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DementiaPhase 1NCT07381010

Learn About Caring for a Person Living With Dementia

A Phase 1 study testing Structured Retrieval Practice (SRP) and Standard Health Education in people with Dementia, run by Texas Christian University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of is project is to improve caregiver education about the behavioral and psychological symptoms (BPSD) of dementia. This intervention will incorporate principles from the science of learning for structuring retrieval practice to optimize learning and long-term retention of key health information. 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) and Standard Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
2 sitesUnited States
Study dates
1 Jan 2025to 31 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Caregiver for a person living with dementia
  • Read and speak English
  • Free from cognitive impairments that prevent consenting or completing experimental tasks

Who cannot join

  • Technology issues (e.g., loss of internet connection)
  • Not finishing the study
  • Significant distractions
  • Failing 2 or more attention or bot checks
  • Response times 3+ standard deviations from the mean for time sensitive measures
  • Completing session 1 in less than 1 hour

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Texas Christian University

    Fort Worth, Texas, 76129

  • Virginia Wesleyan University

    Norfolk, Virginia, 23502

Other trials in United States

About this study

Official title: Caregivers' Transfer of Dementia Knowledge as Supported by Structured Retrieval Practice

The goal of is project is to improve caregiver education about the behavioral and psychological symptoms (BPSD) of dementia. This intervention will incorporate principles from the science of learning for structuring retrieval practice to optimize learning and long-term retention of key health information. The processing-knowledge model for ADRD care predicts that enhancing health knowledge using structured retrieval practice will best support caregivers of people living with dementia (PLwD).

Read the detailed description

This study consisted of a screener and two sessions. Participants began by answering screener questions to see if they qualified to participate in the study. In Session 1, participants completed measures of self-efficacy and dementia symptom severity at their own pace. Next, participants studied 4 categories of emotions and mood symptoms of ADRD (agitation, irritation, apathy, depression) in a webpage format, as would be available from online resources (e.g., National Institutes of Health) to mirror caregivers often obtain information. Study was self-paced and order of topics was randomized. Following study, caregivers were randomly assigned to the restudy group or the structured retrieval group. Those in the restudy group restudied the four categories in the same format as before, at their own pace. Those in the structured retrieval group took a self-paced practice test consisting of 8 multiple-choice questions for each of the 4-categories in a blocked fashion such that participants answered all 8 questions in one category, in a random order (e.g., apathy), before moving onto the next (e.g., agitation), and received detailed, corrective feedback following each answer to the multiple-choice questions. Participants either studied or practice retrieval for 3 practice blocks. The order of categories and questions was randomized for each participant during each practice block. Following practice, participants completed the 10-minute problem solving task. Participants then took a self-paced multiple-choice test consisting of all 32 multiple-choice questions (i.e., the same questions as in practice). After the test, participants completed a self-paced usability measure and provided demographic information.

Session 2 began two days later, and participants began by taking the same self-paced multiple-choice test as in Session 1. Next, they completed a vocabulary task, self-efficacy scale, dementia symptom severity scale, measure of health knowledge, information seeking, and provide demographic information. Finally, participants were thanked, debriefed, and compensated for their participation.

Conditions
Dementia
Being tested
Structured Retrieval Practice (SRP), Standard Health Education
Keywords
dementia care, symptoms of dementia, caregiver knowledge
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

    Our Structured Retrieval Practice (SRP) Caregiver Intervention is a web-based multi-media program designed to enhance dementia caregivers' goal-relevant memory, reduce caregiver stress, and reduce perceptions of symptom severity. The self-guided online intervention does not require supervision by a healthcare professional. Caregivers learn modules on dementia care and complete dynamic multiple-choice tests targeting practical knowledge supported with detailed, elaborative feedback to correct health misconceptions.

  • Standard Health EducationBehavioural

    Caregivers re-read modules on Alzheimer's Disease or related dementias (ADRD) in a webpage format, as would be available from online resources (e.g., National Institutes of Health) to mirror how most caregivers obtain information.

Study groups in NCT07381010
Study groupRoleWhat they receive
Structured Retrieval Practice (SRP) interventionExperimentalNot described
Receives: Behavioral: Structured Retrieval Practice (SRP)
Active Control ComparisonActive comparatorRereading
Receives: Behavioral: Standard Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delayed test performance

    Proportion correct on the final 2-day delayed test of symptoms and treatments of ADRD. The test was in multiple-choice format. Performance was explored via percent correct on the test, magnitude of the retrieval practice effect on the test, and amount of forgetting.

    Measured: 2 days after baseline

  2. Immediate test performance

    Proportion correct on the immediate (approx. 10 min retention interval) test of symptoms and treatments of ADRD. The test was multiple-choice format. Performance was explored via percent correct on the test, magnitude of the retrieval practice effect on the test, and amount of forgetting.

