AgingNCT05017129
E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-life Care in Prisons
A study testing Just Care in people with Aging, run by Klein Buendel, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Just Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jun 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inmate Peer Caregivers:
- providing geriatric and/or EOL care at participating state prison (Aims 1 and 2 only);
- age >18;
- able to speak and understand English; and
- able to consent.
- age >18;
Show all 9Show fewer
- able to speak and understand English;
- able to consent; and
- 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)
Who cannot join
- Under the age of 18
- Unable to speak and understand English
- Prison Staff:
- Under the age of 18
- Unable to speak and understand English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Klein Buendel, Inc.
Golden, Colorado, 80401
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: 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.
Read the 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).
- Conditions
- Aging
- Being tested
- Just Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just CareBehavioural
The single intervention is a computer-based learning program.
| Study group | Role | What they receive |
|---|---|---|
| Just Care modules | Experimental | This is a within-subjects, 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 and one learning module for staff to implement a peer caregiving program at their respective facility. Receives: Behavioral: Just Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small-Scale Virtual Usability Testing - SUS Survey (System Usability Test)
Small-scale virtual usability testing participants were asked to complete the 10-item System Usability Test. The SUS, an industry-standard, assesses usability, including satisfaction, functionality, ease of use, and design. Items are rated on a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree) and were summed and multiplied by 2.5 to compute a total scale score. The minimum value is 0 and the maximum value is 100. The means of the Likert response items are calculated to determine the SUS score. The range of scores on the System Usability Scale (SUS) is 0-100. A score of 68 or greater reflects above average usability. Higher scores reflect greater usability.
Measured: Immediate post small-scale usability testing
Large-Scale Usability Testing - SUS Survey (System Usability Test)
Large-scale testing participants were asked to complete the 10-item System Usability Test. The SUS, an industry-standard, assesses usability, including satisfaction, functionality, ease of use, and design. Items are rated on a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree) and were summed and multiplied by 2.5 to compute a total scale score. The minimum value is 0 and the maximum value is 100. The means of the Likert response items are calculated to determine the SUS score. The range of scores on the System Usability Scale (SUS) is 0-100. A score of 68 or greater reflects above average usability. Higher scores reflect greater usability.
Measured: Immediate post large-scale usability testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start15 Jun 2020
- Primary completion19 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cognitive interviews and small-scale usability will be conducted prior to conducting the full-scale testing. The full-scale learning system (6 learning modules for inmates; 1 learning module for staff) will be tested in 12 state prison settings. We plan to use a pragmatic approach. Targeted participants to test the inmate-focused modules will include both current Inmate Peer Caregivers and inmates who are naïve to the caregiving role in prison. Staff participants to test the staff-focused module include, but are not limited to security, chaplaincy, medical services, psychology/counseling, and administrative leaders. The number of user-participants is dependent on the institution's size, but our target is to recruit 12 sites (three of which will be women's prisons) and an average of 20 inmates per site (n=240 inmates) to test the six modules that are developed for inmates and an average of four prison staff per site (n=48) to test the one module for staff.
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Penn State University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Barbara Walkosz, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017129
- Sponsor's protocol ID
- 0327
- Other IDs
- 5R44AG057239-03
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2021
- Last updated
- 31 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-life Care in Prisons - Phase II
- ClinicalTrials.gov ID
- NCT05017129
- Acronym / sponsor ID
- 0327
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Penn State University, National Institute on Aging (NIA)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Posted 31 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cognitive interviews and small-scale usability will be conducted prior to conducting the full-scale testing. The full-scale learning system (6 learning modules for inmates; 1 learning module for staff) will be tested in 12 state prison settings. We plan to use a pragmatic approach. Targeted participants to test the inmate-focused modules will include both current Inmate Peer Caregivers and inmates who are naïve to the caregiving role in prison. Staff participants to test the staff-focused module include, but are not limited to security, chaplaincy, medical services, psychology/counseling, and administrative leaders. The number of user-participants is dependent on the institution's size, but our target is to recruit 12 sites (three of which will be women's prisons) and an average of 20 inmates per site (n=240 inmates) to test the six modules that are developed for inmates and an average of four prison staff per site (n=48) to test the one module for staff.
| Arm | Type | Receives |
|---|---|---|
| Just Care modules | Experimental | Behavioral: Just CareThis is a within-subjects, 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 and one learning module for staff to implement a peer caregiving program at their respective facility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- providing geriatric and/or EOL care at participating state prison (Aims 1 and 2 only);
- age >18;
- able to speak and understand English; and
- able to consent.
- age >18;
Key exclusion criteria (5 listed)
- Under the age of 18
- Unable to speak and understand English
- Under the age of 18
- Unable to speak and understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Just CareThe single intervention is a computer-based learning program. | Behavioural | Just Care modules |
Primary outcome
Small-Scale Virtual Usability Testing - SUS Survey (System Usability Test)
Time frame: Immediate post small-scale usability testing
Small-scale virtual usability testing participants were asked to complete the 10-item System Usability Test. The SUS, an industry-standard, assesses usability, including satisfaction, functionality, ease of use, and design. Items are rated on a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree) and were summed and multiplied by 2.5 to compute a total scale score. The minimum value is 0 and the maximum value is 100. The means of the Likert response items are calculated to determine the SUS score. The range of scores on the System Usability Scale (SUS) is 0-100. A score of 68 or greater reflects above average usability. Higher scores reflect greater usability.
Large-Scale Usability Testing - SUS Survey (System Usability Test)
Time frame: Immediate post large-scale usability testing
Large-scale testing participants were asked to complete the 10-item System Usability Test. The SUS, an industry-standard, assesses usability, including satisfaction, functionality, ease of use, and design. Items are rated on a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree) and were summed and multiplied by 2.5 to compute a total scale score. The minimum value is 0 and the maximum value is 100. The means of the Likert response items are calculated to determine the SUS score. The range of scores on the System Usability Scale (SUS) is 0-100. A score of 68 or greater reflects above average usability. Higher scores reflect greater usability.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Walkosz, PhD principal investigator
Klein Buendel, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Just Care in people with Aging, run by Klein Buendel, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small-Scale Virtual Usability Testing - SUS Survey (System Usability Test) (time frame: Immediate post small-scale usability testing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.