Project CARE-D - Online Caregiver Education for Dementia

NCT07377318 | Completed Phase 1

• 1 other identifier: 2024-153
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia

Keywords

dementia care

Outcome Measures

Primary Outcomes (2)

• 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.

  2 days following first session

• 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.

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

Secondary Outcomes (11)

• caregiver self-efficacy

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

• E-Health Literacy

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

• Letter and pattern comparison

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

• Raven's progressive matrices

  immediately following the intervention

• Vocabulary

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

Study Arms (3)

Structured Retrieval Practice (SRP)

EXPERIMENTAL

Behavioral: Structured Retrieval Practice

Standard Retrieval Practice

ACTIVE COMPARATOR

Behavioral: Standard Retrieval Practice

Self-paced Study

ACTIVE COMPARATOR

Behavioral: Business as usual learning

Interventions

Structured Retrieval Practice BEHAVIORAL

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.

Structured Retrieval Practice (SRP)

Business as usual learning BEHAVIORAL

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.

Self-paced Study

Standard Retrieval Practice BEHAVIORAL

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.

Standard Retrieval Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Christian University: lead

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76129, United States

Location

Related Publications (16)

• Fortinsky, R. H., Kercher, K., & Burant, C. J. (2002). Measurement and correlates of family caregiver self-efficacy for managing dementia. Aging & Mental Health, 6(2), 153-160. doi:10.1080/13607860220126763

  BACKGROUND

• 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

  BACKGROUND

• Ariel, R., Babineau, A., & Tauber, S. K. (2023). Teaching older adults to use retrieval practice improves their self-regulated learning. Aging, Neuropsychology, and Cognition, 31(5), 823-845. doi: 10.1080/13825585.2023.2271531

  BACKGROUND

• 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

  BACKGROUND

• Kaufer, D.I., Cummings, J.L., Ketchel, P., Smith, V., MacMillan, A., Shelley, T., Lopez, O.L., & DeKosky, S.T. (2000). Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. Journal of Neuropsychiatry and Clinical Neuroscience, 2(2), 233-239. doi: 10.1176/jnp.12.2.233.

  BACKGROUND

• 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.

  BACKGROUND

• Rawson, K. A., Gunstad, J., Hughes, J., Spitznagel, M. B., Potter, V., Waechter, D., Rosneck, J. (2010). The METER: A Brief, self-administered measure of health literacy. Journal of General Internal Medicine, 25, 67-71. doi:10.1007/s11606-009-1158-7

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• Norman, C. D., & Skinner, H. A. (2006). eHEALS: The eHealth literacy scale. Journal of Medical Internet Research, 8(4), e507. doi: 10.2196/jmir.8.4.e27

  BACKGROUND

• Woods, S. P., Babicz, M. A., Matchanova, A., Sullivan, K. L., Avci, G., Hasbun, R., Giordano, T. P., Fazeli, P., & Morgan, E. E. (2021). A clinical pilot study of spaced retrieval practice with a self-generation booster to improve health-related memory in persons with HIV disease. Archives of Clinical Neuropsychology, 36(7), 1296-1306. doi: 10.1093/arclin/acaa130

  BACKGROUND

• Tse, C., Balota, D. A., & Roediger, H. L. (2010). The benefits and costs of repeated testing on the learning of face-name pairs in healthy older adults. Psychology and Aging, 25(4), 833-845. doi:10.1037/a0019933

  BACKGROUND

• Sumowski, J. F., Wood, H. G., Chiaravalloti, N., Wylie, G. R., Lengenfelder, J., & Deluca, J. (2010). Retrieval practice: A simple strategy for improving memory after traumatic brain injury. Journal of the International Neuropsychological Society, 16(6), 1147-1150. doi: 10.1017/S1355617710001128

  BACKGROUND

• 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

  BACKGROUND

• Jorge, C., Ceto, M., Arias, A., Blasco, E., Gil, M. P., Lopez, R., Dakterzada, F., Purroy, F., & Pinol-Ripoll, G. (2021). Levels of understanding of Alzheimer disease among caregivers and the general population. Neurologia, 36(6), 426-432. doi: 10.1016/j.nrleng.2018.03.004

  BACKGROUND

• Hernández, M. H., Mestres, C., Modamio, P., Junyent, J., Costa-Tutusaus, L., Lastra, C. F., & Mariño, E. L. (2019). Adverse drug events in patients with dementia and neuropsychiatric/behavioral, and psychological symptoms, a one-year prospective study. International Journal of Environment Research and Public Health, 16(6), 934. doi: 10.3390/ijerph16060934

  BACKGROUND

MeSH Terms

Conditions

Dementia

Interventions

Commerce

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants are masked to study hypothesis. Analyses are conducted blind to condition assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 29, 2026
• Study Start: May 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)