DementiaNCT07413406
Comparing Structured Retrieval Practice and Reading-Based Education for Dementia Caregivers
A study testing Structured Retrieval Practice and Reading-Based Education in people with Dementia and Alzheimer Disease, run by Virginia Wesleyan University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease, Caregiver Stress
- What is being tested?
- Structured Retrieval Practice and Reading-Based Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uma Tauber, Ph.D contact
United States1 site, 1 recruiting
- Recruiting
Virginia Wesleyan University
Virginia Beach, Virginia, 23455
Robert Ariel, PhD, 757-455-3368, confidentcarestudy@gmail.com
Robert Ariel, PhD., psychology@vwu.edu
About this study
Official title: A Randomized Controlled Trial of a Care Partner-Centered Structured Retrieval Practice Intervention for Dementia Caregiver Education and Well-Being
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.
Read the detailed description
Caring for someone with dementia is often associated with high levels of stress, particularly when caregivers lack knowledge about how to manage behavioral and psychological symptoms of dementia (BPSD). Although educational resources for dementia caregivers are widely available, many are not designed using evidence-based learning principles that support long-term retention and application of information. Structured retrieval practice (SRP) is a learning strategy that enhances durable learning by requiring individuals to actively recall information over time while receiving corrective feedback.
This study is a longitudinal randomized controlled trial comparing an SRP-based educational intervention to a traditional reading-based education control condition. Informal caregivers of individuals living with dementia will be randomly assigned to one of two parallel arms. Both groups will receive educational content focused on managing dementia-related behavioral symptoms, coping strategies, and caregiver self-care; however, the format of instruction will differ by condition.
Outcomes will be assessed at baseline, and at 2-day, 2-week, and 2-month follow-up time points. Primary outcomes include caregiver knowledge retention, caregiving self-efficacy, perceived stress, and caregiver-reported severity of dementia-related behavioral symptoms. In addition, the study will evaluate intervention feasibility, acceptability, and adherence using self-report measures and backend program usage data.
Data will be collected either remotely or in person, depending on participant preference. The findings from this study will inform the development of evidence-based educational approaches that may be integrated into existing caregiver education programs and digital tools to better support families caring for individuals with dementia.
- Conditions
- Dementia, Alzheimer Disease, Caregiver Stress
- Being tested
- Structured Retrieval Practice, Reading-Based Education
- Keywords
- Dementia caregivers, Informal caregivers, Family caregiving, Structured retrieval practice, Retrieval Practice, Testing Effect, Caregiver Education, Caregiver Stress, Behavioral and psychological symptoms of dementia, Caregiver self-efficacy
- Medical subject headings
- Dementia, Alzheimer Disease, Caregiver Burden, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Retrieval PracticeBehavioural
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.
Reading-Based EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Reading-Based Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
Secondary outcomes (3)
Caregiver-Reported Dementia-Related Behavioral Symptoms
Caregiver perceptions of dementia-related behavioral and psychological symptoms will be assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q). Caregivers will indicate the presence and severity of symptoms across multiple behavioral domains. Composite scores will be calculated to reflect overall symptom presence and symptom severity, with higher scores indicating greater perceived symptom burden.
Measured: Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
Intervention Acceptability and Satisfaction
Participant satisfaction and acceptability will be assessed using the Client Satisfaction Questionnaire (CSQ-8), an 8-item self-report measure of satisfaction with health and educational interventions. Items are rated on a 4-point Likert scale, with higher scores indicating greater satisfaction and acceptability.
Measured: Immediately after completion of the intervention session.
Intervention Adherence
Intervention adherence will be assessed using backend program usage data capturing participants' completion of intervention sessions and engagement with assigned learning activities. Adherence metrics will reflect the amount of intervention content completed and exposure to the intended learning schedule.
Measured: During intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start3 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Wesleyan University
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Christian University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413406
- Sponsor's protocol ID
- ARDRAF-2025-ARIEL
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Care Partner-Centered Structured Retrieval Practice Intervention for Dementia Caregiver Education and Well-Being
- ClinicalTrials.gov ID
- NCT07413406
- Acronym / sponsor ID
- ARDRAF-2025-ARIEL
- Conditions
- Dementia, Alzheimer Disease, Caregiver Stress
- Keywords
- Dementia caregivers, Informal caregivers, Family caregiving, Structured retrieval practice, Retrieval Practice, Testing Effect, Caregiver Education, Caregiver Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Virginia Wesleyan UniversityUniversity, hospital or other
- Collaborators
- Texas Christian University
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Caring for someone with dementia is often associated with high levels of stress, particularly when caregivers lack knowledge about how to manage behavioral and psychological symptoms of dementia (BPSD). Although educational resources for dementia caregivers are widely available, many are not designed using evidence-based learning principles that support long-term retention and application of information. Structured retrieval practice (SRP) is a learning strategy that enhances durable learning by requiring individuals to actively recall information over time while receiving corrective feedback.
This study is a longitudinal randomized controlled trial comparing an SRP-based educational intervention to a traditional reading-based education control condition. Informal caregivers of individuals living with dementia will be randomly assigned to one of two parallel arms. Both groups will receive educational content focused on managing dementia-related behavioral symptoms, coping strategies, and caregiver self-care; however, the format of instruction will differ by condition.
Outcomes will be assessed at baseline, and at 2-day, 2-week, and 2-month follow-up time points. Primary outcomes include caregiver knowledge retention, caregiving self-efficacy, perceived stress, and caregiver-reported severity of dementia-related behavioral symptoms. In addition, the study will evaluate intervention feasibility, acceptability, and adherence using self-report measures and backend program usage data.
Data will be collected either remotely or in person, depending on participant preference. The findings from this study will inform the development of evidence-based educational approaches that may be integrated into existing caregiver education programs and digital tools to better support families caring for individuals with dementia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Structured Retrieval Practice (SRP) | Experimental | Behavioral: Structured Retrieval PracticeParticipants 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. |
| Reading-Based Education Control | Active comparator | Behavioral: Reading-Based EducationParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Retrieval PracticeThe 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. | Behavioural | Structured Retrieval Practice (SRP) |
| Reading-Based EducationThe 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. | Behavioural | Reading-Based Education Control |
Primary outcome
Caregiver Knowledge Retention
Time frame: Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
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.
Caregiver Self-Efficacy
Time frame: Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
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.
Caregiver Perceived Stress
Time frame: Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
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.
3 secondary outcomes
Caregiver-Reported Dementia-Related Behavioral Symptoms
Time frame: Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
Intervention Acceptability and Satisfaction
Time frame: Immediately after completion of the intervention session.
Intervention Adherence
Time frame: During intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. 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
Related trials for Dementia
Not yet recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-08161842 Are Tolerated and Act in the Body in Healthy and Older Adults
Alzheimer Disease
Active, not recruiting
Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise
Caregiver Resilience and Stress
Active, not recruitingObservational study
A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
RecruitingObservational study
Triage Survey for Neurology Research Eligibility
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Uma Tauber, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Retrieval Practice and Reading-Based Education in people with Dementia and Alzheimer Disease, run by Virginia Wesleyan 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 8 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: looking for participants now, as of the sponsor's last update on 17 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Ariel, PhD (757-455-3368, confidentcarestudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Knowledge Retention (time frame: Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.