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DementiaNCT05114187

An Internet-Based Education Program for Care Partners of People Living With Dementia

A study testing Education Intervention in people with Dementia and Burden, Caregiver, 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

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia, Burden, Caregiver, Self Efficacy
What is being tested?
Education Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteCanada
Study dates
6 Sep 2022to 5 Sep 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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • they are a family and/or friend care partner of a person living with dementia,
  • they reside in Canada,
  • they are 18 years of age and over,
  • they have a good command of the English language,
  • they have access to email and internet,
  • they are comfortable using email and internet,
  • they have the ability to grant online informed consent, and
  • they complete online baseline assessments.

Who cannot join

  • they are a not family and/or friend care partner of a person living with dementia,
  • they do not reside in Canada,
  • they are not 18 years of age and over,
  • they do not have a good command of the English language,
  • they do not have access to email and internet,
  • they are not comfortable using email and internet,
  • they do not have the ability to grant online informed consent, and
  • they do not complete online baseline assessments.

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: An Internet-Based Education Program for Care Partners of People Living With Dementia (iGeriCare): A Pilot Randomized Controlled Trial

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.

Read more

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.

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

What participants receive

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

  • Education InterventionOther

    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.

  • Education ControlOther

    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.

Study groups in NCT05114187
Study groupRoleWhat they receive
Education InterventionExperimentalNot described
Receives: Other: Education Intervention
Education ControlActive comparatorNot described
Receives: Other: Education Control

What is being measured

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

  1. 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.

    Measured: 8 weeks

  2. 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.

    Measured: 8 weeks

  3. 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.

    Measured: 8 weeks

Secondary outcomes (5)

  1. Recruitment rates

    Participant recruitment numbers will be collected and saved to quantify the number of interested participants.

    Measured: 8 weeks

  2. Attrition rates

    Participant attrition rates will be collected and saved to quantify the number of study dropouts vs completions

    Measured: 8 weeks

  3. 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.

    Measured: 0, 8 weeks

  4. 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.

    Measured: 0, 8 weeks

  5. 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.

    Measured: 0, 8 weeks

Timeline

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

  1. First posted9 Nov 2021
  2. Study start6 Sep 2022
  3. Primary completion5 Sep 2023
  4. Study completion5 Sep 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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a two-arm pilot randomized controlled trial.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05114187
Sponsor's protocol ID
#21-24
Status last verified
Oct 2023
First submitted
15 Oct 2021
Last updated
19 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Levinson AJ, Ayers S, Clark S, Woodburn R, Markle-Reid M, McKenna B, Oliver D, Papaioannou A, Siu H, Sztramko R. Web-Based Education Program for Care Partners of People Living With Dementia (iGeriCare): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 4;14:e67048. doi: 10.2196/67048.

    PubMed 40466093

Questions about this trial

What is this clinical trial studying?

A study testing Education Intervention in people with Dementia and Burden, Caregiver, 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 8 inclusion and 8 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 19 Oct 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?

Intervention adherence (time spent) (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 NCT05114187, 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 19 Oct 2023.

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