NCT07377331

Brief 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 knowledge about the management of ADRD to real-world applied examples.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
4mo left

Started Nov 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Nov 2025Aug 2026

Study Start

First participant enrolled

November 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 14, 2026

Last Update Submit

January 22, 2026

Conditions

Keywords

dementiacaregivingknowledgetransferbehaviorial problems

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    2 days post-intervention (session 2)

Secondary Outcomes (8)

  • Delayed knowledge test performance

    2 days post-intervention (session 2)

  • Immediate knowledge test performance

    10 minutes post-intervention (session 1)

  • Medical Health Knowledge

    2 days post-intervention (session 2)

  • Demographic Characteristics

    Baseline and 2 days later

  • Self-reported Subjective health information

    Baseline and 2 days later

  • +3 more secondary outcomes

Other Outcomes (1)

  • Verification of Alzheimer's Disease or Related Dementia (ADRD)

    participant screening, pre-intervention

Study Arms (1)

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.

Behavioral: Structured Retrieval Practice (SRP)

Interventions

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.

Within-participant design with 2 learning conditions: intervention and reading control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informal caregivers
  • + 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.

You may not qualify if:

  • professional caregivers
  • former caregivers who are not currently caring for someone living with dementia
  • caregivers providing assistance to someone with normal cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas Christian University

Fort Worth, Texas, 76129, United States

RECRUITING

Virginia Wesleyan University

Norfolk, Virginia, 23502, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Uma Tauber, PhD

CONTACT

Robert Ariel, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Single-blind (outcome assessors blinded to condition assignment). Participants will be masked to study hypotheses, but may detect differences between the SRP and active control conditions during the learning phase.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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.
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

November 1, 2025

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

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

Locations