Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05017129 |
Other study ID # |
0327 |
Secondary ID |
5R44AG057239-03 |
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 15, 2020 |
Est. completion date |
December 31, 2024 |
Study information
Verified date |
January 2024 |
Source |
Klein Buendel, Inc. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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).