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DementiaPhase 1NCT07377318

Project CARE-D - Online Caregiver Education for Dementia

A Phase 1 study testing Structured Retrieval Practice, Business as usual learning and Standard Retrieval Practice in people with Dementia, run by Texas Christian University at 1 site 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

Managing daily symptoms for people with Alzheimer's Disease or Related Dementia (ADRD) can be challenging and confusing for informal caregivers who are family members or friends and not paid for their assistance. This is due, in part, to gaps in knowledge. 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, Business as usual learning and Standard Retrieval Practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
1 May 2025to 31 Aug 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

  • informal caregivers
  • located in the United States
  • Speak and read English
  • free of cognitive deficits that would prevent consenting and/or completing online experimental tasks

Who cannot join

  • formal caregivers
  • former caregivers who are not currently in a care role for a person living with dementia
  • technology issues that cause loss of data (e.g., internet connection failure)
  • not finishing the experiment
  • significant distractions during experimental tasks
  • failure to pass attention or bot checks

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Texas Christian University

    Fort Worth, Texas, 76129

Other trials in United States

About this study

Official title: Methods to Enhance Caregivers' Knowledge of Alzheimer's Disease and Related Dementias (ADRD)

Managing daily symptoms for people with Alzheimer's Disease or Related Dementia (ADRD) can be challenging and confusing for informal caregivers who are family members or friends and not paid for their assistance. This is due, in part, to gaps in knowledge. Ensuring that informal caregivers are properly educated about ADRD symptoms and treatment guidelines is an essential first step for reducing adverse health events that people living with ADRD experience and addressing the substantial emotional and physical burden that caregivers report. The goal of is project is to improve caregiver education to support treatment adherence for ADRD with retrieval practice. This intervention incorporates principles from the science of learning for structuring retrieval practice to optimize learning and that are effective across the lifespan to compensate for gaps in knowledge and processing capabilities including learners who experience associative memory deficits due to age, their own disease state, or other factors.

Conditions
Dementia
Being tested
Structured Retrieval Practice, Business as usual learning, Standard Retrieval Practice
Keywords
dementia care
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 PracticeBehavioural

    The primary learning principle driving the proposed learning intervention is retrieval practice. The efficacy of spaced retrieval practice for learning is supported by a large and robust literature. Accurately recalling information during practice increases the probability that information will be accessible later when the stakes are higher. Caregivers studied all 12 BPSD in the learning phase, at their own pace, and then completed retrieval practice trials by answering multiple choice questions. Each multiple choice question had 1 correct answer and 3 incorrect lures. Detailed, corrective, and elaborative feedback was provided after each response to reinforce correct answers and correct wrong responses. The order of learning strategy was randomized per caregiver, and caregivers went through the learning phase a total of three times. Strategy was consistent between trials.

  • Business as usual learningBehavioural

    Caregivers were informed that they would read about 12 BPSD and that they should try their best to read each text as if they were researching the material on their own. Caregivers then studied each of the 12 BPSD, one-by-one, in a webpage format, at their own pace.

  • Standard Retrieval PracticeBehavioural

    Caregivers completed retrieval practice trials during learning by responding to multiple choice questions each with 1 correct answer and 3 incorrect lures. No feedback was provided following their response selections.

Study groups in NCT07377318
Study groupRoleWhat they receive
Structured Retrieval Practice (SRP)ExperimentalNot described
Receives: Behavioral: Structured Retrieval Practice
Standard Retrieval PracticeActive comparatorNot described
Receives: Behavioral: Standard Retrieval Practice
Self-paced StudyActive comparatorNot described
Receives: Behavioral: Business as usual learning

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 will be in multiple-choice format.

    Measured: 2 days following first session

  2. Immediate test performance

    proportion correct on the immediate (approx. 10 min retention interval) test of symptoms and treatments of ADRD. The test will be in multiple-choice format.

    Measured: at the end of the first session; 10 minutes post-intervention

Secondary outcomes (11)
  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, 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?"

    Measured: 2 days following intervention (i.e., session 2 measure)

  2. E-Health Literacy

    The E-health Literacy Scale (eHEALS) 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 following intervention (i.e., session 2 measure)

  3. Letter and pattern comparison

    Perceptual speed will be measured with the Letter Comparison Test and Pattern Comparison Test. 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 following intervention (i.e., session 2 measure)

  4. Raven's progressive matrices

    Non-verbal fluid intelligence will be assessed with a computerized version of Raven's progressive matrices. Participants will complete 18 trials in ascending order in trial normative difficulty . 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 the intervention

  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 . 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 following intervention (i.e., session 2 measure)

  6. Medical health knowledge

    Participants will complete the Medical Term Recognition Test. 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 following intervention (i.e., session 2 measure)

  7. 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

  8. 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). 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).

    Measured: 2 days following intervention (i.e., session 2 measure)

  9. Usability measures

    The Technology Acceptance Model (TAM) 3 scale will be administered, and scale composite score will be calculated. Example items are, "I find this system easy to use." and "The actual process of using the system is pleasant." Minor adaptations will be implemented to ensure questions are applicable to dementia care. Responses to all questions will be made on a 7-point Likert scale from strongly disagree to strongly agree.

