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

Primary Purpose

Dementia, Burden, Caregiver, Self Efficacy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Education Intervention
Education Control
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dementia focused on measuring Web-based intervention, Internet, E-health, Dementia, Caregiver, Alzheimer disease, Education and Training, Clinical Trial, Knowledge Translation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Education Intervention

Education Control

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Recruitment rates
Participant recruitment numbers will be collected and saved to quantify the number of interested participants.
Attrition rates
Participant attrition rates will be collected and saved to quantify the number of study dropouts vs completions
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.
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.
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.

Full Information

First Posted
October 15, 2021
Last Updated
October 17, 2023
Sponsor
McMaster University
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05114187
Brief Title
An Internet-Based Education Program for Care Partners of People Living With Dementia
Official Title
An Internet-Based Education Program for Care Partners of People Living With Dementia (iGeriCare): A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
September 5, 2023 (Actual)
Study Completion Date
September 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Burden, Caregiver, Self Efficacy, Knowledge
Keywords
Web-based intervention, Internet, E-health, Dementia, Caregiver, Alzheimer disease, Education and Training, Clinical Trial, Knowledge Translation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a two-arm pilot randomized controlled trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education Intervention
Arm Type
Experimental
Arm Title
Education Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Education Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Education Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intervention adherence (time spent)
Description
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
Title
Participant satisfaction
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.
Time Frame
8 weeks
Title
Participant satisfaction
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Recruitment rates
Description
Participant recruitment numbers will be collected and saved to quantify the number of interested participants.
Time Frame
8 weeks
Title
Attrition rates
Description
Participant attrition rates will be collected and saved to quantify the number of study dropouts vs completions
Time Frame
8 weeks
Title
Change from baseline in the Revised Scale for Caregiving Self-Efficacy (RSCSE) at 8 weeks.
Description
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
Title
Change from baseline in the Dementia Knowledge Assessment Scale (DKAS) at 8 weeks.
Description
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
Title
Change from baseline in the Zarit Burden Interview (ZBI) at 8 weeks.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada

12. IPD Sharing Statement

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

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