NCT07413406

Brief Summary

Caring for a person living with dementia can be stressful, and many family caregivers report limited access to effective educational resources for managing dementia-related behaviors and caregiver stress. This study will evaluate a learning-based educational intervention called structured retrieval practice (SRP), which is designed to improve long-term learning by encouraging repeated recall of information with feedback. Informal dementia caregivers will be randomly assigned to learn caregiving and self-care strategies using either SRP or a traditional reading-based educational approach. Participants will be assessed on their knowledge, confidence in caregiving skills, stress levels, and perceptions of dementia-related behavioral symptoms over multiple follow-up periods. The study will also examine whether the SRP intervention is feasible and acceptable for caregivers in real-world settings.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Oct 2025Jun 2026

Study Start

First participant enrolled

October 3, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 4, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

Dementia caregiversInformal caregiversFamily caregivingStructured retrieval practiceRetrieval PracticeTesting EffectCaregiver EducationCaregiver StressBehavioral and psychological symptoms of dementiaCaregiver self-efficacy

Outcome Measures

Primary Outcomes (3)

  • Caregiver Knowledge Retention

    Caregiver knowledge retention will be assessed using a researcher-developed multiple-choice assessment designed to measure factual and applied knowledge related to dementia symptom management and caregiver stress management. The assessment will consist of 64 items written at or below an 8th-grade reading level and tailored to each participant's selected learning content. Scores will reflect the total number of items answered correctly, with higher scores indicating greater knowledge retention.

    Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention

  • Caregiver Self-Efficacy

    Caregiver self-efficacy will be measured using the Revised Scale for Caregiving Self-Efficacy (RSCSE). The RSCSE is a validated self-report instrument assessing caregivers' confidence in managing stress, responding to disruptive behaviors, and controlling upsetting thoughts. The measure includes three subscales, each consisting of five items rated on a 0% to 100% confidence scale. Subscale scores will be summed to create composite indices, with higher scores indicating greater caregiving self-efficacy.

    Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention

  • Caregiver Perceived Stress

    Caregiver perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), a widely used self-report measure of perceived stress. Participants rate items on a 5-point Likert scale based on the frequency of stress-related experiences in the past month. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.

    Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention

Secondary Outcomes (3)

  • Caregiver-Reported Dementia-Related Behavioral Symptoms

    Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention

  • Intervention Acceptability and Satisfaction

    Immediately after completion of the intervention session.

  • Intervention Adherence

    During intervention period

Study Arms (2)

Structured Retrieval Practice (SRP)

EXPERIMENTAL

Participants assigned to this arm will receive caregiver education delivered using structured retrieval practice (SRP). Educational content will be presented through repeated opportunities to actively recall information over time with corrective feedback. Content will focus on managing behavioral and psychological symptoms of dementia, coping strategies, and caregiver self-care.

Behavioral: Structured Retrieval Practice

Reading-Based Education Control

ACTIVE COMPARATOR

Participants assigned to this arm will receive caregiver education delivered through traditional reading-based materials. Educational content will cover the same topics as the structured retrieval practice arm, including management of dementia-related behavioral symptoms, coping strategies, and caregiver self-care, but without retrieval practice or corrective feedback.

Behavioral: Reading-Based Education

Interventions

The structured retrieval practice intervention is an educational learning approach designed to support durable knowledge retention through repeated active recall of information with corrective feedback. Caregivers will engage in retrieval-based learning activities focused on dementia symptom management, coping strategies, and self-care. Learning activities will be spaced over time, and participants will receive immediate feedback to support learning and retention.

Structured Retrieval Practice (SRP)

The reading-based education control condition consists of caregiver educational materials presented in a traditional reading format. Participants will review written information covering dementia-related behavioral symptoms, coping strategies, and caregiver self-care. Materials will be matched in content to the structured retrieval practice condition but will not include active retrieval or feedback components.

Reading-Based Education Control

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 50 years or older
  • Informal (unpaid) caregiver for a family member or friend living with dementia
  • Providing ongoing assistance or support to the individual with dementia
  • Reports moderate to high perceived stress, defined as a score of 14 or higher on the Perceived Stress Scale (PSS-10)
  • Able to speak and read English
  • Able to complete study procedures either in person or remotely
  • Has access to a computer, tablet, or smartphone with internet access
  • Willing and able to provide informed consent

You may not qualify if:

  • Paid or professional caregivers (e.g., home health aides)
  • Caregivers younger than 50 years of age
  • Caregivers reporting low perceived stress (PSS-10 score below 14)
  • Caregivers providing assistance to an individual without evidence of cognitive - impairment, as determined by a dementia screening interview (AD8 score \< 2)
  • Inability to complete study procedures due to cognitive, sensory, or technological limitations
  • Failure to meet study screening requirements or provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Wesleyan University

Virginia Beach, Virginia, 23455, United States

RECRUITING

MeSH Terms

Conditions

DementiaAlzheimer DiseaseCaregiver BurdenBehavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesStress, PsychologicalBehavioral Symptoms

Central Study Contacts

Uma Tauber, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This is a single-blind study in which outcome assessors and data analysts are blinded to participant condition assignment. Participants are aware of their assigned learning format but are not informed of specific study hypotheses.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel study arms: a structured retrieval practice (SRP) based educational intervention or a reading-based educational control condition. Participants will remain in their assigned condition throughout the study and will complete assessments at baseline, 2 days, 2 weeks, and 2 months following the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 17, 2026

Study Start

October 3, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in publications will be shared via the Open Science Framework (OSF). Data will be de-identified prior to sharing to protect participant confidentiality. The dataset will be made available following study completion and publication of primary results. OSF project: https://osf.io/dq75t/?view\_only=adf58f00c01f440f8c762345aca0ccd9

Time Frame
Data will be available following study completion and publication of primary results.
Access Criteria
De-identified data will be made publicly available via the Open Science Framework (OSF) with no restrictions on access.
More information

Locations