- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05114187
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4L8
- McMaster University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Education Intervention
|
Participants in the intervention group will be provided e-learning about dementia and promoting brain health, consisting of the following components:
Participants will have 8-weeks to complete the intervention. The total time to complete is approximately 5-6 hours. |
Active Comparator: Education Control
|
Participants in the control group will be provided e-learning about dementia and promoting brain health, consisting of the following components:
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)
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
Participant recruitment numbers will be collected and saved to quantify the number of interested participants.
|
8 weeks
|
Attrition rates
Time Frame: 8 weeks
|
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.
Time Frame: 0, 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.
Time Frame: 0, 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.
Time Frame: 0, 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
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #21-24
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden
Clinical Trials on Education Intervention
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Institute on Minority Health and...RecruitingHuman Papillomavirus InfectionUnited States
-
Ohio State University Comprehensive Cancer CenterRecruitingMalignant Solid Neoplasm | Hematopoietic and Lymphoid System NeoplasmUnited States
-
Thomas Jefferson UniversityNot yet recruitingMetastatic Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8United States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Melanoma Research FoundationRecruiting
-
Mayo ClinicActive, not recruiting
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityTerminatedMalignant NeoplasmUnited States
-
University of WashingtonNational Institute of Nursing Research (NINR)RecruitingMalignant Solid Neoplasm | Cancer | Parent-Child Relations | Parenting | Hematopoietic and Lymphoid System Neoplasm | SurvivorshipUnited States
-
Fred Hutchinson Cancer CenterPrevent Cancer FoundationCompleted
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Ohio State University Comprehensive Cancer CenterCompleted