Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05383118
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2022-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
e-Learning About Cognitive Impairment and Dementia Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "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."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 536}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intervention adherence (time spent)', 'timeFrame': '4 weeks', 'description': 'Lesson completion data, email open rates, and resource downloads will be collected and saved to quantify the time(s) spent on intervention activities.'}, {'measure': 'Participant satisfaction', 'timeFrame': '4 weeks', '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.'}, {'measure': 'Participant satisfaction', 'timeFrame': '4 weeks', '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.'}], 'primaryOutcomes': [{'measure': 'Knowledge change (custom 15-item knowledge questionnaire related to key dementia prevention modifiable risk factors', 'timeFrame': '0 weeks, 4 weeks, 12 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Intentions change (custom 10-item intentions questionnaire related to key dementia prevention modifiable risk factors)', 'timeFrame': '0 weeks, 4 weeks, 12 weeks', 'description': 'Intentions related to dementia prevention.\n\nA 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.'}, {'measure': 'Behaviour change', 'timeFrame': '0 weeks, 4 weeks, 12 weeks', 'description': 'Behaviour change related to dementia prevention.\n\nA 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Web-based intervention', 'Knowledge Translation', 'Clinical Trial', 'Education and Training', 'Alzheimer disease', 'Caregiver', 'Dementia', 'Internet'], 'conditions': ['Dementia Prevention']}, 'referencesModule': {'references': [{'pmid': '39869903', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.", 'detailedDescription': "Background:\n\nWith 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.\n\nThe 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.\n\nObjective:\n\nIn this proposal, the investigators plan to study the effectiveness of our web-based intervention on dementia prevention knowledge, intentions, and behaviour change.\n\nMethods:\n\nDesign, Setting, and Participants:\n\nThis 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.\n\nIntervention:\n\nParticipants 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.\n\nOutcomes:\n\nThe 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.\n\nThe specific aims are:\n\n1. 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.\n2. 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.\n\nImplications and Relevance:\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No prior diagnosis of dementia\n* Live in Canada\n* 16 years of age and over\n* Good command of the English language\n* Access to email and internet\n* Comfortable using email and internet, and\n* Ability to grant online informed consent\n\nExclusion Criteria:\n\n* Prior diagnosis of dementia\n* Lives outside of Canada\n* Not 16 years of age or over\n* Does not speak English,\n* Does not have access to email or internet\n* Is not comfortable using email of internet\n* Does not grant informed consent'}, 'identificationModule': {'nctId': 'NCT05383118', 'briefTitle': 'e-Learning About Cognitive Impairment and Dementia Prevention', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Dementia Prevention Internet-Based Intervention: Randomized Controlled Trial and Knowledge Translation', 'orgStudyIdInfo': {'id': 'Levinson_ISFR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education Intervention', 'description': "Participants in the intervention group will be provided e-learning about dementia prevention and promoting brain health, consisting of following components:\n\n1. One multimedia e-learning lesson on promoting brain health and preventing dementia;\n2. A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson.\n3. Curated resources related to dementia risk factors", 'interventionNames': ['Behavioral: Education Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education Control', 'description': "Participants in the control group will be provided e-learning about mild cognitive impairment, consisting of following components:\n\n1. One multimedia e-learning lesson on mild cognitive impairment;\n2. A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson.\n3. Curated resources related to mild cognitive impairment", 'interventionNames': ['Behavioral: Education Control']}], 'interventions': [{'name': 'Education Intervention', 'type': 'BEHAVIORAL', 'description': "Participants in the intervention group will be provided e-learning about dementia prevention and promoting brain health, consisting of following components:\n\n1. One multimedia e-learning lesson on promoting brain health and preventing dementia;\n2. A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson.\n3. Curated resources related to dementia risk factors", 'armGroupLabels': ['Education Intervention']}, {'name': 'Education Control', 'type': 'BEHAVIORAL', 'description': "Participants in the control group will be provided e-learning about mild cognitive impairment, consisting of following components:\n\n1. One multimedia e-learning lesson on mild cognitive impairment;\n2. A series of 12 'micro-learning' emails (3 emails/week) with small segments of content to reinforce the material from the lesson.\n3. Curated resources related to mild cognitive impairment", 'armGroupLabels': ['Education Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 4L8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Agency of Canada (PHAC)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}