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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).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 288
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Inmates Care
The single intervention is a computer-based learning program.

Locations

Country Name City State
United States Klein Buendel, Inc. Golden Colorado
United States Pennsylvania State University University Park Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Klein Buendel, Inc. National Institute on Aging (NIA), Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knowledge Acquisition 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)
Primary Inmates Program Findings Evaluate improvements in knowledge among inmates Post-test (immediately following online training) approximately one hour
Secondary System Usability Scale (SUS) 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
Secondary Qualitative questions 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
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