An interventional study of Education Intervention and Education Control in Dementia, Burden, Caregiver and Self Efficacy, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by McMaster University · Not applicable, Interventional, and Other
With the aging population, the prevalence of dementia is increasing dramatically. People living with dementia are highly dependent on family care partners, who may have little knowledge of the disorder. National and provincial guidelines have all highlighted the importance of online resources to improve care partner education; however, very few have been widely implemented or rigorously studied.
The investigators have developed the award-winning dementia education platform to complement traditional patient and family educational approaches. It allows free access to multimedia e-learning lessons, live expert webinars, and email-based content that care partners can access any time, anywhere.
In a pilot randomized controlled trial (RCT), the investigators propose to study 1) the feasibility and care partner acceptance of the intervention and some of the study methods, and 2) the impact of the intervention on care partner self-efficacy, knowledge, and sense of burden.
This initiative has the potential to improve the quality, cost effectiveness, and efficiency of dementia care. The intervention could be easily scaled and spread both provincially and nationally to complement other dementia education methods, at a time when the prevalence of dementia is increasing and access to high quality internet-based interventions is essential.
2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's enrollment of 125 is above the median of 83 across 1,669 interventional studies indexed under Dementia.
Browse Dementia studies →McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Education Intervention
Other: Education Control
Participants in the intervention group will be provided e-learning about dementia and promoting brain health, consisting of the following components: 1. Ten selected multimedia e-learning lessons; 2. A series of 16 'micro-learning' emails (2 emails/week) with small segments of content to reinforce the material from the lessons. Participants will have 8-weeks to complete the intervention. The total time to complete is approximately 5-6 hours.
Participants in the control group will be provided e-learning about dementia and promoting brain health, consisting of the following components: 1. One selected multimedia e-learning lesson; 2. A series of 16 'micro-learning' emails (2 emails/week) with small segments of content to reinforce the material from the lessons. Participants will have 8-weeks to complete. The total time to complete is approximately 1-2 hours. Note: All participants will receive access to all e-learning at the conclusion of the study.
Intervention adherence (time spent)
Lesson completed data and email open rates will be collected and saved to quantify the time(s) spent on intervention activities.
Time frame: 8 weeks
Participant satisfaction
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: 8 weeks
Participant satisfaction
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: 8 weeks
Recruitment rates
Participant recruitment numbers will be collected and saved to quantify the number of interested participants.
Time frame: 8 weeks
Attrition rates
Participant attrition rates will be collected and saved to quantify the number of study dropouts vs completions
Time frame: 8 weeks
Change from baseline in the Revised Scale for Caregiving Self-Efficacy (RSCSE) at 8 weeks.
Self-efficacy will be measured through the Revised Scale for Caregiving Self-Efficacy (RSCSE) (reliability α = \>.80). The RSCSE contains 15 items within 3 subscales (self-efficacy for obtaining respite, responding to disruptive patient behaviours, and controlling upsetting thoughts about caregiving). Higher scores indicate a higher level of self-efficacy.
Time frame: 0, 8 weeks
Change from baseline in the Dementia Knowledge Assessment Scale (DKAS) at 8 weeks.
Knowledge will be measured through the Dementia Knowledge Assessment Scale (DKAS) (reliability α = .85; ωh = .87; overall scale). The DKAS consists of 25 items on different aspects of dementia that could be answered with 'True,' 'Probably True,' 'False, 'Probably False,' or 'I don't know.' Higher scores indicate a higher level of dementia knowledge.
Time frame: 0, 8 weeks
Change from baseline in the Zarit Burden Interview (ZBI) at 8 weeks.
Burden will be measured through the Zarit Burden Interview (ZBI) (reliability α = .92). The ZBI contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Higher scores indicate a higher level of burden.
Time frame: 0, 8 weeks
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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