Computer-Based Learning to Enhance Dementia Care in Prison
Primary Purpose
Dementia, Prisoners
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-Learning Prototype for Dementia Care
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia
Eligibility Criteria
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.
Sites / Locations
- Barbara Walkosz
- Penn State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Training Prototype
Arm Description
Testing of 3 e-learning modules
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05497882
First Posted
July 27, 2022
Last Updated
May 2, 2023
Sponsor
Klein Buendel, Inc.
Collaborators
National Institute on Aging (NIA), Penn State University
1. Study Identification
Unique Protocol Identification Number
NCT05497882
Brief Title
Computer-Based Learning to Enhance Dementia Care in Prison
Official Title
Computer-based Learning to Enhance ADRD Care in Prison: Just Care for Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klein Buendel, Inc.
Collaborators
National Institute on Aging (NIA), Penn State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Prisoners
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training Prototype
Arm Type
Experimental
Arm Description
Testing of 3 e-learning modules
Intervention Type
Behavioral
Intervention Name(s)
E-Learning Prototype for Dementia Care
Intervention Description
Usability testing System Usability Scale
Primary Outcome Measure Information:
Title
Focus Groups
Description
Focus groups will be conducted with interdisciplinary staff and peer caregivers. Data evaluation will include content and thematic analysis using constant comparative analyses methods.
Time Frame
Focus groups will conducted in year 1. The analysis will be completed in Year 1 immediately following the conduct of the focus groups.
Title
System Usability Scale
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Loeb
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Walkosz
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Penn State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Computer-Based Learning to Enhance Dementia Care in Prison
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