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

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.

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Self Efficacy; Knowledge; Burden, Caregiver
• Intervention / Treatment: Other: Education Intervention; Other: Education Control

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4L8
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education Intervention	Other: Education Intervention; Participants in the intervention group will be provided e-learning about dementia and promoting brain health, consisting of the following components: Ten selected multimedia e-learning lessons;; 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.
Active Comparator: Education Control	Other: Education Control; Participants in the control group will be provided e-learning about dementia and promoting brain health, consisting of the following components: One selected multimedia e-learning lesson;; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rates	Participant recruitment numbers will be collected and saved to quantify the number of interested participants.	8 weeks
Attrition rates	Participant attrition rates will be collected and saved to quantify the number of study dropouts vs completions	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.	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.	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.	0, 8 weeks

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: The Physicians' Services Incorporated Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): September 5, 2023
• Study Completion (Actual): September 5, 2023

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Web-based intervention; Dementia; Caregiver; Clinical Trial; Knowledge Translation; Internet; Alzheimer disease; E-health; Education and Training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Stress, Psychological; Dementia; Caregiver Burden
• Other Study ID Numbers: #21-24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No