- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07377331
Exploration of an Online Education Program to Support Caregivers' Knowledge Transfer
January 22, 2026 updated by: Uma Tauber, Texas Christian University
Exploration of Structure Retrieval Practice to Support Caregivers' Knowledge Transfer
The overarching goal of this work is to determine methods that improve caregiver education about the behavioral and psychological symptoms (BPSD) of dementia.
The specific goal of this project is to extend our prior work to evaluate the impact of our educational intervention on caregivers' ability to transfer knowledge about the management of ADRD to real-world applied examples.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Uma Tauber, PhD
- Phone Number: 817-257-4295
- Email: memorylab@tcu.edu
Study Contact Backup
- Name: Robert Ariel, PhD
- Email: confidentcarestudy@gmail.com
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76129
- Recruiting
- Texas Christian University
-
Contact:
- Uma Tauber, PhD
- Phone Number: 817-257-4295
- Email: memorylab@tcu.edu
-
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Virginia
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Norfolk, Virginia, United States, 23502
- Not yet recruiting
- Virginia Wesleyan University
-
Contact:
- Robert Ariel, PhD
- Phone Number: 757-455-3288
- Email: confidentcarestudy@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- informal caregivers
- 18+ years old
- Read and speak English
- free of cognitive impairments that prevent consent and/or completing experimental tasks
- remote participants need access to a tablet, laptop, or desktop computer to complete tasks.
Exclusion Criteria:
- professional caregivers
- former caregivers who are not currently caring for someone living with dementia
- caregivers providing assistance to someone with normal cognition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Within-participant design with 2 learning conditions: intervention and reading control
For each caregiver participant, half of the BPSD categories (i.e., 4) will be randomly assigned to the structured retrieval practice (SRP) intervention, and the other half will be randomly assigned to the restudy control condition.
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Participants will complete self-paced practice tests for the 4 categories assigned to the SRP intervention.
Specifically, the practice test will consist of 24 total questions: 6 multiple-choice questions for each of the 4-categories - 3 questions on triggers and 3 questions on symptom management.
Each question will have 1 correct answer and 3 incorrect lures.
The vertical order of responses on the screen will be randomized per participant.
Questions will be presented in a blocked fashion such that participants will answer all 6 questions in one category (e.g., anxiety), in a random order, before moving to the next (e.g., hallucinations).
After each multiple-choice answer, participants will receive detailed, corrective feedback.
They will self-pace their study of feedback.
Participants will complete 3 practice retrieval blocks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immediate near transfer test performance
Time Frame: 10 minutes post-intervention (session 1)
|
proportion correct on the immediate (approx.
10 min retention interval) test of near transfer.
The test will include 48 questions and will be fill-in-the-blank format.
Performance will be explored via percent correct on the test and magnitude of the retrieval practice effect on the test.
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10 minutes post-intervention (session 1)
|
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immediate applied transfer test performance
Time Frame: approx. 10 minutes post-intervention (session 1)
|
proportion correct on the immediate (approx.
10 min retention interval) test to apply examples of symptoms of ADRD.
The test will include 8 questions and be short-answer format.
Performance will be explored via percent correct on the test and magnitude of the retrieval practice effect on the test.
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approx. 10 minutes post-intervention (session 1)
|
|
Delayed Near Transfer test performance
Time Frame: 2 days post-intervention (session 2)
|
proportion correct on the final 2-day delayed test of near transfer.
The test will include 48 questions and will be fill-in-the-blank format.
Performance will be explored via percent correct on the test, magnitude of the retrieval practice effect on the test, and amount of forgetting.
|
2 days post-intervention (session 2)
|
|
Delayed Applied Transfer test performance
Time Frame: 2 days post-intervention (session 2)
|
proportion correct on the final 2-day delayed test of transfer to apply examples of symptoms of ADRD.
The test will include 8 questions and be short-answer format.
Performance will be explored via percent correct on the test, magnitude of the retrieval practice effect on the test, and amount of forgetting.
|
2 days post-intervention (session 2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delayed knowledge test performance
Time Frame: 2 days post-intervention (session 2)
|
proportion correct on the final 2-day delayed test of symptoms of ADRD.
The test will include 48 questions and will be in multiple-choice format.
Performance will be explored via percent correct on the test, magnitude of the retrieval practice effect on the test, and amount of forgetting.
|
2 days post-intervention (session 2)
|
|
Immediate knowledge test performance
Time Frame: 10 minutes post-intervention (session 1)
|
proportion correct on the immediate (approx.
10 min retention interval) test of symptoms of ADRD.
The test will include 48 questions and will be in multiple-choice format.
Performance will be explored via percent correct on the test, magnitude of the retrieval practice effect on the test, and amount of forgetting.
|
10 minutes post-intervention (session 1)
|
|
Medical Health Knowledge
Time Frame: 2 days post-intervention (session 2)
|
Participants will complete the Medical Term Recognition Test (METER, Rawson et al., 2010).
The METER is completed on paper.
A list of 40 medical words and 40 nonwords are presented.
