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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05497882
Other study ID # 336
Secondary ID R41AG078103
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 20, 2023
Est. completion date May 2024

Study information

Verified date May 2023
Source Klein Buendel, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The mission of corrections is to provide care, custody, and control for incarcerated individuals. United States prisons are required by law to provide adequate care for growing numbers of older people who are incarcerated-a group who are disproportionately at risk for Alzheimer's Disease and Related Dementias (ADRD). This Phase I project focuses on research and development of highly interactive computer-based learning modules, for prison staff and people who are incarcerated and serving as peer caregivers, to promote an integrated systems approach for enhancing the care of people with ADRD in prison.


Description:

U.S. prison systems face sharply increased demands in caring for older people living in prisons. Alzheimer's Disease and related dementias (ADRD) are age-related diseases. Prison populations are over-represented by minority populations who experience disparities in prevalence and incidence of dementia. Prison health, social, and security staff perceive they lack the skills and knowledge essential for identifying dementia and supporting people who are incarcerated and living with ADRDs. This unmet need may be due to a lack of standardized, feasible, and acceptable ADRD education programs that are tailored specifically for those managing and caring for people in the restrictive environment of prisons. Some prisons engage carefully vetted incarcerated people to be peer caregivers, assisting staff with care for people with ADRD. Training programs in prisons are often homegrown and lack consistency, which points to a need for evidence-based, current, and readily accessible training for both prison staff and peer caregivers that is focused on the care of people who are living with ADRD in prison. In response to this need, this Phase I Small Business Technology Transfer project, titled Computer-based Learning to Enhance ADRD Care in Prison: Just Care for Dementia, will demonstrate the scientific merit and feasibility of developing media-rich learning modules to train both multidisciplinary prison staff and peer caregivers on topics related to ADRD care. The specific aims of the project are to (1) transform best practices in ADRD care into media-rich, highly interactive, computer-based educational module prototypes to prepare corrections staff and peer caregivers to meet the growing care needs of people who are incarcerated and living with ADRD; and (2) conduct in-person usability testing of the learning module prototypes with corrections staff and peer caregivers to evaluate the user interface, ease of use, and perceived barriers in order to refine the product and optimize implementation in prison settings. In collaboration with an advisory board comprised of people with expertise in prison healthcare, training and technology, dementia in prisons, and experience with previous incarceration, the investigators will plan and develop discussion guides and then conduct focus groups with two groups of prison stakeholders: interdisciplinary corrections staff and inmates who serve as peer caregivers at a men's and a women's prison. Focus groups will ensure that design and technology plans match what is allowable for training in prison settings and will isolate essential ADRD content for the development of the comprehensive training program. Finally, the investigators will create and evaluate prototypes of media-rich, interactive computer-based learning modules for corrections staff and peer caregivers. At the end of Phase I, the investigators will have: a specifications document for the design of modules that at once fits with the technology available in corrections settings; is permissible to be used by people who are incarcerated; represents the critical learning needs of corrections staff and peer caregivers for providing ADRD care, and further develop collaborative relationships in preparation for commercialization of the product.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 52
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Prison staff: - work at a participating prison; - care for or manage people with ADRD in prison; - able to speak, understand and read English; - able to consent. Inmates: - have experience in caregiving; - able to speak, understand and read English; - able to consent. Exclusion Criteria: Prison staff: - not work at a participating prison; - do not care for or manage people with ADRD in prison; - cannot speak, understand or read English, - unable to consent. Inmates: - do not have experience in caregiving; - cannot speak, understand or read English, - unable to consent.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
E-Learning Prototype for Dementia Care
Usability testing System Usability Scale

Locations

Country Name City State
United States Barbara Walkosz Golden Colorado
United States Penn State University University Park Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Klein Buendel, Inc. National Institute on Aging (NIA), Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Focus Groups Focus groups will be conducted with interdisciplinary staff and peer caregivers. Data evaluation will include content and thematic analysis using constant comparative analyses methods. Focus groups will conducted in year 1. The analysis will be completed in Year 1 immediately following the conduct of the focus groups.
Primary System Usability Scale The System Usability Scale is a validated tool for assessing the usability and acceptability of technological products. Items on the System Usability Scale are rated from 1 (minimum) to 5 (maximum) with the higher number representing the better outcome. The usability test will be conducted in Year 1 and system usability scale will be administered in Year 1 following the conduct of the usability test.
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