Computer-Based Learning to Enhance Dementia Care in Prison

November 12, 2024 updated by: Klein Buendel, Inc.

Computer-based Learning to Enhance ADRD Care in Prison: Just Care for Dementia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Golden, Colorado, United States, 80401
        • Barbara Walkosz
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Training Prototype
Testing of 3 e-learning modules
Behavioral: E-Learning Prototype for Dementia Care
Usability testing System Usability Scale

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Focus Groups
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.
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.
System Usability Scale
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Klein Buendel, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)
Penn State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan Loeb, Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 336/NOT a clinical trial
  • R41AG078103 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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