    Measured: Baseline

  10. Demographic characteristics

    This is not a scale measure, and no composite score or subscores are calculated. Instead, these are descriptive data about the sample so they are accurately described for considerations of generalizability. Questions include: age, gender, education level, race/ethnicity, first generation status, member of an underrepresented group, native language, socioeconomic status, occupation, relationship with individual living with Alzheimer's Disease or a related dementia (e.g., child, spouse), information seeking about dementia and caregiving, and duration of caregiving

    Measured: Baseline and 2 days following baseline

  11. 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

Timeline

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

  1. First posted29 Jan 2026
  2. Study start1 May 2025
  3. Primary completion31 Aug 2025
  4. Study completion31 Aug 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
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07377318
Sponsor's protocol ID
2024-153
Status last verified
Feb 2026
First submitted
14 Jan 2026
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Fortinsky RH, Kercher K, Burant CJ. Measurement and correlates of family caregiver self-efficacy for managing dementia. Aging Ment Health. 2002 May;6(2):153-60. doi: 10.1080/13607860220126763.

    PubMed 12028884
  • Venkatesh, V., & Bala, H. (2008). Technology Acceptance Model 3 and a Research Agenda on Interventions. Decision Sciences, 39(2), 273-315. doi: 10.1111/j.1540-5915.2008.00192.x

  • Ariel R, Babineau A, Tauber SK. Teaching older adults to use retrieval practice improves their self-regulated learning. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2024 Sep;31(5):823-845. doi: 10.1080/13825585.2023.2271531. Epub 2023 Oct 17.

    PubMed 37847784
  • Stanovich, K. E., & Cunningham, A. E. (1993). Where does knowledge come from? Specific associations between print exposure and information acquisition. Journal of Educational Psychology, 85(2), 211. doi: 10.1037/0022-0663.85.2.211

  • Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.

    PubMed 11001602
  • Salthouse, T. A., & Babcock, R. L. (1991). Decomposing adult age differences in working memory. Developmental Psychology, 27(5), 763-776. doi: 10.1037/0012-1649.27.5.763.

  • Rawson KA, Gunstad J, Hughes J, Spitznagel MB, Potter V, Waechter D, Rosneck J. The METER: a brief, self-administered measure of health literacy. J Gen Intern Med. 2010 Jan;25(1):67-71. doi: 10.1007/s11606-009-1158-7. Epub 2009 Nov 3.

    PubMed 19885705
  • Ekstrom, R. B., French, J. W., Harmon, H. H., & Dermen, D. (1976). Manual for kit of factor-referenced cognitive tests. Educational Testing Service.

  • Raven, J., Raven, J. C., & Court, J. H. (1998). Raven manual section 4: Advanced progressive matrices. Oxford. Oxford University Press.

  • Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006 Nov 14;8(4):e27. doi: 10.2196/jmir.8.4.e27.

    PubMed 17213046
  • Woods SP, Babicz MA, Matchanova A, Sullivan KL, Avci G, Hasbun R, Giordano TP, Fazeli P, Morgan EE. A Clinical Pilot Study of Spaced Retrieval Practice with a Self-Generation Booster to Improve Health-Related Memory in Persons With HIV Disease. Arch Clin Neuropsychol. 2021 Oct 13;36(7):1296-1306. doi: 10.1093/arclin/acaa130.

    PubMed 33517368
  • Tse CS, Balota DA, Roediger HL 3rd. The benefits and costs of repeated testing on the learning of face-name pairs in healthy older adults. Psychol Aging. 2010 Dec;25(4):833-45. doi: 10.1037/a0019933.

    PubMed 20718541
  • Sumowski JF, Wood HG, Chiaravalloti N, Wylie GR, Lengenfelder J, DeLuca J. Retrieval practice: a simple strategy for improving memory after traumatic brain injury. J Int Neuropsychol Soc. 2010 Nov;16(6):1147-50. doi: 10.1017/S1355617710001128. Epub 2010 Oct 15.

    PubMed 20946709
  • Ringer, T. J., Wong-Pack, M., Miller, P., Patterson, C., Marr, S., Misiaszek, B., Woo, T., Sztramko, R., Vastis, P. G., & Papaioannou, A. (2020). Understanding the educational and support needs of informal caregivers of people with dementia attending an outpatient geriatric assessment clinic. Aging and Society, 40(1), 205-228. doi: 10.1017/S0144686X18000971

  • Jorge C, Ceto M, Arias A, Blasco E, Gil MP, Lopez R, Dakterzada F, Purroy F, Pinol-Ripoll G. Level of understanding of Alzheimer disease among caregivers and the general population. Neurologia (Engl Ed). 2021 Jul-Aug;36(6):426-432. doi: 10.1016/j.nrleng.2018.03.004. Epub 2020 Feb 20.

    PubMed 34238525

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Structured Retrieval Practice, Business as usual learning and Standard Retrieval Practice in people with Dementia, run by Texas Christian University at 1 site 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 4 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 4 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 1 site 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 following first session). 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?

On the ClinicalTrials.gov record for NCT07377318, which also lists 16 linked publications.

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 4 Feb 2026.

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