DementiaPhase 1NCT07377331
Exploration of an Online Education Program to Support Caregivers' Knowledge Transfer
A Phase 1 study testing Structured Retrieval Practice (SRP) in people with Dementia, run by Texas Christian University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Structured Retrieval Practice (SRP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2025to 15 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- professional caregivers
- former caregivers who are not currently caring for someone living with dementia
- caregivers providing assistance to someone with normal cognition
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Robert Ariel, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Texas Christian University
Fort Worth, Texas, 76129
Uma Tauber, PhD, 817-257-4295, memorylab@tcu.edu
- Not yet recruiting
Virginia Wesleyan University
Norfolk, Virginia, 23502
Robert Ariel, PhD, 757-455-3288, confidentcarestudy@gmail.com
About this study
Official title: 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.
- Conditions
- Dementia
- Being tested
- Structured Retrieval Practice (SRP)
- Keywords
- dementia, caregiving, knowledge, transfer, behaviorial problems
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Retrieval Practice (SRP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Within-participant design with 2 learning conditions: intervention and reading control | Experimental | 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. Receives: Behavioral: Structured Retrieval Practice (SRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate near transfer test performance
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.
Measured: 10 minutes post-intervention (session 1)
immediate applied transfer test performance
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.
Measured: approx. 10 minutes post-intervention (session 1)
Delayed Near Transfer test performance
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.
Measured: 2 days post-intervention (session 2)
Delayed Applied Transfer test performance
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.
Measured: 2 days post-intervention (session 2)
Secondary outcomes (8)
Delayed knowledge test performance
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.
Measured: 2 days post-intervention (session 2)
Immediate knowledge test performance
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.
Measured: 10 minutes post-intervention (session 1)
Medical Health Knowledge
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.
Measured: 2 days post-intervention (session 2)
Demographic Characteristics
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.
Measured: Baseline and 2 days later
Self-reported Subjective health information
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.
Measured: Baseline and 2 days later
Symptom Presence, Severity, and Frequency
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.
Measured: pre-intervention, measure occurs online during participant screening
Performance During Learning
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.
Measured: Baseline
Raven's Progressive Matrices
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.
Measured: immediately following intervention during session 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Nov 2025
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Longitudinal, behavioral intervention, randomized controlled trial with crossover assignment to condition (SRP vs. Active Control Comparison). Individual-level random assignment will occur for order of the conditions.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uma Tauber, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377331
- Sponsor's protocol ID
- 2024-153-4
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Structure Retrieval Practice to Support Caregivers' Knowledge Transfer
- ClinicalTrials.gov ID
- NCT07377331
- Acronym / sponsor ID
- 2024-153-4
- Conditions
- Dementia
- Keywords
- dementia, caregiving, knowledge, transfer, behaviorial problems
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal, behavioral intervention, randomized controlled trial with crossover assignment to condition (SRP vs. Active Control Comparison). Individual-level random assignment will occur for order of the conditions.
| Arm | Type | Receives |
|---|---|---|
| Within-participant design with 2 learning conditions: intervention and reading control | Experimental | Behavioral: Structured Retrieval Practice (SRP)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- professional caregivers
- former caregivers who are not currently caring for someone living with dementia
- caregivers providing assistance to someone with normal cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Retrieval Practice (SRP)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. | Behavioural | Within-participant design with 2 learning conditions: intervention and reading control |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
Delayed knowledge test performance
Time frame: 2 days post-intervention (session 2)
Immediate knowledge test performance
Time frame: 10 minutes post-intervention (session 1)
Medical Health Knowledge
Time frame: 2 days post-intervention (session 2)
Demographic Characteristics
Time frame: Baseline and 2 days later
Self-reported Subjective health information
Time frame: Baseline and 2 days later
Symptom Presence, Severity, and Frequency
Time frame: pre-intervention, measure occurs online during participant screening
Performance During Learning
Time frame: Baseline
Raven's Progressive Matrices
Time frame: immediately following intervention during session 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Ariel, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Structured Retrieval Practice (SRP) in people with Dementia, run by Texas Christian University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uma Tauber, PhD (817-257-4295, memorylab@tcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate near transfer test performance (time frame: 10 minutes post-intervention (session 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.