Participants read the list of items and select the ones that they recognize as real words.
Participants are instructed not to guess and to only select items they are sure were real words.
Performance on the METER is calculated as the number of words correctly recognized.
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2 days post-intervention (session 2)
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Demographic Characteristics
Time Frame: Baseline and 2 days later
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age, gender, education level, race/ethnicity, first generation status, member of an underrepresented group, native language, socioeconomic status, occupation, zip code, relationship with individual living with Alzheimer's Disease or a related dementia (e.g., child, spouse), caregiving status and duration of caregiving, and information seeking about dementia and caregiving.
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Baseline and 2 days later
|
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Self-reported Subjective health information
Time Frame: Baseline and 2 days later
|
Caregivers will self-report co-morbid medical conditions for the PLwD, and will report medication use, rating of health, hospitalizations, access to health insurance for the PLwD.
Caregivers will be allowed to skip any questions they desire should they prefer not to report responses to any of these questions.
No measurement scale will be used for these self-report questions.
Instead, these brief questions are intended to obtain general health information.
Example questions include, "does the person have other chronic conditions?" "Does the person living with dementia take any prescription medications?" and "Have you gone to the hospital emergency room (ER) about the person living with dementia's health in the past year (12 months)?" Responses to these questions will be used for descriptive purposes to better understand the sample and will not be aggregated into one measure.
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Baseline and 2 days later
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Symptom Presence, Severity, and Frequency
Time Frame: pre-intervention, measure occurs online during participant screening
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The behavioral and psychological symptoms experienced by the person living with dementia will be rated by the caregiver participants using the updated version of the Neuropsychiatric Inventory Questionnaire (NPI-Q; Cummings et al., 1994; Resnick et al., 2024; Resnick et al., 2021).
This measure includes 12 items that the participant will rate on presence (yes vs. no), severity (1 = mild, 2 = moderate, 3 = severe), and distress (1 = not distressing at all to 5 = extremely distressing).
Perceived symptom severity will be measured twice applying a pre-test post-test design.
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pre-intervention, measure occurs online during participant screening
|
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Performance During Learning
Time Frame: Baseline
|
Caregivers' performance during learning will be defined as the percent correct on retrieval practice trials.
Specifically, caregivers will respond to multiple choice questions during learning when engaging in retrieval practice, and learning progress will be quantified by aggregating responses across items for each block.
Each multiple choice question will have 1 correct answer and 3 incorrect lures, and responses will be scored as 1 (correct) or 0 (incorrect) and then aggregated per participant.
This is a quantitative measure that is standard in the science of learning and for which no validated scale is available.
Performance on retrieval practice trials for the will be evaluated with item-level analysis (to explore content difficulty) and across each learning block to establish participants' rate-of-learning.
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Baseline
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Raven's Progressive Matrices
Time Frame: immediately following intervention during session 1
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Non-verbal fluid intelligence will be assessed with a computerized version of Raven's progressive matrices (Raven, et al., 1998).
Participants will complete 18 trials in ascending order in trial normative difficulty (Ariel, Babineau, & Tauber, 2023; adapted from Stanovich & Cunningham, 1993).
For each trial, a 3 x 3 array will be displayed with 8 geometric figures.
The 9th position in the bottom right-hand corner will be empty.
Participants will be given 8 geometric figures from which to choose to correctly complete the array.
Participants will be given 10 minutes to complete as many trials as possible.
Performance will be calculated as the total number of trials correct.
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immediately following intervention during session 1
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Verification of Alzheimer's Disease or Related Dementia (ADRD)
Time Frame: participant screening, pre-intervention
|
Verification of ADRD symptoms for each caregiver's person living with dementia (PLwD) is critical to confirm authentic caregiving.
We will use the Ascertain Dementia 8 (AD8; Galvin et al., 2005), a validated informant interview sensitive to early cognitive change with strong predictive accuracy (AUC = .83),
diagnostic accuracy (AUC = .92;
Chen et al., 2018), and cross-cultural validation (Dominguez et al., 2021; Ismail et al., 2021; Meguro et al., 2015).
The 3-minute interview will be conducted in-person or via video call.
Caregivers answer 8 questions (e.g., Has there been a change in the last several years caused by cognitive (thinking and memory) problems?
Have there been problems with judgments (e.g., falls for scams, bad financial decisions, buys gifts inappropriate for recipients) in the last several years?) by responding, yes, no, or N/A (don't know).
Scores (0-8) sum affirmative responses; higher scores indicate more impairment.
A cutoff ≥ 2 indicates high probability of carin
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participant screening, pre-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2025
Primary Completion (Estimated)
August 15, 2026
Study Completion (Estimated)
August 15, 2026
Study Registration Dates
First Submitted
January 14, 2026
First Submitted That Met QC Criteria
January 22, 2026
First Posted (Actual)
January 29, 2026
Study Record Updates
Last Update Posted (Actual)
January 29, 2026
Last Update Submitted That Met QC Criteria
January 22, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-153-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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