    Measured: Baseline

Secondary outcomes (12)
  1. Caregiver Self-efficacy

    Caregiver self-efficacy for symptom management will be measured using the symptom subscale of the Family Caregiver Self-efficacy for Dementia Scale (Fortinsky, Kercher, \& Burant, 2002), which includes 5 items. An example item is, "how certain are you right now that you can handle any problems your relative has, like memory loss, wandering, or behavior problems." Responses will be given using a 1 (not at all certain) to 10 (very certain) scale. We will expand this scale to include items that match with our content and our symptom presence, severity, and frequency measure. Specifically, participants will respond to 12 questions using a scale from 1 (not at all certain) to 10 (very certain). An example item is, "how certain are you right now that you can handle when your loved one living with dementia experiences false beliefs or delusions?" Caregiver self-efficacy will be measured twice applying a pre-test post-test design.

    Measured: pre-intervention and 2-days post baseline

  2. E-Health Literacy

    The E-health Literacy Scale (eHEALS) Norman \& Skinner, 2006 will be administered to assess perceived skills and comfort related to using internet resources for acquiring health knowledge. The scale includes 10 questions (e.g., I can tell high quality from low quality health resources on the internet). Questions require responding on a Likert sale ranging from 1 to 5 (1-strongly disagree, 2- disagree, 3-undecided, 4-agree, 5-strongly agree; 1-not useful at all, 2-not useful, 3-unsure, 4-useful, 5-very useful; or 1-not important at all, 2-not important, 3-unsure, 4-important, 5-very important). Composite scores will be calculated with higher scores indicate higher e-health literacy.

    Measured: 2 days after baseline

  3. Letter and pattern comparison

    Perceptual speed will be measured with the Letter Comparison Test and Pattern Comparison Test (Salthouse, 1993). The Letter Comparison Test involves 21 letter string pairs to be judged as the same or different. The Pattern Comparison Test involves 30 line patterns to be judged as the same or different. For both comparison tests, participants are given 24 seconds per test to complete as many items as possible, and performance is calculated as the number of items correct. Performance on each test will be calculated as the number of items correct, and a composite score will be calculated per participant.

    Measured: 2 days after baseline

  4. 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: Baseline

  5. Vocabulary

    General knowledge will be assessed using a common measure of general knowledge in cognitive aging research, the Advanced Vocabulary Test I-v-4 (Ekstrom et al., 1976). Participants will be presented with a series of words and required to select the synonym for each word out of five options. Participants are given 4 min per task to complete as many words as possible (36 total problems, 8 min total). The self-paced vocabulary test is presented in a fixed order, and no feedback is provided. Performance is calculated as the number of items correct while adjusting for guessing (i.e., number of items correct - (.2 * number of items incorrect)).

    Measured: 2 days after baseline

  6. 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 after Baseline

  7. Dementia Health Knowledge

    The Alzheimer's Disease Knowledge Scale (ADKS, Carpenter et al., 2009) will be administered, and scale composite score will be calculated. The ADKS is a 30-item true/false that has been adapted cross-culturally and used to estimate knowledge of people with varying expertise in Alzheimer's Disease. It includes 4 symptom statements (e.g., Tremor or shaking of the hands or arms is a common symptom in people with AD - False), 5 caregiving statements (e.g., People with AD do best with simple instructions giving one step at a time - True), and 4 treatment and management statements (e.g., Poor nutrition can make the symptoms of AD worse - True). Participants respond by indicating true, false, or don't know.

    Measured: 2 days after Baseline

  8. 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

  9. Usability Measures

    The Perceived Usefulness (PU), Ease of Use (PEUO), Enjoyment (PNJ), Behavioral Intentions (BI), Relevance, and Output Quality (OUT) subscales of the Technology Acceptance Model (TAM) 3 scale (Venkatesh \& Bala, 2008) will be administered, and scale composite score will be calculated. The subscales include 3 to 4 items. An example item from the Ease of Use scale is, "I find this system easy to use." An example item from the Enjoyment scale is, "The actual process of using the system is pleasant." Questions will be adapted for our sample. For instance, questions like, "Using the system improves my performance in my job", will be altered to read, "Using the program improves my ability to manage symptoms for an individual living with dementia." Responses to all questions will be made on a 7-point Likert scale from strongly disagree to strongly agree.

    Measured: Baseline

  10. 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 at Baseline and 2 days after Baseline

  11. 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 after Baseline

  12. 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 after Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2026
  2. Study start1 Jan 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

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
Parallel groups
Model description
Randomized controlled trial with caregivers randomly assigned to either the treatment (intervention) or active control comparison.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07381010
Sponsor's protocol ID
2024-153b
Status last verified
Jan 2026
First submitted
24 Jan 2026
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Structured Retrieval Practice (SRP) and Standard Health Education 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 2 Feb 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delayed test performance (time frame: 2 days after baseline). The study lists 2 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 2 Feb 2026.

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