled Trial and Knowledge Translation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Prevention
Keywords: Web-based intervention
Knowledge Translation
Clinical Trial
Education and Training
Alzheimer disease
Caregiver
Dementia
Internet
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2022-05-19
Enrollment: 536
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: Knowledge change (custom 15-item knowledge questionnaire related to key dementia prevention modifiable risk factors
timeFrame: 0 weeks, 4 weeks, 12 weeks
Secondary outcomes:
measure: Intentions change (custom 10-item intentions questionnaire related to key dementia prevention modifiable risk factors)
timeFrame: 0 weeks, 4 weeks, 12 weeks
measure: Behaviour change
timeFrame: 0 weeks, 4 weeks, 12 weeks
Other outcomes:
measure: Intervention adherence (time spent)
timeFrame: 4 weeks
measure: Participant satisfaction
timeFrame: 4 weeks
measure: Participant satisfaction
timeFrame: 4 weeks
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: