NCT05017129

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2024

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

4.5 years

First QC Date

July 8, 2021

Last Update Submit

July 17, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Inmates Program Findings

    Evaluate improvements in knowledge among inmates

    Post-test (immediately following online training) approximately one hour

Secondary Outcomes (2)

  • System Usability Scale (SUS)

    After small-scale usability testing and at post-test for the large-scale testing. Approximately two hours

  • Qualitative questions

    After small-scale usability testing and at post-test for the large-scale testing. Approximately two hours

Study Arms (1)

Inmates Care modules

EXPERIMENTAL

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

Interventions

Inmates CareBEHAVIORAL

The single intervention is a computer-based learning program.

Inmates Care modules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Under the age of 18
  • Unable to speak and understand English
  • Prison Staff:
  • age \>18;
  • 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)
  • Under the age of 18
  • Unable to speak and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Study Officials

  • Barbara Walkosz, PhD

    Klein Buendel, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2021

First Posted

August 23, 2021

Study Start

June 15, 2020

Primary Completion

December 19, 2024

Study Completion

December 31, 2024

Last Updated

July 22, 2025

Record last verified: 2025-07

Locations