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CompletedNCT07377318Updated Feb 4, 2026

Project CARE-D - Online Caregiver Education for Dementia

A Phase 1 interventional study of Structured Retrieval Practice and Business as usual learning in Dementia, sponsored by Texas Christian University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Texas Christian University · Phase 1, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled May 2025, registered Jan 2026).
Phase
Phase 1
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

  • Dementia

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Keywords

  • dementia care
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 65 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Texas Christian University is the lead sponsor of 33 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Structured Retrieval Practice (SRP)

    Behavioral: Structured Retrieval Practice

  • Active comparator
    Standard Retrieval Practice

    Behavioral: Standard Retrieval Practice

  • Active comparator
    Self-paced Study

    Behavioral: Business as usual learning

Interventions

  • BehavioralStructured Retrieval Practice

    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.

  • BehavioralBusiness as usual learning

    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.

  • BehavioralStandard Retrieval Practice

    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.

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What researchers measure

Primary outcomes

  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.

    Time frame: 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.

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

Secondary outcomes

  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?"

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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)).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: Baseline

07

Study locations

1 site
  • Texas Christian University
    Fort Worth, Texas 76129, United States
08

References and documents

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 ↗
  • Hernandez MH, Mestres C, Modamio P, Junyent J, Costa-Tutusaus L, Lastra CF, Marino EL. Adverse Drug Events in Patients with Dementia and Neuropsychiatric/Behavioral, and Psychological Symptoms, a One-Year Prospective Study. Int J Environ Res Public Health. 2019 Mar 15;16(6):934. doi: 10.3390/ijerph16060934. PubMed 30875907 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07377318
Lead sponsor
Texas Christian University
Responsible party
Uma Tauber (Professor of Psychology, Texas Christian University) — Principal investigator
First posted
Jan 29, 2026
Start date
May 1, 2025
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025
Last update
Feb 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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