E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-life Care in Prisons (P2P)

December 9, 2019 updated by: Klein Buendel, Inc.
The mission of corrections is to provide care, custody, and control for incarcerated individuals. United State prisons are required by constitutional law to provide adequate care for growing numbers of older inmates who will likely spend their final days in prison. This Phase I project focuses on research and development of highly interactive computer-based learning modules for inmate peer caregivers to promote an integrated systems approach to enhancing the care of the aged and dying in 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

The US has the highest incarceration rate in the world-imprisoning 693 people per 100,000. The older adult segment of the prison population has more than tripled since 1990 and their health issues are common to free people who are 10-15 years their senior. Inmates over the age of 55 have a death rate that is 10 times that of prisoners aged 25-34. US prison systems are facing sharply increased demands in caring for aged and dying inmates. A recent systematic review revealed that inmate peer caregivers can figure prominently in delivery of end-of-life (EOL) care in prison. However, the degree of training received by inmate peer caregivers varies widely. The lack of consistent training, both in content and duration points to a need for evidence based, current, and readily accessible training for this abundant human resource for meeting a growing need in US prisons. In response to this need, this Phase I STTR project, titled E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-Life Care in Prisons, will demonstrate the scientific merit and feasibility of developing cutting edge, media rich learning modules to train inmate peer caregivers in geriatric and EOL care. The specific aims of the project are to (1) transform best practices in inmate peer caregiving into a comprehensive training program that consists of media-rich and highly interactive computer-based learning modules for providing geriatric and EOL care to their peers; and (2) conduct in-person usability testing of the media-rich and highly interactive web-based prototypes with inmates who are currently Mental Health Peer Support Specialists (i.e., prisoners who are experienced caregivers, but naïve to geriatric and EOL care) to evaluate the user interface, ease of use, and perceived barriers in order to refine and optimize the product. In collaboration with an advisory board of experts in prison healthcare, geriatrics, ethics, palliative/hospice care, and oversight of an inmate peer support program, the investigators plan and develop discussion guides and then conduct focus groups with three groups of prison stakeholders: inmates who serve as peer caregivers for aged or dying peers; interdisciplinary staff who care for, or oversee care of aged and dying inmates; and training and information technology staff. One focus group with each of the above three constituent groups will be held at a men's and a women's prison. Focus groups will permit investigators to ensure that the design and technology plans match what is allowable for inmate training and will allow us to isolate essential geriatric and EOL content for specification in the development of the comprehensive training program. Finally, the investigators will create and evaluate prototypes of media rich, interactive computer-based learning modules for inmates serving as peer caregivers. At the end of Phase I, the investigators will have a specifications document for the design of modules that: fit with the technology available in corrections settings; is permissible to be used by inmates; represents the critical learning needs of inmate peer caregivers for assisting with geriatric and EOL care; and further develops the collaborative relationships in preparation for commercialization of the product.

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.
47

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, 16801
        • Penn 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

Genders Eligible for Study

All

Description

Inmate Inclusion Criteria:

  • Be a Mental Health Peer Support Specialist
  • Be 18 years or older
  • Able to speak, understand, and read English
  • Able to consent.

Inmate Exclusion Criteria:

  • Not be a Mental Health Peer Support Specialist
  • Under 18 years of age
  • Unable to speak, understand, and read English
  • Unable to consent.

Prison Employee Inclusion Criteria:

  • 18 years or older
  • Employed by a participating at a participating prison
  • Able to speak, understand, and read English
  • Able to consent

Prison Employee Exclusion Criteria:

  • Under 18 years
  • Not employed by a participating prison
  • Unable to speak English
  • Unable to consent

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: Other
  • 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: Training Prototype
Testing of 3 modules
Other: Prototype
Usability testing and System Usability Scale

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
System Usability Scale
Time Frame: 2 months
The System Usability Scale (SUS) is a validated tool for assessing the usability and acceptability of technology-based products. It contains 10 questions that are rated on a scale from 1 to 5. "The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100." A score of 68 is considered "above average." Anything below a 68 is considered "below average." The higher the score, the higher the usability of the product.
2 months

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
November 1, 2017

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.
April 30, 2019

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.
April 30, 2019

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).
October 24, 2017

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.
October 24, 2017

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.
October 26, 2017

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.
December 10, 2019

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.
December 9, 2019

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.
December 1, 2019

More Information

Terms related to this study

Keywords

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.
  • 1R41AG057239-01 (U.S. NIH Grant/Contract)
  • 03017 (Klein Buendel, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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