E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-life Care in Prisons

July 17, 2025 updated by: Klein Buendel, Inc.

E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-life Care in Prisons - Phase II

The demographics of the U.S. prison population are shifting at a dramatic rate requiring new approaches to prison healthcare. Current estimates suggest that there are 2.3 million incarcerated persons in the U.S. Similar to the free world, the aging of the Baby Boom generation is occurring in prisons. Notably, inmates 50 and older constitute over 20% of prisoners in state or federal facilities. From 1996-2016, there was an 280% growth in the number of state and federal prisoners age 55 or older, which is in sharp contrast to younger inmates that grew by only 3% during this time period. A surge in older adult offenders in the U.S. has not occurred but rather statutes now impose stiffer sentences, resulting in longer periods of incarceration, such as life without parole or 20+ years. At the same time, early release policies remain restrictive. As a result, sentenced offenders are living through middle and older adulthood within the confines of prisons.

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

There are over 1,719 United States (US) state and federal prisons with over 2.3 million prisoners. In 2017, more than 20% of sentenced prisoners were age 50 or older. The health status of older inmates is often parallel with free-living people who are far older (e.g., 10-15 years). Older prisoners disproportionately contribute to the steeply rising correctional healthcare costs and their death rate is 10 times that of younger prisoners. Corrections budgets are stretched as they strive to meet the care needs of aged and dying prisoners. Carefully selected and vetted inmates offer an abundant human resource that is poised to contribute in important ways to augment prison staff in meeting growing care needs of older and dying inmates. However, the lack of standardized, evidence-based, training that is geared toward this target audience is a current barrier to ensuring high quality inmate caregiving. In response to this need, our Phase I project E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-Life Care in Prisons demonstrated that inmate access to technology is growing and inmates can be successful e-learners. Specifically, we learned: (1) there is a need and interest for products such as our Inmates Care computer-based learning (CBL); (2) trainings should be engaging, interactive, and contextually sensitive to the specific environment, target user, and security constraints, while at the same time being mindful of emerging trends in regard to technology use by inmates (e.g., availability of tablets for purchase and use in many states); and finally, (3) that interactive, media-rich prototype modules with high acceptability and usability could be developed. The specifications document and commercialization plan indicated it is possible to develop a full-scale Inmates Care learning system in Phase II and a Technology Niche Analyses® revealed market potential exists. The purpose of this Phase II application is to continue research and development of the Inmates Care learning system with an emphasis on developing a scalable unit for commercialization and testing scale-up in a larger number of more diverse state prisons. More specifically, the aims of this Phase II study are to: 1) Develop a full scale media-rich interactive computer-based learning system Inmates Care, that consists of six modules aimed at augmenting the highly variable face-to-face inmate caregiving programs in state prisons with standardized, evidence-based training to prepare inmates in assisting with end-of-life (EOL) and geriatric care; and one Training Overview and Rollout module that prepares staff to use Inmates Care as a tool for inmate peer caregiver training; 2) Conduct in-person usability testing of the full-scale Inmates Care program in two rounds in state prisons to evaluate logistics, inmate and staff impressions, user interface, ease of use, and perceived barriers in order to optimize the scalable unit for broader dissemination (n=30); and 3) Test scale-up of the full-scale Inmates Care program in state prisons across the nation to evaluate knowledge acquisition outcomes, usage patterns, and commercialization opportunities (n=288).

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.
53

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 Locations

  • United States
    • Colorado
      • Golden, Colorado, United States, 80401
        • Klein Buendel, Inc.
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Pennsylvania 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Inmate Peer Caregivers:

  1. providing geriatric and/or EOL care at participating state prison (Aims 1 and 2 only);
  2. age >18;
  3. able to speak and understand English; and
  4. able to consent.

Exclusion Criteria:

  1. Under the age of 18
  2. Unable to speak and understand English

Prison Staff:

Inclusion Criteria:

  1. age >18;
  2. able to speak and understand English;
  3. able to consent; and
  4. have been exposed to inmate peer caregiving (e.g., through training them, oversight of a peer caregiving program, or working with inmate peer caregivers in the infirmary, personal care, or hospice area of prisons)

Exclusion Criteria:

  1. Under the age of 18
  2. Unable to speak and understand English

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: Health Services Research
  • 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: Inmates Care modules
This is a within-subjects, pre-post design with a single intervention. The intervention is a 6 module computer-based learning program for training peer caregivers in end-of-life care.
Behavioral: Inmates Care
The single intervention is a computer-based learning program.

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
Knowledge Acquisition
Time Frame: Pre-test (prior to online training- Total Score)
There are no existing measures to evaluate improvements in knowledge among inmates and staff for geriatric and EOL care of inmates. Therefore, the primary outcome measure will be developed for this project. Scale development and psychometric properties will be evaluated (e.g., content-validity, criterion-related validity, construct validity, and internal consistency) using: (1) domain identification and item generation; (2) content expert validation, and (3) pilot test.
Pre-test (prior to online training- Total Score)
Inmates Program Findings
Time Frame: Post-test (immediately following online training) approximately one hour
Evaluate improvements in knowledge among inmates
Post-test (immediately following online training) approximately one hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS)
Time Frame: After small-scale usability testing and at post-test for the large-scale testing. Approximately two hours
The SUS is a validated tool for assessing the usability and acceptability of technological products.
After small-scale usability testing and at post-test for the large-scale testing. Approximately two hours
Qualitative questions
Time Frame: After small-scale usability testing and at post-test for the large-scale testing. Approximately two hours
Six brief open-end questions that ask how helpful the program was, how the liked program was, and whether the user has any suggested changes to the program.
After small-scale usability testing and at post-test for the large-scale testing. Approximately two hours

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: Barbara Walkosz, PhD, Klein Buendel, Inc.

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.
June 15, 2020

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.
December 19, 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.
December 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 8, 2021

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 17, 2021

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 23, 2021

Study Record Updates

Last Update Posted (Actual)

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.
July 22, 2025

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.
July 17, 2025

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.
July 1, 2025

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.
  • 0327
  • 5R44AG057239-03 (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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Conditions

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Dietary Supplements

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