- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07413406
Comparing Structured Retrieval Practice and Reading-Based Education for Dementia Caregivers
A Randomized Controlled Trial of a Care Partner-Centered Structured Retrieval Practice Intervention for Dementia Caregiver Education and Well-Being
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robert Ariel, PhD
- Phone Number: 757-455-3368
- Email: confidentcarestudy@gmail.com
Study Contact Backup
- Name: Uma Tauber, Ph.D
- Email: memorylab@tcu.edu
Study Locations
-
-
Virginia
-
Virginia Beach, Virginia, United States, 23455
- Recruiting
- Virginia Wesleyan University
-
Contact:
- Robert Ariel, PhD
- Phone Number: 757-455-3368
- Email: confidentcarestudy@gmail.com
-
Contact:
- Robert Ariel, PhD.
- Email: psychology@vwu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Structured Retrieval Practice (SRP)
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.
|
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.
|
|
Active Comparator: Reading-Based Education Control
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
|
|
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.
|
Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
|
|
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.
|
Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver-Reported Dementia-Related Behavioral Symptoms
Time Frame: Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
|
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.
|
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.
|
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.
|
Immediately after completion of the intervention session.
|
|
Intervention Adherence
Time Frame: During intervention period
|
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.
|
During intervention period
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARDRAF-2025-ARIEL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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