NCT05114187

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

October 15, 2021

Last Update Submit

October 17, 2023

Conditions

DementiaBurden, CaregiverSelf EfficacyKnowledge

Keywords

Web-based interventionInternetE-healthDementiaCaregiverAlzheimer diseaseEducation and TrainingClinical TrialKnowledge Translation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    8 weeks

Secondary Outcomes (5)

  • Recruitment rates

    8 weeks

  • Attrition rates

    8 weeks

  • Change from baseline in the Revised Scale for Caregiving Self-Efficacy (RSCSE) at 8 weeks.

    0, 8 weeks

  • Change from baseline in the Dementia Knowledge Assessment Scale (DKAS) at 8 weeks.

    0, 8 weeks

  • Change from baseline in the Zarit Burden Interview (ZBI) at 8 weeks.

    0, 8 weeks

Study Arms (2)

Education Intervention

EXPERIMENTAL
Other: Education Intervention

Education Control

ACTIVE COMPARATOR
Other: Education Control

Interventions

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 Intervention
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.

Education Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 40466093DERIVED

MeSH Terms

Conditions

DementiaCaregiver BurdenAlzheimer Disease

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehaviorTauopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study is a two-arm pilot randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2021

First Posted

November 9, 2021

Study Start

September 6, 2022

Primary Completion

September 5, 2023

Study Completion

September 5, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Locations

CA(1)